Articles
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4 Key Considerations for Biopharma Companies Outsourcing Process Development
4 key considerations when finding the right CDMO for your outsourced process development needs.
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6 habits for keeping your lab equipment in good shape
See what simple habits can have an outsized impact on the reliability and longevity of your lab equipment.
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14 questions and answers on Fibro technology
Here we highlight and respond to the most common questions raised during the webinar: Rapid cycling protein A based fiber chromatography to address emerging downstream bottlenecks
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Accelerate flavivirus vaccine production
As with all viral vaccines, the complex nature of flaviviruses makes process development technically challenging. This article addresses how modern bioprocess tools and solutions can accelerate flavivirus vaccine production
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Accelerating an orphan therapy to market
This case study highlights how our Fast Trak Services team to help accelerate process development for cGMP production of material for toxicology studies.
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Accelerating bioreactor design with CFD modeling
As bioprocesses continue to intensify, efficient design and predictable scalability of equipment are key to reaching milestones on time. Here we share a process for accelerated design and scale-up testing for a next-generation bioreactor.
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Accelerating cGMP production using rapid tech transfer
A successful tech transfer is possible only with effective communication, diligent project management, and a wide range of technical and regulatory expertise.
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Accelerating VLP purification process development
Using mechanistic modeling to speed up the purification process development of virus-like particles (VLPs).
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Achieving operational efficiency in today’s fragmented market
Improving bioprocess efficiency is key to succeeding in a fragmented market. Use the latest technologies and solutions to do it without sacrificing flexibility.
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Adsorption isotherm models for chromatography
To create a complete chromatography model the adsorption of components within the adsorber beads needs to be considered. In this article we will discuss several of the most commonly used models for adsorption of proteins within a chromatography column.
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Air, gas, and vent filtration in biopharmaceutical production
Select the right air filtration solution from scalable formats for applications including stainless steel, high-temperature, highly oxidizing, and single-use operations.
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ÄKTA process™ flow accuracy and gradient performance
Having accurate flow is important for your chromatography systems to ensure you have reproducible results at different scales and when forming a gradient. We evaluated the gradient accuracy and range for different size ÄKTA process™ systems.
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Alkaline stability of Fc and VH3 binding in protein A resins
How the different binding sites of protein A are affected by extensive NaOH cleaning cycles
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Alkaline stability and lifetime of protein A resins
We perform a benchmarking study to compare the resin lifetime of MabSelect™ Prisma with other popular protein A resins.
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Amgen’s assessment of the SA25 aseptic filling workcell
Amgen discusses how the SA25 aseptic filling workcell could help meet business needs in high-mix, low-volume manufacturing.
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Amgen: Linking raw material data from suppliers to patients
By collaborating openly across the industry, we can minimize and control raw material risk and better manage our supply chain for the purpose of delivering the safest and most effective drugs possible.
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Analysis of Fortem bioprocessing film
Fortem™ single-use bioprocessing film technology: cell growth, carbon dioxide and oxygen transmission rates, flex fatigue, and other analyses.
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An innovative approach to manufacturing custom CDM with precision accuracy
Discover innovative analytical techniques for precision control of trace impurities in raw materials when manufacturing chemically defined cell culture media.
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Assessing leachables risk over a complete single-use mAb process
Process equipment-related leachables are mapped over a complete single-use mAb process at pilot scale.
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A small-scale model to increase yield in cell culture perfusion of mAb at large scale
Small-scale model for a monoclonal antibody (mAb) cell culture perfusion.
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A stepwise approach to a digital transformation in biopharma
Interview with two industry experts about the benefits of early adoption of automation in bioprocess manufacturing.
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Automated high throughput mAb purification using Fibro technology
Total run time was reduced 3- to 6-fold with Fibro PrismA. Recovery and critical product quality attributes were comparable to columns packed with MabSelect PrismA resin.
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Bacterial capsular polysaccharides
Purification platform for vaccine production
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Best practices for a successful bioprocess technology transfer
A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process.
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Bioburden control
Addressing microbial contamination
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Bioclear™ 10 and 11 films are comparable
Products with Bioclear™ 11 film are identical to Bioclear™ 10 products except for a lower TBPP content, show a greater ability to support TBPP-sensitive CHO cells, and can easily replace Bioclear™ 10 products.
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Biopharma: Addressing talent crunch in a growing industry
Gaining a skilled labor force in the growing biopharma industry can be a challenge. So what strategies should your company be considering for recruiting, training and retaining qualified bioprocessing candidates.
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Biopharma: How to win in emerging markets
Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?
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Biopharma reaches for homegrown talent
Though talent is vital to all industries it is particularly so for pharma and biopharma, making a shallow pool of local talent a real issue.
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Biopharma R&D needs more collaboration
Of all the lessons for Big Pharma from the Covid-19 pandemic, there is one that is likely to endure: collaboration.
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Bioprocessing 4.0
In combination with artificial intelligence, augmented reality, robotics, and digital twins, biopharma 4.0 changes legacy concepts from the ground up.
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Bioreactor oxygen
Importance of aeration and ways to control kLa during cell cultivation
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Bioreactor scale up and scale down: applications and tools
Bioreactor scale up and scale down are important but can be complex. Simplify with Cytiva’s web-based bioreactor scaling tool. View several case studies.
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Boost performance with a chromatography resin update
Why update your chromatography resins? To increase dynamic binding capacity, use less resin, and ease tech transfer for future biomanufacturing.
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Bridging the skills gap in biopharma
The growth of the biopharmaceutical industry depends on skilled workers. Routine training programs can help employees’ capabilities to effectively execute on process development and manufacturing operations.
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Buffer management solutions for large-scale biomanufacturing
Learn ways to resolve bottlenecks in the manufacturing process caused by buffer preparation.
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Building A Better Film For Single-Use Bioprocessing Through Effective Partnering
Choosing the right partner is key to addressing the challenges of implementing single-use technology.
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Building biopharma resilience through education and training
How biopharma organizations can apply innovative, new approaches for talent sourcing and to fill specialized-skills gaps to grow biomanufacturing resilience
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Can a shared biomanufacturing facility be the answer?
With a shared biomanufacturing facility, you can mitigate the risks of demand uncertainty using a flexible solution that allows you to grow and change in the new paradigm of biomanufacturing.
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Capture of bispecific antibodies and removal of product-related impurities
Protein L resins is an alternative to protein A, for capture of antibody Fabs, bispecific antibodies, and other molecules containing kappa variants of the variable light (VL) chain. Here we present data using an alkaline-tolerant, high-capacity resin.
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Case study: high throughput mAb purification with Fibro
A drug discovery lab finds that purifying antibodies with Fibro PrismA units means they can screen more candidates per week with a simpler equipment setup.
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Case study: virus reduction of an affinity capture step
This case study describes a successful viral clearance study for a protein A chromatography biomanufacturing step.
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CDMO or no CDMO . . . that is the question
By checking the pulse of your organization first, it is possible to identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.
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Cell culture FAQ
Information applicable to use of single-use bioreactors in cell culture applications.
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Cell culture media manufacturing FAQs
Here we answer some common questions about our cell culture media manufacturing sites around the world ― in Pasching, Austria; Tuas, Singapore; and Logan, Utah in the United States.
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Cell culture titer and protein quality
How media composition can maximize protein yield and quality attributes
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Cleaning components/external surfaces of ÄKTA process™ systems
Using common cleaning agents including ethanol/isopropanol and hydrogen peroxide/peracetic acid for effective cleaning
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Cleaning-in-place of ÄKTA process™ with sodium hydroxide
We will describe the cleaning procedure of ÄKTA process™ systems connected with inline dilution (ILD) units after challenging with a mixture of two microbial organisms.
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Collaborating to accelerate vaccine development
As the pharmaceutical industry continues to look for new and innovative ways to treat disease, some companies are putting more focus on how to prevent them.
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Concentrated fed-batch
Intensify your process by going from cell vial to 2000 L bioreactor in 1 step
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Connect and automate for efficiency
Data connectivity and comprehensive automation ease bioprocess tech transfer and scaling from process development to final manufacturing scale.
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Connected automated downstream process for mAb screening and evaluation
Learn about how a continuous automated process can save significant time and effort while maintaining product quality.
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Continuous chromatography
PCC chromatography + straight-through processing = intensified
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Cytiva attains Business Continuity Management System ISO certification
The certification covers emergency response, crisis management, and business continuity capabilities.
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HyClone single-use bags for liquid cell culture products
By in-sourcing manufacturing of our HyClone single-use bags for liquid cell culture products at the Cytiva cell culture center of excellence in Logan, Utah, we aim to reduce lead times of these essential products to better serve our customers.
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Designing a 1.5 L bench-scale model of a perfusion process
Establishing an appropriate small-scale model allows for higher throughput during operation at process conditions.
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Determining the power numbers for Xcellerex™ magnetic mixer
We calculated the power numbers for Xcellerex™ magnetic mixer in 2000 and 3000 L mixing tanks.
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Developing a closed connected single use mAb purification process
Explore a developed closed connected downstream purification process and learn how new technologies can provide improvements
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Developing a fit-for-purpose bioprocess film
The success of a single-use system depends on the components’ functionality, availability, and security of supply. We saw an opportunity to better support customers in all three with Fortem™ film for bioprocessing
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Developing a HIC polishing step for removal of mAb aggregates
In this article we focus on the development of a flow-through (FT) polishing step using hydrophobic interaction chromatography (HIC) to remove mAb aggregates.
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Developing a large-scale tangential flow filtration process
Using ÄKTA readyflux™ XL tangential flow filtration system and T-series Centrasette™ cassettes and Omega™ PES membranes for large-scale concentration and diafiltration.
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Developing a new biologic drug: regulatory challenges and considerations
Key milestones and planning ahead for compliance when bringing a new biologic drug to market.
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Developing HEK293 transfection media
Development of HEK293 transfection media prototype for transient protein expression and gene therapy applications
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Digital aids productivity and growth
Digital technologies can improve productivity and growth in cell therapy manufacturing and in bioprocessing.
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Digital manufacturing of biologics
The recent explosion in monitoring, analytics and new computing capabilities initiated the revolution called digital biomanufacturing. Learn how it can help biomanufacturers to improve their manufacturing processes.
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Digital transformation in biomanufacturing
Industry 4.0 uses digital connection and advanced analytics to improve bioprocess productivity. Digital transformation is how to get there. A Cytiva and Biogen case study illustrates the value.
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Direct adaptation of adherent cell lines in classical media
Classical media are often used to grow reference cell lines for life science research. Discover the options for direct adaptation of common adherent cell lines.
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Direct flow filtration FAQ
Frequently asked questions about the use and performance of filter cartridges and capsules in air, gas, vent, microbial control, and particulate filtration.
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Discovery to delivery in 100 days
Covid-19 changed the vaccine manufacturing landscape.
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Doubling up for speed in biomanufacturing
Parallel operations affords the opportunity to develop a process in a parallel path using the resources of an external CDMO partner while simultaneously establishing your manufacturing capabilities.
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Downstream process characterization
Mechanistic process models can be applied in all stages of PC/PV from process design space development up to linkage studies
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Driving flexibility and efficiency with integrated automation
Discover how integrated automation strategies in single-use biomanufacturing can help you improve facility operations, data capture, and product quality.
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Dry powdered medium milling equivalency study
Study compares powdered cell culture medium production using Sturtevant and Hosokawa pin mills. Physical, chemical, and biological data including cell growth.
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Dynamic binding capacity in fiber-based chromatography
Determining the DBC of Fibro PrismA for your molecule is a key step in your process. Learn how and why in this article.
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Efficient and scalable buffer preparation
Two ways to use the quaternary valve of an ÄKTA avant chromatography system for buffer preparation – scale up to an inline conditioning system or scale down for robustness studies.
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Efficient chromatography buffer prep with inline dilution
We evaluate the performance of integrated inline dilution technology on the ÄKTA process™ chromatography system, and assess process economy factors — including cost, labor, time, and space requirements — versus manual buffer preparation .
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Efficient protein A chromatography for bispecific antibodies
Bispecific antibodies (BsAb) can be purified using protein A chromatography in only a single step. BsAb constructs were efficiently purified to give more than 90% purity and 85% yield in the early screening downstream process.
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Emergent BioSolutions selects the SA25 aseptic filling workcell
Emergent BioSolutions selects Cytiva’s SA25 aseptic filling workcell, supporting their requirements for product quality, sterility assurance, and flexibility.
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Engage a mechanistic modeling expert – or become one
When using mechanistic models, is it better to develop expertise in-house or outsource?
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Ensuring the viral safety of final drug products
Using orthogonal technologies to inactivate and/or remove viruses can help ensure the viral safety of your final drug product.
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Establishing a robust workflow to identify high-performing GOCHO™ clones
This study explores an alternative approach to cell line development which is more robust and increases the chance of delivering highly productive clones.
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Evaluating leachables from extractables data
A practical approach on how to use supplier extractables data and best practices to assess leachables risk over a complete 2000 L single-use manufacturing process
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Evaluating the economics of today’s biomanufacturing strategies
Buy vs build: what is the best strategy to establish and maintain efficient and productive manufacturing operations? Here is what ArmaGen decided to do.
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Evolution of downstream process development methods
Explore how downstream process development methods have evolved from DoE, HTPD, and platform knowledge, to mechanistic modeling.
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Extractables and leachables
Regulations for extractables and leachables in single-use bioprocessing materials frequently change.
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FAQs about Cytiva™ Protein Select™ technology
With questions covering a range of topics from principles to protocols, we’ve heard from scientists who are interested in learning more about Cytiva™ Protein Select™ technology. Their questions and our answers are collected here — scroll through them and you might find the answers you need.
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Fermentation
Which offers better process economy and production capacity: single-use or stainless?
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Fiber-based protein A chromatography for HTPD
Study evaluates research-scale units and 96-well plates in applications for high-throughput monoclonal antibody purification.
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Fibro mAb chromatography scaleup
Evaluation of Fibro PrismA for scalable single-use mAb purification
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Filter performance in high concentration formulations
Performance of sterilizing grade filters in drug formulations for subcutaneous injection: A throughput benchmarking study with Supor® Prime membrane
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Filtration
How to efficiently concentrate a low-titer antibody sample
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Filtration methods to overcome new challenges in viral safety
Novel filtration methods in bioprocessing to overcome new challenges in viral safety
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Flavivirus vaccine
Accelerate production with modern tools and solutions
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Flow and gradient accuracy using ÄKTA pilot 600 system
Accurate flow and gradient performance are important to provide reproducible chromatography results at different scales. In this study we investigated flow and gradient accuracy of the ÄKTA pilot 600 chromatography system.
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Fluid handling FAQ
Information applicable to use of single-use technologies for biotechnology and pharmaceutical applications.
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Freeze and Go solutions protected by RoSS technology
Protect the integrity of biocontainer bags from mechanical damage due to manual handling and minimize product loss due to uncontrolled freezing.
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Future of eData exchange in the biopharmaceutical industry
Electronic data exchange is crucial to assuring of both the quality and consistency of raw materials in biomanufacturing. Learn how BioPhorum is advocating for digital delivery of raw material data.
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Gain efficiency in process development
Learn how fellow scientists use ÄKTA avant to gain efficiency in protein purification process development
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Generating a robust host cell line, GOCHO™, for a cell line development platform
Discover how to establish a host cell line with your desired growth characteristics that can also seamlessly switch between cloning and production media.
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Get started with MabSelect™ PrismA protein A resin
Use this quick guide as a starting point for monoclonal antibody purification using MabSelect™ PrismA protein A resin. These tips are suitable for most mAbs and many mAb-derived molecules.
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Global or local? Biopharma’s supply chain challenge
Drug shortages are common, especially in the face of unpredictable and fluctuating demand. The Global Biopharma Resilience Index points to critical local and global supply chain challenges.
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Good modeling practice
How to ensure accurate model calibration for your mechanistic models.
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Guide to polishing chromatography in process development
From the basics to the typical challenges and how to overcome them.
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High quality resins manufacturing during a pandemic and beyond
Cytiva aims to ensure security of supply of our chromatography resins. Learn more about the complex resin production process in this article.
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How customer forecasts support the integrity of the biopharma supply chain
A review and best practice guide for customer forecasting and the role it plays in ensuring security of supply in biopharma
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How mRNA technology came to the rescue
While the COVID-19 pandemic shone a light on mRNA, scientists have been working for decades to see how it might help fight disease. Today, researchers are working on treatments for genetic diseases like cystic fibrosis, or liver and muscular diseases.
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How the industrial internet of things is transforming Bioprocessing
Digitalization means a more productive and adaptive plant through the application of analytics…
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How to do a multiple peak comparison in Fibro chromatography
Learn how to perform a multipeak comparison for Fibro chromatography units. We demonstrate ways you can generate large numbers of chromatograms and directly gather a great deal of data from each run.
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How to pack Capto™ HIC resins using verified packing methods
We explain the best practices to help you efficiently pack Capto™ HIC resins in our large-scale AxiChrom™ chromatography columns
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How to pack Capto™ ImpRes resins using verified packing methods
Packing guidance for successful packing of Axichrom™, BPG, and Chromaflow™ columns
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HyClone characterized FBS ‒ origin equivalence study
Characterized FBS from US, NZ, and AUS show comparable performance and low variability.
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Improve PD efficiency
Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. Here we give some insights on tools to make process development more efficient.
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Improving Biomanufacturing Resilience in an Uncertain Future
Read these biomanufacturing insights to understand how industry collaborations and strategies can help improve biomanufacturing resilience in an unpredictable but promising future.
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Increasing productivity in hydrophobic interaction chromatography (HIC) using Capto resins
In this study we demonstrate productivity gains using Capto resins in hydrophobic interaction chromatography. Relative hydrophobicity of a resin is dependent upon sample composition, emphasizing the importance of testing resin hydrophobicity for each biomolecule.
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Influenza vaccine
Production process using single-use bioprocessing equipment
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In-process testing of hollow fiber filtration membranes
How do you build quality into a hollow fiber cartridge? Make sure you have quantitative information on the pore structure of the hollow fiber membrane. Cytiva uses a method called capillary flow porometry to do just that.
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In silico approaches towards automated biomanufacturing
Mechanistic modeling can be used to support several activities in biopharmaceutical production, including process transfer activities, in silico troubleshooting, process analytical technologies, and automated biomanufacturing.
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Integrating automation in a biomanufacturing environment
Integrating automation can become a daunting task without the right preparation and a clear implementation strategy. Through proper planning, you can eliminate costly errors and missteps.
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Integrity testing FAQ
Frequently asked questions about filter integrity testing using Palltronic™ instrumentation.
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Intensified chromatography strategies
Explore downstream operations to improve biomanufacturing productivity, speed, and flexibility. Options include improved resins, prepacked columns, continuous chromatography operations, and fiber-based chromatography.
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Intensifying your fed-batch process using cryobags
In this article we compare conventional seed train methods to the use of a high-cell density cryobags. We show that high-density cryobags can be used to seed a bioreactor at a 500-fold higher seed density, reducing total process time by up to nine days.
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Is your single-use facility designed with the end in mind?
Up-front design considerations can improve your long-term processing flexibility and ability to expand
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Knowledge management with GoSilico™ Chromatography Modeling Software
Using GoSilico™ Chromatography Modeling Software it is easy to manage and share the growing process knowledge within a team throughout the product lifecycle.
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Large-scale perfusion cell culture
We have sucessfully conducted a large-scale scale perfusion run using Xcellerex APS connected to an Xcellerex XDR 50 bioreactor.
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Lessons learned executing a closed connected processing from start to finish
Insights and recommendations for designing and executing a connected single-use , perfusion monoclonal antibody manufacturing process. These findings are based on a practical process run at 50 liter scale.
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Making policy work for the biopharma industry
To deliver life-saving drugs more quickly, biopharma must work in harmony with governments and regulators.
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Manage process development data
Data management is a key element of the drug development process. Learn about the challenges of today’s methods and new solutions to successfully overcome them.
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Manufacturing agility on the ground
Many firms have taken a lead on manufacturing changes already, including Samsung Biologics and Amgen. We sit down with each of them to find out how they have achieved manufacturing agility, and what lessons the wider industry can take away.
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Manufacturing of viral vectors
For use in gene therapy and development of therapeutic vaccines
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Mechanistic modeling for downstream processing: digital twins are here to stay
Possible strategies using digital twins of downstream processes.
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Mechanistic modeling of chromatography
This article explores the opportunities and challenges with using mechanistic modeling for chromatography.
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Mechanistic vs statistical models
Learn on the differences between statistical and mechanistic models, and their use in improving your process development.
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Effective mixing of media and buffer powders using the Xcellerex™ magnetic mixer
We evaluated the mixing performance of the 3000 L Xcellerex™ magnetic mixer system for preparation of aqueous solutions.
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Membrane chromatography FAQ
Frequently asked questions regarding the use of membrane chromatography equipment.
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Monoclonal antibodies
Intensify downstream processing of mAbs with innovative, integrated approaches
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Multidimensional scale-up using ÄKTA pilot 600 system
In this study we demonstrate a 20-fold multidimensional mAb capture step scale-up. Read how equivalent mAb recovery and purity was achieved between the larger and smaller scales using an ÄKTA pilot 600 chromatography system.
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N-1 perfusion improves your fed-batch process
High-density N-1 perfusion allows 10-fold higher seed density in the final production cell culture.
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New drug process development
Meeting the process development challenges of a diverse biologic pipeline How to navigate the evolving biopharmaceutical landscape from a process development standpoint.
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Next generation bioprocesses: Mapping roads to the future
Explore available options to select a path based on molecule and facility needs
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Novel protein therapeutics and peptide therapeutics
The growing complexity of peptide and protein therapeutics brings unique challenges and the need for refined processes and technologies to develop and produce them. Learn more about solutions for bispecific antibodies and antibody-drug conjugates.
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Nucleic acid therapeutics and environmental impact
Nucleic acid therapeutics are offering researchers exciting new avenues of treatment. Learn what steps can be taken to minimize environmental impact while manufacturing and distributing these therapies.
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Optimization of a hydrophobic interaction chromatography step for recombinant protein purification
How to develop a purification workflow for a protein expressed in E. coli using HIC.
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Optimization of a two-step purification method for bispecific antibodies
Downstream processing of a bispecific antibody cancer therapeutic using antibody purification chromatography in two steps.
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Overcome chromatography challenges with fiber adsorbents
Innovative technology for chromatography process scale-up.
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Packing MabSelect PrismA in BioProcess columns
Verified column packing methods for MabSelect PrismA chromatography resin.
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Perfusion culture with ATF cell retention
Perfusion culture of an antibody-producing CHO cell line, with alternating tangential flow filtration (ATF) for cell retention. Uses an XDR-10 bioreactor system, hollow fiber filter cartridge, and diaphragm pump.
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Perfusion culture with TFF cell retention
Perfusion culture of an antibody-producing CHO cell line, with tangential flow filtration (TFF) for cell retention. Uses an XDR-10 bioreactor system and hollow fiber filter cartridge as cell retention device.
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Preparing for the future of biomanufacturing
New market dynamics are reshaping how biologics are produced and sold. Here’s what six industry experts say about the way forward.
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Process considerations for closed connected processing
Considerations for aligning design space for multiple connected single-use processes to ensure operational flexibility and efficiency resulting in a high quality product.
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Process development challenges for mRNA vaccines and beyond
mRNA vaccines took center stage in 2020 as the world’s best chance at beating back the COVID-19 pandemic. But to realize the full therapeutic potential of mRNA, we must address challenges in process development.
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Process understanding empowered by mechanistic models
Mechanistic models are based on physical and biochemical effects and allow the examination of positive or negative effects on the process before they occur in production.
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Protein L affinity resin is ready to move to manufacturing
After comparing resin performance for mAb, Fab, and dAb samples, MabSelect™ VL protein L resin offered increased binding capacities versus other resins. This improvement could address existing protein L resin limitations in biomanufacturing processes.
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Purification of plasmid DNA
Collaborative Development of a Next-Generation Chromatography Resin for the Purification of Plasmid DNA
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Purposeful design and development of a next-generation single-use bioprocess film
Biomanufacturing requires a film technology specifically designed for working with biologics.
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Quality by design in single use-systems
Learn how to use consolidated data from our advanced central management system for single - use system component selection
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Quantitative assessment of desirability of platform cell culture media
In this study, we compare platform cell culture media with clone - specific media and assess the quantitative difference in their performance.
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Raw material variability: the need for deeper process understanding
The importance of resin variability characterization for obtaining robust chromatography polishing processes
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Reducing bioburden on a protein A resin
How a protein A affinity resin was safely sanitized while preserving high mAb yield and purification performance.
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Resin slurry concentration
Accurate determination for optimal column performance
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Risk assessment: when to study chromatography resin variability
How do you identify which parameters and interactions to focus on in your process characterization studies?
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Robust business continuity program helps to maintain operations in the face of crisis
A business continuity management strategy is key to reducing risks and downtime, and maintaining quality. Cytiva has implemented several initiatives to help mitigate risk and ensure security of supply in the face of global challenges.
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Sanitization: AxiChrom columns
Peracetic acid (PAA) was evaluated as sanitization agent in the packing and repacking of a protein A resin in AxiChrom 300 column.
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Sanitization of the ÄKTA pilot 600 chromatography system
In this study we evaluated the predefined sanitization methods for the ÄKTA pilot 600 chromatography system.
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Scalable ADCF virus production using HyClone VaccineXpress medium
HyClone VaccineXpress cell culture medium promotes the production of inflective influenza…
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Scale up E. coli for plasmid DNA production
How to effectively scale up E. coli growth, plasmid titer, and percentage of supercoiled plasmid DNA up to production scale in fermentors.
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Scaling a mAb production process to Xcellerex bioreactors
Moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform
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Scaling Fibro chromatography
Evaluation of Fibro rapid cycling chromatography for its performance and scalability for downstream chromatography mAb processes.
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Scale-up and scale-down with mechanistic modeling FAQs
See how to apply a mechanistic model to scale-up and scale-down your chromatography process.
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Securing bioprocess film supply
Transparency across the single-use film supply chain helps to ensure security of supply for single-use bags.
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Securing today’s biomanufacturing supply chain using transformative supply
Compared to just a decade ago, managing the biopharmaceutical supply chain has become a far more complex topic.
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Shifting biopharma’s manufacturing into the fast lane
As the past year has shown, the ability to be both malleable and swift are powerful assets in the face of virulent diseases.
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Simple fed-batch process development for a knockout cell line
This workflow improved titers 500% compared with CHO cell culture in basal medium.
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Simulating downstream processes in the growing molecular diversity
Mechanistic modeling of chromatography is not just applicable for mAbs. It also applies to bispecific antibodies, ADC, peptides and more.
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Single-use chromatography
Adapting to manufacturing scale
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Single-use technologies are here to stay. How can we improve their supply
The use of single-use technologies has been growing steadily, but supply constraint is a key challenge for the biopharma industry. This article discusses the potential solutions for improved supply.
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Sodium hydroxide sanitization of chromatography resin in AxiChrom™ columns
We develop a method for sanitization of Capto™ mixed-mode resins using 1 M sodium hydroxide (NaOH) as sanitization agent.
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Storage condition effects on fetal bovine serum
Exposure to a wide range of temperatures and storage durations does not affect performance of fetal bovine serum for various cell lines
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Strategies for viral vector manufacturing
Accelerating the production of viral-vector based therapy requires both understanding of strategies available to address the viral vector manufacturing shortage and how to select the most cost-effective solution for your next-generation therapeutic.
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Studying resin variability using a Process Characterization Kit
Learn how variability of resin ligand density may impact product quality and process performance.
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Suppliers' contributions to bioprocessing advances
From platform processes to disruptive technologies: The future of innovation continues.
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Supply chain raw material variability
Increased development of biological drugs has reinforced the demand for heightened material controls. Raw materials like cell culture media can have a major impact on the robustness of the biomanufacturing process and, ultimately, on the drug itself.
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Tackling supply chain security with multi-site manufacturing
Cytiva is focused on maintaining supply chain security through multi-site manufacturing. Learn more about resilient manufacturing for single-use technologies and beyond.
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Tangential flow filtration (TFF) FAQ
Using membrane devices, hardware, and systems for tangential flow filtration (TFF).
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The antibody boom
Antibodies continue to dominate the biopharma market. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.
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The biopharma supply chain
In a conversation with Adrian van den Hoven, director general of Medicines for Europe, which represents the generic and biosimilars industries, we find out how supply chain challenges are playing out in biopharma vs generics, and what industry leaders expect to change in the future.
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The biopharma talent pool
We speak to senior leaders at pharma giant Amgen and biotech powerhouse Samsung Biologics to find out more about talent risk and to hear what they are doing to secure the best workers.
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The colloidal particle adsorption (CPA) model in IEX
GoSilico™ Chromatography modeling Software has introduced an adsorption isotherm class that is based on a colloidal description of proteins, which achieves increased accuracy at high column loading in IEX modeling.
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The good and bad of biosimilars
The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.
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The pandemic impact: focusing on security of supply
The pandemic changed how biopharma manufacturing companies manage security of supply. Find out how Cytiva is addressing the challenges—and what lessons the wider biopharma industry can take forward.
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The past and future of managing raw material and process risks in biomanufacturing
Managing raw material supply and variation is a critical challenge in bioprocessing. This article addresses the three key areas of supply chain transparency, consistency, and risk.
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The path to immunoassay reagent development
Guidelines for developing immunoassay reagents using technolgies such as Biacore surface plasmon resonance
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Three-step supercoiled plasmid DNA purification
Achieve high purity of supercoiled plasmid DNA in this three-step process. Shows data for scale-up to pilot scale.
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T-series TFF cassettes with Delta 100 kDa membranes for RNA and LNP applications
Evaluating the performance of TFF cassettes with 100 kDa molecular weight cutoff membranes for effective tangential flow filtration of RNA and LNPs
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The top trends influencing automation in the life science industry
How will multi-product manufacturing facilities, single-use technologies, continuous manufacturing and industry 4.0 impact automation in the life science industry?
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The transparent CDMO
Handing over vital information about your product can be very unnerving. That is why it is important to find a CDMO who can help alleviate drug development risks and protect your intellectual property (IP).
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Towards a better process outcome
Considerations for improving outcome in biopharmaceutical process development
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Two-step chromatography for efficient Fab purification
Effective Fab fragment purification with ÄKTA go™ chromatography system and MabSelect™ affinity chromatography resins
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Understanding and controlling raw material variation in cell culture media
Manage variability through advanced analytical methods and risk-based assessment
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Under pressure: 4 root causes of single-use mixer leaks
Process efficiency isn’t just about what your equipment can do – it’s also about how well it performs. Failed steps, such as leaks, in a large-scale bioprocess are costly in terms of material loss and downtime. Learn about common causes here.
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Understanding fluid dynamics within a chromatography column
See how fluid flow effects within a chromatography column are used by mechanistic models
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Using in-line sensors for real-time control
This paper exemplifies how to use available and reliable sensors for in-process control of several different upstream and downstream process parameters.
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Vaccines
Accelerate cell-based vaccine production with modern tools and solutions
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Vaccines: A balancing act
Although absolutely crucial for maintaining global health, vaccines are challenging to develop and manufacture. How can businesses ensure profitability while maintaining low prices for developing countries?
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Viral clearance study basics
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. Here is an overview of the fundamentals of viral clearance studies related to the chromatography steps in a bioprocess.
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Viral vector manufacturing: the key to the success of gene therapy
Frost & Sullivan recently invited industry thought leaders working in the viral vector manufacturing space to participate in our Virtual Think Tank (VTT), a unique thought leadership platform that brings together leading minds, to discuss viral vector manufacturing facility design.
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Virus and exosome purification: harness core bead technology
Using core bead technology to fine tune impurity removal and maximize recovery of large entities
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What are mechanistic chromatography models?
Creating a predictive model of your downstream process using mechanistic chromatography models based on natural science.
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Wonderware automation for the Cytiva FlexFactory
At the heart of FlexFactory, bioprocess automation drives unit operations in bioprocess installations. The central nervous system of FlexFactory, bioprocess automation coordinates control and consolidates data
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WuXi Biologics implements the SA25 aseptic filling workcell
WuXi Biologics moves from purchase order to GMP batch release in 15 months, with 7 vial, syringe, and cartridge formats validated.
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Xcellerex APS intensified seed culture for a fed-batch process
Process we developed produced 179 MVC/mL in a 50 L bioreactor.
Tools
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Bioprocess filtration
Calculators and converters for tangential and normal flow filtration
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Bioreactor scaler tool
Save time optimizing your cell culture as you scale up or down in the Xcellerex XDR platform
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Chromatography
Calculators, converters, and selection guides for chromatography
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Life sciences online courses
Browse our free eLearning courses and grow your skills
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Process intensifier app
Discover the right intensification strategy for your process by entering your upstream and downstream process parameters
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Technical handbooks
Principles and methodology handbooks covering bioprocess techniques and applications
Videos and webinars
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Chronicle™ Software: Automating batch records
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Chronicle™ Software: Mitigating risks in production
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Chronicle™ Software: Scaling for needs in cell therapy
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Fortem single-use platform film built for bioprocessing
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KUBio: The proven response for rapid biomanufacturing
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ReadyToProcess prepacked, validated columns
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Single-use TFF system: ÄKTA readyflux
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Webinar Hub