Andrew Brewer, Genentech/ Roche - Qepler Summits And Conferences

Andrew Brewer

Principal Engineer, Global Biologics MSAT
Genentech/ Roche
San Francisco, USA
As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.

Andy has been with Genentech/ Roche for 20 years, and has over twenty five years of engineering experience in the pharmaceutical and biotechnology industries. Over his career, he has specialized in sanitary process design, Clean-in-Place technologies, cleaning and sterilization processes, and on microbial contamination control.

Andy currently leads a global initiative to align the Roche biologics network on setting cleaning acceptance criteria using Health-Based Limits such as ADE (Acceptable Daily Exposure). Application of ADE for highly potent biologics challenges current analytical capabilities, and Roche has been actively working towards solutions.

Related Sessions:

2nd Annual Highly Potent APIs
Summit 2020

Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.
  • 19 Feb 2020
  • Prague, CZ
  • Pharma
Day 2: Thursday, 20 February 2020
CASE STUDY: Challenges of introducing an ADC into a multi-purpose Drug Product facility.
  • Cross Contamination Control Concept.
  • Cleaning Validation and Monitoring Strategy.
  • Deriving most stringent Acceptance criteria.
  • Challenges in production routine.
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