Gene therapy brings life-changing medicines to patients and even the hope of a cure to those with chronic illness but the patient-specific nature and different operational requirements compared to traditional biologics create challenges in the transition to commercial viability. Process development and commercialization obstacles must be overcome fast. Swift optimization of scalable viral vector processes to meet the demands of clinical approvals and commercial cGMP manufacturing is needed to keep pace with rapid movement in the clinical landscape.
At Pall, we understand the uphill battle you are facing to deliver a robust, reproducible and scalable gene therapy viral vector process. We have the proven scalable technology, end to end integrated platforms, knowledge and services to help you get your gene therapy to market. Work with us to increase your speed to commercialization or to improve process productivity and deliver therapies to transform lives.
Partner with us to accelerate and optimise your viral vector process
The journey to industrialization is exciting and can be challenging at times but development and optimisation obstacles can be overcome with support from Pall’s experts. Our Accelerator℠ process development services, specialize in designing, optimizing, and transferring scalable processes from pre‐clinical to cGMP commercial manufacturing, reducing time to market. Our team can draw on experience from multiple gene therapy viral vector projects to collaborate with you.
In 2019, Zolgensma®, an AAV-based viral vector gene therapy used in the treatment of spinal muscular atrophy was approved by the FDA and Pall’s iCELLis® fixed-bed bioreactor is used in the production. Zolgensma’s journey began at the Center for Gene Therapy at The Abigail Wexner Research Institute of Nationwide Children’s Hospital and eventually made its way to Novartis.
Together we can rapidly optimize your process, whether to prove readiness for industrial scale production or to increase capacity.
Cell Expansion and Virus Production
Efficient transfection and scalable cell culture are two of the upstream hurdles to overcome. Our solutions support you to design a robust, reproducible and scalable process for generating viral vectors.
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Purification of Viral Vectors
The ratio of impurity to protein, the charge and size of viral vectors, and the risk of generating empty capsids create purification challenges. Optimized filtration and chromatography solutions maximize yield.
End-to-End Integrated Systems
An integrated system where all the unit operations are harmonized is the key to getting your process to run optimally to set performance criteria every time. Our keystone technologies combine to create robust but flexible integrated bioprocessing platforms. These preconfigured platforms can also be provided in a flexible POD® cleanroom from G-CON to further quicken a compliant manufacturing process.
Workflow solutions for adeno viral vector (AV) production
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Workflow solutions for lentivirus (LV) production
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Single-use, scalable cell culture options support suspension and adherent producer cell lines, cell expansion, viral transfection and virus production. All production systems are designed to maintain a sterile closed manufacturing environment and are automated to assure consistent operation and assure product quality.
Podcast: Evolution of culture systems for viral vector production: advantages, challenges and cost considerations
Published: March 10, 2020
Listen to this podcast interview featured on BioInsights, with Emmanuelle Cameau, Viral vector & Gene therapy technical Manager within the Pall Scientific Laboratory Servicesl, and Joseph Capone, Senior Global Product Manager at Pall.
Adherent Cells
One of the greatest challenges facing adherent cell processes is the scale-up to an industrial scale. Our unique fixed bed bioreactors are capable of simple scale-up maintaining closed system production with a small footprint across all scales.
iCELLis® 500+ system for manufacturing scale production (66 m2 to 500 m2)
iCELLis Nano for feasibility and small-scale production (0.5 m2 to 4 m2)
Xpansion® multiplate system, well suited for seed train operations for the iCELLis bioreactor range. (0.6 m2 to 12 m2)
Suspension Cells
For suspension cultures, a range of single-use, scalable stirred tank bioreactors and a bi-axial rocking system are available to support cell expansion and vector production at all scales.
Allegro™ STR stirred tank bioreactors for culture volumes of 10 L to 2000 L
Allegro XRS 25 bioreactor (rocking) system for cultures of 2 L to 25 L
The range of robust, scalable purification technologies effectively combine to reduce impurities such as residual plasmid DNA, host cell DNA and empty or partially filled vectors, to deliver the high purity, concentration and potency that you need.
Flexible, automated systems for chromatography and ultrafiltration permit the re-use of non-product wetted components and use single-use systems that are quick to install and eliminate the risk of batch to batch contamination. They can be applied to multiple stages within the process to eliminate cleaning and cleaning validation, minimize capital investment and accelerate batch turnaround times.
Podcast: Empty/full separation: gene therapy’s hidden challenge
Published: January, 2021
Listen to this podcast interview featured on BioInsights, with Mark Scoffield, Senior R&D Manager at Pall. With over 15 years of experience in R&D and new product development in biopharma related industries, Mark discusses how you can overcome the obstacle of AAV full capsid enrichment in your viral vector process.
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