Did you know that most cell substrates that are the source for bio-pharma products today originate from research labs at universities? Since these source cells are not as extensively controlled to the level of scrutiny of government regulators, it is the drug sponsor’s responsibility to control, characterize, and document these activities.
Contamination of cell or viral banks, and/or raw materials (i.e., culture medium) can be devastating to your program resulting in millions of dollar in losses and huge time commitments for restoration. Equally devastating is the catastrophic loss of cell or viral banks when stored in a single facility that experiences a fire, earthquake, or any other calamity. This too can cause resulting losses that runs into millions of dollar. For a small bio-pharma firm this can mean the difference between living another day or not – literally.
This program by expert speaker Benjamin Del Tito will share knowledge on how you can identify, control and protect the critical parts, materials and processes in the making of biologics products. Further, it will give you guidance to understand the compliance requirements for the ICH and FDA, and outline the regulatory expectations. Plus, you’ll get common technical documents for reference.
Who should attend
At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.
- Dr. David Lim
Ben joined Biologics Consulting Group, Inc. in March 2015 as a Senior Consultant (Quality & Regulatory Affairs) with thirty-plus years of experience in both large pharmaceutical and small to mid-sized biotechnology companies specializing in a range of products from protein therapeutics to vaccines to diagnostics. His career has focused on the areas of analytical development, quality control, pre-clinical assay development and validation, quality assurance, and regulatory affairs. He...
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