Biomanufacturing experts share strategies to maximize efficiencies and cost savings across your manufacturing network through implementation of disruptive technologies, operational excellence and new facility concepts. Learn how to develop your manufacturing infrastructure so you can remain flexible to the production needs of a diverse pipeline of novel biologic molecules in a multiproduct environment.
A Life Cycle Approach to Managing Risk throughout the Design, Qualification, and Operation of Manufacturing Systems
Ghada Haddad, Director, Engineering, Sterile & Validation CoE, Merck & Co.
Full Presentation: 9:15 am, Tues. Oct. 27, 2015
Listen as Haddad describes the risk management process and risk assessment to focus the design and specification development for a product. She also explains how quality risk management works with QbD.
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Therapeutic Protein Production On-Demand
Govind Rao, PhD, Professor and Director, Center for Advanced Sensor Technology, University of Maryland, Baltimore County
Full Presentation: 11:15 am, Tues. Oct. 27, 2015
Govind Rao explains how this briefcase biomanufacturing concept could work to bring therapeutics to a site on-demand. Using reconstituted cell extract with CDMA to the target protein, and producing product within several hours on a small scale.
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Innovation Development within a Strategic Supplier Program
Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global Process Owner, Biogen
Full Presentation: 11:20 am, Weds. Oct. 28, 2015
Dave Kolwyck describes how a strategic supplier program can benefit biopharmaceutical manufacturers and create innovative tools to manufacture biopharmaceuticals faster, creating a true supplier and manufacturer partnership.
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Condensed Playbook for Continued Process Verification (CPV)
Marcus Boyer, Associate Director of Process Life-cycle Management, Bristol-Myers Squibb
Full Presentation: 1:45 pm, Weds. Oct. 28, 2015
The continued process verification (CPV) playbook was created by the BioPhorum Operations Group (BPOG), Boyer describes how the playbook came about and how biopharmaceutical manufacturers can use it in their process validation and ongoing quality control efforts.
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Closed Processing and Sanitizing Temporary Openings
Kavita Ramalingam Iyer, Senior Specialist, Global Regulatory Affairs, Vaccine-CMC, Merck Sharp & Dohme Corp.
Full Presentation: 8:45 am, Thurs. Oct. 29, 2015
Hear from Dr. Iyer on her work with the BioPhorum Operations Group (BPOG) and the Biomanufacturing, Training and Education Center (BTEC) on closed systems in manufacturing biopharmaceuticals. With new technologies, isolation of biomanufacturing can exist in a controlled, non-classified space without posing contamination risk. The purpose of the collaboration between BPOG and BTEC is to demonstrate the restoration of previously closed systems back to closed through effective sanitization using chemical agents rather than steam.
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View the complete Manufacturing Strategy speaker line-up.