Bioprocess Vision - Issue 1 - April 2011



Regional Versions (PDFs):

Market Trends

Sterile Disconnectors for Risk Reduction During Fluid Transfer

The trend towards single-use systems for bioprocessing creates an increasing demand for single-use components. One example is the need for a secure tubing disconnection mechanism that removes the risks associated with clamping and cutting, preserves product integrity, improves operator safety, and reduces product waste. It should maintain the integrity of sterile fluid paths before and after separation of tubing.

Industry is asking for sterility and bioburden management around a range of applications including media preparation, product transfer between bioreactors, buffer preparation, waste removal, and holding of product intermediates or bulk product.

A disconnection device should ensure that flow paths cannot be reopened or reconnected following disconnection, thus further securing product integrity.

Disconnection should be able to be performed in a few simple steps in a quick manner, and sterility or containment of the separate fluid paths should be maintained throughout. The process should be compatible with single-use or hybrid systems. One example is the filling of a product into a biocontainer, where it is then frozen and later returned to a controlled environment for further processing.

The launch of the Kleenpak™ Sterile Disconnector as an innovative solution for sterile disconnection, even in uncontrolled environments, represents a major improvement to single-use technology in aseptic processing. It can be used at all stages of the process, but will be particularly valuable in upstream and formulation & filling, where both ease of use and sterility assurance are critical.

More information.

Product News

Process Development Simplified

Microscale bioprocess development makes a leap forward. Now, in a convenient, disposable format, the new Micro-24 MicroReactor system offers true high-throughput capability for early stage process development: clone selection, media optimization, and design space definition. With independent control of each microreactor, Micro-24 system results are easily scalable to larger bioreactor formats, dramatically decreasing process development time. The entire system is designed for ease-of-use and simple deployment in standard laboratory environments.

Features:

  • Disposable 24 well cassettes for high throughput and rapid turn-around
  • Independent control of temperature, pH, and dissolved oxygen in each well
  • Benchtop footprint for easy deployment into laboratory environments
  • Cassettes for microbial or mammalian cell culture applications

More information.

Industry's First Single-Pass TFF Technology

Pall’s new Cadence™ single-pass TFF system eliminates the need for a recirculation loop in conventional tangential flow filtration for process simplification. It enables direct flow operation with a substantial reduction in system holdup volume in order to streamline downstream processing.



 

Cadence single-pass TFF systems enable:

  • Direct coupling with other DSP process steps
  • Improved recovery capabilities (> 98 %)
  • Processing of shear-sensitive products
  • Increased capacity at reduced costs
  • Elimination of costly storage tanks
  • Reduced system hold-up volume

Cadence modules incorporate Pall’s proven T-Series cassettes with Delta regenerated cellulose membrane, which provides high flux, high selectivity, and low protein binding characteristics.

More information.

Application

Chromatography Sorbent Screening Services

Now you can accelerate the development of chromatography processes for your purification needs. Pall's Chromatography Sorbent Screening Services use 96 well filter plates with any choice of sorbent chemistries in combination with fast analytics. This Confidential service provides you with fast and secure determination of the best chromatography sorbent for each individual application. All services include a comprehensive report with detailed data to summarize the project.

Pall Chromatography Sorbent Screening Services provide:

  • High-throughput sorbent screening for bioprocessing
  • Individual choice of sorbent chemistries
  • Screening completed in two days
  • Limited sample consumption Comprehensive report

For more information email bpvision@pall.com.

Interview

Quality by Design (QbD)

Richard Francis has over 27 years experience in process development and manufacturing and has been involved in the development of many significant commercial biopharmaceutical products. Richard is Director of Francis Biopharma, a consulting company focused on facilitating biopharmaceutical product development, with specific expertise in quality by design.

What is Quality by Design

QbD is a systematic approach to the development and maturing of process and product knowledge. It facilitates the operation of a robust commercial manufacturing process consistently delivering the required quality product.

Why is QbD Important?

Knowledge is the critical deliverable. It might be derived, for example, from hundreds of small scale experiments feeding DoE (Design of Experiments) data crunching software. Such knowledge can lead to a continual improvement of pharmaceutical processes and can be considered as the design space, in which a process when operated to pre-defined process conditions will yield a product with the required attributes.

Where Can QbD be Applied?

QbD can be applied throughout all stages of process development. It allows companies developing pharmaceutical products to demonstrate process knowledge to regulatory agencies and customers. It assures these products meet quality specifications and hence clinical utility. After definition of the product characteristics, process development can focus on data generation for in depth product / process understanding. It takes the old paradigm of "the process is the product" to "the process knowledge is the product".

What Tools are Important for Implementing QbD?

QbD asks for an intensive evaluation of the effects of the process parameters on quality attributes. Knowledge generation instead of data generation is the key driver. QbD requires a rational utilization of scale down process models with analytical methods capable of measuring the defined product attributes. All process data need to be considered and reviewed in the development of a rational knowledge based understanding of the process.

What Will be the Uptake of QbD Within the Next 5 Years?

I hope that QbD becomes the hub of process knowledge generation, an integrated effort to generate process and product knowledge to support the complete product lifecycle. I hope that companies would have a passion to actually understand the processes they intend to use to manufacture the products they intend to commercialize and base their future success upon.

For further information on any of the articles within this newsletter, or to suggest topics for future editions of BioProcess Vision please contact us