BioProcess International | Cell & Gene Therapy Manufacturing & Commercialization – Asia

FUJIFILM Diosynth Biotechnologies is delighted to be presenting at BioProcess International | Cell & Gene Therapy Manufacturing & Commercialization – Asia Webinar Series April 11-14, 2022.

Please Join Us:

APRIL 11, 2022 – Cell Culture & Upstream Processing
10am JST / 3am CEST / 2am BST / 9pm EDT

Sharyn Farnsworth, Senior Principal Scientist & Group Leader, Upstream Process Development-Cell Culture Team
FUJIFILM Diosynth Biotechnologies, North Carolina is presenting Scaling to 20,000-L Stainless Steel Bioreactors Using Single-Use Technologies: A Case Study

• As current global capacity is struggling to meet market demands new approaches and methodologies are making bold moves and emerging to fill the gap and deliver larger scale manufacturing capacities at ever increasing rates. How does the process development function leverage single-use capabilities to develop process to be transferred into large scale stainless steel bioreactors and further expand manufacturing possibilities?

APRIL 12, 2022 – Downstream Processing & Cell Therapy
10am JST / 3am CEST / 2am BST / 9pm EDT

Charles Heise, Senior Staff Scientist, Bioprocessing Strategy & Development Group, FUJIFILM Diosynth Biotechnologies, UK is presenting on MaruXTM: A Continuous Process Platform for Manufacturing Monoclonal Antibodies

• Continuous manufacturing provides a solution for uncertainty in capacity as drug candidates progress through clinical development to commercial supply. We present a case study describing the production of a monoclonal antibody using a single-use flowpath, 500 L scale process in a non-GMP pilot facility, which is a forerunner to the construction of a continuous GMP manufacturing facility. Using our proprietary ApolloXTM high-biomass ‘perfusion ready’ cell line, combined with a commercially available single-use bioreactor operated in perfusion mode and our proprietary SymphonXTM liquid handling systems, which are used for point-of-use buffer dilution and multiple chromatography steps in a connected, intensified downstream process, we were able to process ~1 kg mAb/day.

APRIL 13, 2022 – Cell & Gene Therapy
10am JST / 3am CEST / 2am BST / 9pm EDT

Hung X. Nguyen, PhD, Manager, Program Design (Advanced Therapies), FUJIFILM Diosynth Technologies, North Carolina is presenting on Development of an AAV Manufacturing Platform to Streamline Path Toward Clinics and Commercialization

• Cell and Gene Therapies continue to offer exciting avenues as curative therapies for unmet patient needs in the ultra-rare, rare, and beyond rare clinical indications. To serve these unmet needs, cell and gene therapy companies are developing multiple products that are expected to rapidly advance from pre-clinical stages to clinical trials.
• In order to successfully move from the lab to the clinic in a timely, predictable manner while maintaining the highest product quality and safety, companies must begin by developing robust, scalable, reproducible manufacturing processes. Leveraging a manufacturing platform can help expedite the critical path for clinical development and commercialization.

This presentation will review the key challenges companies face and illustrate how FUJIFILM Diosynth Biotechnologies is helping clients overcome them, including:

• Access to an AAV manufacturing platform which includes a fully characterized, suspension adapted, clonal HEK293 cGMP cell line together with research and cGMP-grade Rep/Cap, Helper, and GOI (backbone) plasmids to accelerate early process development.
• Comprehensive panel of analytical methods to support phase-appropriate product characterization and batch release testing.
• Access to an end-to-end service offering for drug substance and drug product manufacture and an integrated manufacturing network which can support process scale up, with the flexibility to meet clinical and commercial product demand.

This webinar series is free to attend. Click here to register