Dr. Gilbert Tumambac, Pall Biotech - Qepler Summits And Conferences

Dr. Gilbert Tumambac

Sr. Principal Scientist
Pall Biotech
New York, USA
Pall Biotech reduces your costs while increasing efficiency and quality for today’s development of sensitive biologic products.

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.

Related Sessions:

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
BLOCK:
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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