Tools for Achieving Robust Process Design with Early Phase Process Development

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation,
  • Wednesday, May 20, 2015

The keys to developing biomanufacturing processes which are efficient, robust and of high quality start during the initial design stages of cell line and process development. The webinar will provide a case study and discuss how to rapidly develop customized, reliable manufacturing processes.

As a result of  the modern dominance of CHO expression systems for recombinant protein production, FUJIFILM Diosynth Biotechnologies has developed Apollo™, its own manufacturing ready CHO expression system that meets clinical and commercial requirements, to provide clients with a single source CDMO to go from gene to GMP manufacturing. The Apollo™ mammalian expression system also includes platform basal and feed media that are optimized for recombinant protein expression.

In concert with the cell line and media development efforts, FUJIFILM Diosynth Biotechnologies has streamlined its approach to early phase development that uses either the Apollo™ CHO expression system or its client’s expression system. The speaker will describe this unique approach to process and analytical development, citing specific examples of the Apollo™ platform media development and a case study on the application of its Toolbox media and feed system to improve process performance when using a client CHO cell line.

The Media and Feed Toolbox case study is a good example of how advances in media technology can change a process outcome. The case study will demonstrate how variability in complex media from the original process led to low product titer and poor product quality that jeopardized the success of the program. Fujifilm was able to apply the media and feed Toolbox to transition the process to a high performing chemically defined media. As a result, product quality was restored and product titers were twice as high as for the original process. This case study shows how a modern and robust chemically defined media system can dramatically improve process robustness and reliability in the future.


Stewart McNaull, PhD, Director, Development and Technical Services, FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

Stewart McNaull has over 16 years of experience in bioPharmaceutical process development, tech transfer, manufacturing and new technology innovation; specializing in cell culture and microbial systems. He led the Upstream Process Development group at Fujifilm Diosynth Biotechnologies for six years with prior experience managing clinical and commercial program execution in GMP manufacturing. His experience includes leading CHO mAb and microbial tech transfer and scale-up efforts and providing commercial process engineering support. Stewart has been a key contributor to the evaluation of single-use technologies at both sites and has led the implementation of these technologies into GMP manufacturing. Currently, he is charged with designing and leveraging our innovation programs to offer new capabilities and services to our industry partners.

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Who Should Attend?

R&D VPs, Directors, Managers and Department Heads of pharma and biotech companies who are responsible for cell line or process development, and/or manufacturing and looking to outsource development and manufacture of their biopharmaceutical products.

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FUJIFILM Diosynth Biotechnologies is an industry leading Biologics Contract Development and Manufacturing Organization with locations in USA and UK. With extensive experience in the development and manufacture of bioPharmaceuticals expressed in a wide array of systems, we offer a comprehensive list of services from cell line and strain development, including our proprietary pAVEway™ microbial and Apollo™ cell line systems, to process development, analytical development, clinical and commercial manufacturing. Both sites are FDA-approved for the production of commercial products. Through a strategic alliance with Piramal Healthcare we offer development and production of Antibody Drug Conjugates and over the last two years have significantly expanded our cGMP cell culture manufacturing capacity.

FUJIFILM Diosynth Biotechnologies has over 15 years of experience in the development of cell culture processes for clinical and commercial manufacturing. During this period we have executed over 50 mAb and non-mAb programs using CHO, NSO and baculovirus/insect cell expression systems. To build on our experience in developing processes using a variety of client supplied expression systems, we set out to establish a subset of best performing basal and feed media to support CHO based expression systems. This collection of commercially available and chemically defined basal and feed media is termed the ‘Media and Feed Toolbox’. We have applied the Media and Feed Toolbox to client CHO cell lines with significant success for process productivity and product quality improvement.

Our experience in cell culture development and manufacturing combined with our innovation efforts has led to an advanced cell culture offering that provides the ability to solve most bioPharmaceutical challenges.

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