Single-Use Stainless Steel BioReactors: Quality Factors for Consideration When Selecting a Suitable System


08th November 2017 | 10 AM EST | Dr Trevor Deeks, Principal and Consultant of Deeks Pharmaceutical Consulting Services, LLC |ATTEND FREE WEBINAR

Single-use (SU) systems are now in common use in pharmaceutical bioprocessing, as well as in other related technologies such as the manufacture of diagnostics and other biological products, and their popularity is increasing. Some types of SU systems have been in use for many decades now. The earliest SU systems being disposable filter cartridges that do not require a stainless steel (SS) filter housing. This present article seeks to focus in particular on SU bioreactors for cell culture and bacterial fermentation for the purpose of producing therapeutic proteins, monoclonal antibodies and vaccines. SU bioreactors are of particular value in early phase (Clinical Phases 1 and 2) GMP manufacturing. In some cases their use has now stretched through into commercial processing, albeit that the scale of operation is currently limited and in general the largest commercially available SU bioreactors are around 2000L working volume (WV). However, the small footprint that they require, and the reduction in investment needed for support services and utilities, means that the scale limitations can be overcome to a significant degree by having multiple SU bioreactors operating in parallel within a facility. The harvest from multiple bioreactors can be pooled for downstream processing, or each harvest can be processed as a separate batch, based upon considerations of the risks versus the economies of pooling.

There are many factors that must be considered when deciding whether to use SU bioreactors rather than more traditional SS systems. This article will describe the factors driving the decision-making process and how the choice might change depending upon the needs and regulatory expectations at each phase of clinical development. In particular, this article aims to examine the quality and reliability factors, which are often a low consideration in such decisions. Factors such as production scale and the need for supporting systems are also discussed with respect to their impact on quality and compliance, rather than in relation to the economic factors, which are often the decision drivers. It is important to consider such factors because they can also greatly influence actual costs, speed, reproducibility and the overall success of the process.

 

Presented by Dr Trevor Deeks, Principal and Consultant of Deeks Pharmaceutical Consulting Services, LLC

Trevor has 38 years of experience in pharmaceutical development, manufacturing, quality control and quality assurance. He is registered as an eligible QP under EC Directive and has also practiced as a registered Pharmacist in the UK. He now resides in Maryland and has his own consulting business. He has a Ph.D. in Peptide Chemistry and has extensive expertise in bioprocessing, aseptic processing and validation. He has experience of a wide range of unique and unusual biotechnology processes, including live vaccines, tissue culture products, and cell-based products.

He practiced as a QP from 1983 until 2010 in the UK and his QP experience includes commercial batch release, investigational medicinal products and “Specials”. He has established and operated Quality Systems in compliance with the European Clinical Trials Directive and with global regulatory expectations (FDA, WHO, ANVISA, etc.). He has led scale-up and technology transfer projects for large and small molecules, has managed many projects with contract manufacturing organizations, has undertaken a number of evaluations of new technologies, and has performed due diligence evaluations of such products for acquisition.

 

Sponsored by GE Healthcare

 

About GE Healthcare Life Sciences
The Life Sciences business of GE Healthcare provides a wide range of bioprocessing products and services that enable the development and manufacture of high-quality biotherapeutics and vaccines. Using our knowledge and expertise, we support our customers in increasing speed to market, while avoiding unnecessary costs and improving quality and performance in drug manufacturing.  As a provider of high-quality products, customized technical and commercial services, as well as design and construction of complete biomanufacturing solutions, we support the biopharmaceutical industry in making health visions a reality.

 

Presented by Ken Clapp, Senior Manager, Applications, Technology & Integration, GE Healthcare

Kenneth Clapp is a senior manager at GE Healthcare, focusing on applications, technology, and integration. Kenneth holds a Bachelor’s degree in biology with a specialization in subcellular biology. He received a Master’s degree in biological engineering, focused on biological control systems, mathematical modelling, and instrumentation. Early in his career, he worked as a cell culture technologist, produced antigens and antibodies in large scale, and developed hollow fiber-based bioreactors. Spanning four decades, Kenneth has worked in a variety of roles with bioprocess equipment manufacturers, including field service, sales and marketing, applied research and development, quality assurance, automation, and operations management. He has been managing bioprocessing equipment capital projects, including supply oversight, documentation and ERP integration.