Dr. Gilbert Tumambac

Sr. Principal Scientist
Pall Biotech
New York, USA

Gilbert Tumambac, Ph.D. is a Sr. Principal Scientist in the Regulatory and Validation group at Pall Biotech (Port Washington, NY).

He has over 13 years of industry experience which includes 5 years with Merck & Co., Inc. working on analytical method development, validation and impurity identification, and over 8 years with Pall where he currently serves as one of the E&L SMEs supporting single-use and continuous processing technology.

He has a PhD in Organic Chemistry from Georgetown University in Washington, DC.

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Extractables & Leachables
Summit 2019

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.

15 Oct 2019
Berlin, DE
Pharma

Day 2: Wednesday, 16 October 2019

CASE STUDY: Adoption of standardized extractables datasets for single-use system qualification and risk assessment.

Implementation of USP <665> and alignment with BPOG extractables protocol
Insights from the execution of both the BPOG and USP <665> extractables protocols on various single-use components (biocontainer, filter, sterile connector, tubing)
Examples of extractables datasets generated per BPOG and USP <665> extractables protocols
Case studies illustrating how component extractables data are applied for risk assessment of potential leachables from single-use system
Toxicological risk assessment of potential leachables from SUS

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Dr. Gilbert Tumambac