Contaminants such as viruses, bacteria, and fungi can enter the bioreactor during the biopharmaceutical manufacturing process. Due to this potential risk, a comprehensive biosafety testing strategy for Unprocessed Bulk (UPB) materials can help identify, take quick corrective actions to prevent future occurrences, and minimize costly delays in your pipeline.

Join us for a webinar to discuss unprocessed bulk testing approaches, logistics, and regulatory considerations to reduce the risk of contamination, including:

Common test methods used to assess UPB Biosafety, including Mycoplasma, IVAA, MMV PCR and TEM.
Testing strategies and turnaround times, including a rapid, 21-day approach.
Use of risk assessments to determine the best testing strategy.
Phase-appropriate validation considerations for early clinical trial stages through late stage and BLA filings.
Logistics & execution, including sample submission, online ordering, raw data availability, Certificates of Analysis and more.

Presenters:

	Stanley Prince Senior Scientific Advisor, Biologics Eurofins BioPharma Product Testing
As a Senior Scientific Advisor for Eurofins BioPharma Product Testing, Mr. Prince provides technical and commercial support for GMP Biosafety services for large molecule and cell and gene therapy projects, helping clients to navigate specialized testing needs. Mr. Prince has worked for large molecule and cell and gene therapy CRO’s his entire career, bringing over 17 years of experience to his role at Eurofins. He earned a B.S. degree in life sciences from Penn State University and an M.B.A. from Alvernia University.
	Jonathan Talmadge Group Leader, Project Management Eurofins BioPharma Product Testing
As a Project Manager for Eurofins BioPharma Product Testing, Mr. Talmadge supports Biosafety, Cell Banking and Viral Clearance services specifically. With 6 years of experience supporting these areas of testing, Mr. Talmadge is an integral member of the team in developing, implementing, and maintaining the Unprocessed Bulk Lot Release Testing process for Eurofins BPT. In addition, Mr. Talmadge supervises a team of Project Managers that specifically support these testing areas. Mr. Talmadge studied Business Administration at the University of North Carolina State.

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Join us for a webinar to discuss unprocessed bulk testing approaches, logistics, and regulatory considerations to reduce the risk of contamination, including:

Common test methods used to assess UPB Biosafety, including Mycoplasma, IVAA, MMV PCR and TEM.
Testing strategies and turnaround times, including a rapid, 21-day approach.
Use of risk assessments to determine the best testing strategy.
Phase-appropriate validation considerations for early clinical trial stages through late stage and BLA filings.
Logistics & execution, including sample submission, online ordering, raw data availability, Certificates of Analysis and more.

Presenters:

	Stanley Prince Senior Scientific Advisor, Biologics Eurofins BioPharma Product Testing
As a Senior Scientific Advisor for Eurofins BioPharma Product Testing, Mr. Prince provides technical and commercial support for GMP Biosafety services for large molecule and cell and gene therapy projects, helping clients to navigate specialized testing needs. Mr. Prince has worked for large molecule and cell and gene therapy CRO’s his entire career, bringing over 17 years of experience to his role at Eurofins. He earned a B.S. degree in life sciences from Penn State University and an M.B.A. from Alvernia University.
	Jonathan Talmadge Group Leader, Project Management Eurofins BioPharma Product Testing
As a Project Manager for Eurofins BioPharma Product Testing, Mr. Talmadge supports Biosafety, Cell Banking and Viral Clearance services specifically. With 6 years of experience supporting these areas of testing, Mr. Talmadge is an integral member of the team in developing, implementing, and maintaining the Unprocessed Bulk Lot Release Testing process for Eurofins BPT. In addition, Mr. Talmadge supervises a team of Project Managers that specifically support these testing areas. Mr. Talmadge studied Business Administration at the University of North Carolina State.

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