Manufacturing

Preparing for Preapproval Inspection (PAI): How toTransition Operations from Early Stage to Phase 3 and Commercial Production

This podcast features: Patricio Massera, general manager of the Copenhagen facility for CMC Biologics This podcast was recorded at the 2014 BioProcess Theater which took place at the 2014 BIO International Convention, June 23-26, 2014. The BioProcess Theater, a 50-seat amphitheater located on the exhibition floor at the heart of the BioProcess Zone, provided attendees with daily, complimentary opportunities to listen, learn, and interact with leading experts as they presented, discussed and debated the latest business and scientific trends impacting…

Product Development Partnership: AERAS as a Model

This podcast features: Peter Alexander, senior director of technical operations at AERAS This podcast was recorded at the 2014 BioProcess Theater which took place at the 2014 BIO International Convention, June 23-26, 2014. The BioProcess Theater, a 50-seat amphitheater located on the exhibition floor at the heart of the BioProcess Zone, provided attendees with daily, complimentary opportunities to listen, learn, and interact with leading experts as they presented, discussed and debated the latest business and scientific trends impacting the development…

Developing a Robust and Scalable CGMP Protein Manufacture Process

This podcast features: Daniel Smith, PhD, chief scientific officer of Cobra Biologics, and Julian Hanak, commercial director of Cobra Biologics This podcast was recorded at the 2014 BioProcess Theater which took place at the 2014 BIO International Convention, June 23-26, 2014. The BioProcess Theater, a 50-seat amphitheater located on the exhibition floor at the heart of the BioProcess Zone, provided attendees with daily, complimentary opportunities to listen, learn, and interact with leading experts as they presented, discussed and debated the…

The Future of Aseptic Filling: Automated Filling Robots Coming to a Clean Room Near You

This podcast features: Gene Yoshioka, director of manufacturing at Avid Bioservices This podcast was recorded at the 2014 BioProcess Theater which took place at the 2014 BIO International Convention, June 23-26, 2014. The BioProcess Theater, a 50-seat amphitheater located on the exhibition floor at the heart of the BioProcess Zone, provided attendees with daily, complimentary opportunities to listen, learn, and interact with leading experts as they presented, discussed and debated the latest business and scientific trends impacting the development and…

CMO/CDMOs: How Technologies Are Changing Outsourcing Strategies, Services Offered, and Risks Taken

This podcast features: Moderator: Susan Dexter, principal consultant at Latham Biopharm Group Panelists Economic Trends: Rob Silber, director of supply chain/business contracts at Boehringer Ingelheim Technology Advancements: Andrew Sandford, vice president of business development at Catalent Pharma Solutions Facility Designs: Bill Reed, PhD, senior vice president of operations at Kalon Biotherapeutics Service Offerings: Mark Bamforth, president and chief executive officer at Gallus BioPharmaceuticals This podcast was recorded at the 2014 BioProcess Theater which took place at the 2014 BIO International…

The Client Experience: The Key to a CDMO’s Sustainable Future

This podcast features: Safa’a Al-Rais, senior director of venture management at Therapure Biopharma This podcast was recorded at the 2014 BioProcess Theater which took place at the 2014 BIO International Convention, June 23-26, 2014. The BioProcess Theater, a 50-seat amphitheater located on the exhibition floor at the heart of the BioProcess Zone, provided attendees with daily, complimentary opportunities to listen, learn, and interact with leading experts as they presented, discussed and debated the latest business and scientific trends impacting the…

GMP Considerations for Bioprocess Design: A CMO Perspective

This podcast features: Les Tillack, chief executive officer at PharmaSynth Pty Ltd. This podcast was recorded at the 2014 BioProcess Theater which took place at the 2014 BIO International Convention, June 23-26, 2014. The BioProcess Theater, a 50-seat amphitheater located on the exhibition floor at the heart of the BioProcess Zone, provided attendees with daily, complimentary opportunities to listen, learn, and interact with leading experts as they presented, discussed and debated the latest business and scientific trends impacting the development…