Drug Digest: Evaluating Aseptic Processing and Manufacturing

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, and Feliza Mirasol, Science Editor, Pharmaceutical Technology Group, interview experts about aseptic processing and manufacturing. During the discussion, industry experts will evaluate the importance of aseptic processing and manufacturing, highlighting the challenges impacting industry, the intricacies of the regulatory landscape, the importance of understanding nuances between products and processes, the necessity of addressing QC/QA early on, best practices to ensure aseptic sterility, and potential future trends.

Interviews featuring

Maik W. Jornitz, Founder and Principal Consultant, BioProcess Resources

Maik W. Jornitz, founder and principal consultant of BioProcess Resources, is a 35-year veteran of the industry. He is highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing-grade filtration and filter integrity testing. He has published multiple books, book chapters and over 100 scientific papers on various bioprocessing and facility design topics. He is the former chair of the Parenteral Drug Association (PDA) board of directors and science advisory board, and member of multiple PDA Task Forces, including the European Union Annex I response team. He is board member and senior business and strategy advisor of DIANT Pharma. As a faculty member of various training activities, including PDA Training and Research Institute, he trains members of the industry and regulatory authorities frequently. In his previous roles, he was the CEO of G-CON for 10 years, he worked 26 years for Sartorius, with his last role being the senior vice-president for Global Product and Marketing Management Bioprocess. He received his Master of Engineering in Bioengineering at the University of Applied Sciences in Hamburg, Germany, and accomplished the Program for Executive Development at IMD Business School in Lausanne, Switzerland.

Dan Strange, PhD, Chief Technology Officer, Cellular Origins

Dan Strange has been working at the intersection of engineering and biology for almost 15 years, and he is an inventor on 20 patents. After completing a PhD in regenerative medicine at the University of Cambridge, he moved to TTP where he developed complex drug delivery devices. He was instrumental in the creation of multiple technology platforms successfully licensed to large pharma in deals worth over $100 million. For the past four years, Strange has focused on cell therapy manufacturing equipment. Strange is an active member of various automation working groups and was a reviewer on the Alliance for Regenerative Medicines A-Cell report on cell therapy manufacturing.

Sponsors

This episode of Drug Digest is sponsored by:

• Kindeva Drug Delivery
• Veltek Associates

About Drug Digest

Drug Digest is a tech talk video series with the Pharmaceutical Technology® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Upcoming episodes

• September 2024: Small Molecule APIs, Excipients, and Formulation
• October 2024: Automating Process Development
• November 2024: Solid Dosage Drug Development and Manufacturing