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
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.
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.
Who Should Attend?
VPs, Directors, Managers and Department Heads of pharma and biotech companies who are currently working with or considering single use technologies, or outsourcing to CMOs who can offer manufacturing solutions using these technologies.
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™ and CHO cell line systems, to process development, analytical development, clinical and commercial manufacturing. Both sites are FDA-approved for the production of commercial products. In October 2012 we announced a strategic alliance with Piramal Healthcare for the production of Antibody Drug Conjugates and are significantly expanding our mammalian cell culture facilities with the addition of new cell line development services and additional cGMP manufacturing capacity.