Plenary Keynote Sessions

MONDAY, AUGUST 14, 2023 | 4:20-5:30 PM

Current Challenges in Bioprocessing
Glen R Bolton, PhD, Executive Director, Late Stage Bioprocess Development, Amgen Inc.

Novel therapies and technologies are emerging to meet the needs of patients; however, the manufacturing of biopharmaceuticals remains a complex and challenging process. As demand for biopharmaceuticals grows, the industry faces new challenges in terms of scalability, cost, and process robustness. The implementation of innovative technologies to improve process efficiency and the importance of process control and data analytics in ensuring process robustness are key levers to meet these challenges.

Commercializing Gene Therapies – The Combined Power of Patient Advocacy and Cost-Effective Manufacturing
Rachel Salzman, DVM, Founder, The Stop ALD Foundation & Global Head, Corporate Strategy, Armatus Bio

There are only a very small handful of FDA-approved gene therapies. This presentation will examine the development of an FDA-approved gene therapy where patient advocacy played a critical role resulting in the first-ever clinical use of a lentiviral vector. Although manufacturing continues to represent a significant challenge throughout the entire R&D journey, there are opportunities for advocacy and manufacturing communities to seek alignment and combine their collective powers to achieve the common goal of increasing patient access to transformative medicines.

WEDNESDAY, AUGUST 16, 2023 | 3:50-5:00 PM

Current and Future Trends in Biomanufacturing of New Modalities
Konstantin B. Konstantinov, PhD, CTO, Codiak Biosciences

Using exosomes as an example, this presentation examines the current and future trends in biomanufacturing, and the technologies needed to manufacture emerging modalities at scale. Traditional biomanufacturing methods do not provide the industrialized, commercially scalable, highly efficient and reproducible manufacturing process essential for this new class of biotherapeutics– so we built it from the ground up.

The Digitalization of Biomanufacturing
Richard D. Braatz, PhD, Edwin R. Gilliland Professor, Chemical Engineering, Massachusetts Institute of Technology

A fully instrumented testbed is described for the end-to-end integrated and continuous manufacturing of monoclonal antibodies. The testbed consists of parallel bioreactors, simulated moving bed chromatography systems for capture and polishing, bespoke viral inactivation, and a MAST auto-sampling system. Experimental results are compared with a digital twin for continuous runs lasting 30 to 60 days each, which include variations in metabolites and glycosylation profiles in designed experiments. The increased consistency in the glycosylation profile of the monoclonal antibodies being produced is quantified when going from batch to semi-batch to perfusion mode, and when moving from start-up to quasi-steady conditions.

Richard D. Braatz, PhD, Edwin R. Gilliland Professor, Chemical Engineering, Massachusetts Institute of Technology
Dr. Richard D. Braatz is the Edwin R. Gilliland Professor at the Massachusetts Institute of Technology (MIT). He leads the modeling, control, and systems activities in many biopharmaceutical manufacturing efforts at MIT, including for vaccines, gene therapy, and monoclonal antibodies. Most activities are in automated process development workflows and modeling, design, and control of fully automated modular manufacturing unit operations and end-to-end systems, which are experimentally validated. He has consulted or collaborated with more than 25 companies including Novartis, Pfizer, Merck, Biogen, Sanofi, and Amgen. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Separation Division Innovation Award, the AIChE Excellence in Process Development Research Award, the Research Collaboration Award from the Council for Chemical Research, and the IEEE Control Systems Society Transition to Practice Award. He is a member of the National Academy of Engineering.

Konstantin B. Konstantinov, PhD, CTO, Codiak Biosciences
Before joining Codiak, Konstantin Konstantinov was responsible for the late-stage bioprocess and technology development at Sanofi’s Boston Hub, including all functions, from cell banking to fill/finish/lyophilization. Prior to Sanofi, Dr. Konstantinov worked for Bayer in Berkeley, California for 14 years, advancing to the position of Head of Process Sciences. He has published 60 peer-reviewed papers and has more than 15 patents and patent applications. During the last 23 years, Dr. Konstantinov has worked on the development and commercialization of various products, including monoclonal antibodies, blood factors and enzymes expressed in mammalian cells. Most recently, he has pioneered the development of an end-to-end integrated continuous biomanufacturing platform, which is becoming a strategic technological trend for the biomanufacturing industry worldwide. Dr. Konstantinov received his PhD in Biochemical Engineering from Osaka University, Japan, which was followed by a post-doctoral assignment at DuPont and the University of Delaware. He is a member of the board of directors for Repligen.

Rachel Salzman, DVM, Founder, The Stop ALD Foundation & Global Head, Corporate Strategy, Armatus Bio
Longstanding advocate for patients, families, and caregivers impacted by ALD and AMN with experience advancing therapies for these conditions. Dr. Rachel Salzman is a passionate advocate for advancing therapies where novel platforms such as genetic and cellular therapies hold promise. Dr. Salzman co-founded SwanBio Therapeutics in 2017, after serving as a leadership member of The Stop ALD Foundation since 2001. For over 15 years she has provided drug development advice to biopharmaceutical executives working in the rare disease space where complex biological and business issues intersect with serious unmet medical need. The Stop ALD Foundation is a non-profit Medical Research Organization dedicated to employing entrepreneurial approaches and innovative methodology towards effective therapies, cures, and prevention of X-linked adrenoleukodystrophy (ALD), an often-fatal neurodegenerative disease. Dr. Salzman received a DVM (Doctor of Veterinary Medicine) from Oklahoma State University and a BS in Animal Science from Rutgers University.