Wednesday, October 2, 2013

Single-Use Technologies in Cell Therapy

Today, we feature an excerpt from BioProcess International. Dominic Clarke's article Single-Use Technologies in Cell Therapy: Lessons Learned was featured in the March 2013 Supplement of BioProcess International.

 Single-use (also referred to as disposable) technologies and systems are those intended for one-time use. They generally consist of plastic polymers that include but are not limited to polyethylene (PE), ethylene vinyl acetate (EVA), polyvinyl chloride (PVC), polypropylene (PP), and polycarbonate (PC). Disposables originated in the early 1950s by Fenwal Laboratories (now Fenwal Blood Technologies, a Fresenius Kabi Company) in the form of plastic blood bags. Since that time, SUTs have grown into an extensive range of
products: from standard Petri dishes and culture flasks routinely used in cell culture laboratories to large-scale cell stacks and rocker bags (Figure 1) and now even immense 3,000-L culture bags for commercial-scale production levels (1). Although early uses were dedicated to regulated (medical device) blood-transfusion applications, the latest advances can be attributed to wide-scale use and adoption into biopharmaceutical production (2). Such increased use and adoption by the industry has been a driving force for improving overall quality standards for SUTs.

Using disposable technology for cell therapy development, manufacturing, and clinical application is standard practice. Cell therapy experts are very familiar with SUTs. But the hybrid of disciplines and applications making up the industry has in many ways created some confusion when it comes to the next generation of considerably different cell therapies currently in clinical development.

Consider, for instance, a group working on an exciting new therapy originating from a hospital/clinical setting. Such personnel are well versed in working within a clinical environment mainly using regulated (medical device) SUTs. Now consider a completely different therapy being developed by a research laboratory at a university level, which in turn eventually spins off into a new startup cell therapy company. Those personnel are adept at working in a nonregulated environment with standard R&D labware. As such, the
knowledge and perceived requirements for SUTs for clinical scale-up and product manufacturing is likely to be noticeably different. In both cases, small-scale development using established single-use technologies and systems introduced initially will be acceptable. But it’s likely that neither will have appropriate technology and necessary documentation to support manufacturing requirements in later
clinical phases.

With more cell therapy products entering phase 3 clinical trials and commercialization, it is imperative that the biopharmaceutical industry recognize not only the opportunities presented with SUTs, but more important, the knowledge gaps and potential pitfalls. It can be devastating to reach a point when a product is ready to enter a phase 3 clinical trial (or, worse, commercialization) and have to make a change to a single-use cell growth/expansion bag or storage container because another technology was discontinued or altered. Given the vast availability of alternative (similar) SUTs, making a change doesn’t seem too daunting a task until you notice,
for example, that your cells don’t behave the same way with the new film, or the bags don’t meet the same storage requirements. That situation could significantly delay timelines or even destroy potential product.

Fortunately, manufacturers already have learned from encounters with such issues. Some have incorporated single-use platforms for producing new commercialized drugs. Along with this, the SUT industry suppliers and service providers of the BioProcess Systems Alliance (BPSA, help establish guidance and best practices for implementing single-use in biomanufacturing processes (2). The cell therapy industry can benefit from using current resources and developing a better understanding of the impacts of disposable systems on manufacturing.

Read the rest of the article here. 

If you'd like to find out more about single use technologies and cell therapy bioprocessing, Richard Eglen, Ph.D., Vice President and General Manager, Corning Incorporated, will be on hand at the Cell Therapy Bioprocessing Event to present the technology workshop Optimization of Single-Use Technologies in Cell Therapy.  For more information on this session and the rest of the program, download the agenda.  Would you like to join us in Bathesda, Maryland this coming October 21-22? As a reader of this blog, when you register to join us and mention promo code BX13188JP20, you're eligible to save 20% off the standard rate! 

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