Achieving Optimal Performance From Single Use Platforms: Elegant Process Design To Achieve Efficient and Economic Operational Flexibility in Multi-product GMP Facilities

Fujifilm Diosynth Biotechnologies has an established and successful history of supplying both clinical and commercial cell culture derived human therapeutics using stainless steel bioreactor platforms.

Recent need for rapid cell culture capacity expansion at their US and UK development and manufacturing sites to support customer supply demands has led the company to develop and implement single use platforms.

During this webinar, the speakers will discuss how the company has provided manufacturing flexibility under accelerated timelines on a cost-effective basis and how they compared process and product quality data for single use systems vs. stainless steel reactors, critical factors to consider when selecting the elements of the final (1000L) manufacturing train.

The speakers will describe the quality and regulatory points to consider, as well as the economic factors that supported and justified their expansion, and the design basis for “all” single use manufacturing processes at their sites that exploit the single use concept from ‘vial thaw through to bulk monoclonal antibody drug substance’.

The keys to maximizing the investment in a cGMP cell culture manufacturing facility and achieving operational benefits start during process development and initial process design. The featured case study will examine:

• How Fujifilm Diosynth Biotechnologies’ cell line development and upstream and downstream development platforms were modified and optimized to support efficient process definition and effective technology transfer to fully exploit single use bioprocess technologies
• How upfront development of a robust single use process platform streamlines manufacturing operations and provides advantages in technology transfer via elegant process design
• How these advantages in operational robustness and process transfer efficiency allow for rapid process portability to enable manufacturing flexibility on a global scale

Speakers

Stewart McNaull, Section Leader, Upstream Process Development, Fujifilm Diosynth Biotechnologies, RTP, NC, USA

Dr. McNaull has over 14 years of experience in bioPharmaceutical process development, engineering and manufacturing; specializing in mammalian and insect cell culture and microbial fermentation development and manufacturing. His experience includes 11 years at Fujifilm Diosynth Biotechnologies where he heads the Upstream Process Development group with a staff of 20 Scientists specializing in process development and innovation of new technologies. Previously he managed three GMP microbial fermentation manufacturing areas including commercial product release. Experience also includes leading CHO mAb tech transfer efforts and providing downstream process engineering support for commercial process start up. Stewart continues to be a key contributor to the evaluation and implementation of single-use technologies at Fujifilm Diosynth Biotechnologies including heading up the 1000L SUB GMP expansion project on site. Stewart also has experience in process validation, manufacturing technical support, centrifugation and filtration technologies, manufacturing scale chromatography column packing, nanofiltration, and bioreactor scale-up and tech transfer to manufacturing. Stewart received his doctorate in Chemical Engineering from the Georgia Institute of Technology with an emphasis on bioengineering.

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Bo Kara, Director of Science & Technology, Fujifilm Diosynth Biotechnologies, Billingham, UK

Bo leads the Science and Technology innovation activities at Fujifilm Diosynth Biotechnologies in Billingham, UK. He has over 25 years’ experience in the development, validation and commercialisation (CMC) of biologics drug substance processes for clinical manufacture using both mammalian and microbial manufacturing platforms. He has published widely and is primary inventor on a range of process/expression patents. He has developed a keen understanding of the technical, regulatory and commercial issues faced at each stage of the development of manufacturing processes for bioPharmaceuticals. Prior to joining Fujifilm Diosynth Biotechnologies (previously Avecia Biologics) in August 2000, Bo Kara was Team Leader, Biotherapeutic Process Development and Technology Transfer at AstraZeneca Pharmaceuticals, UK for both microbial and cell culture derived biotherapeutics.

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