Process Scale-up, Validation and Technology Transfer for Biologics

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

WHY SHOULD YOU ATTEND?

Master Regulatory and Validation Requirements

Gain a clear understanding of global regulatory expectations for process validation and technology transfer, ensuring compliance and smoother approvals.

Apply QbD for Robust Scale-Up

Learn how to integrate Quality by Design principles into process development to achieve consistent, high-quality biologics production.

Overcome Real-World Scale-Up Challenges

Explore proven best practices, risk assessment tools, and strategies to navigate technical and regulatory hurdles during scale-up.

Streamline Technology Transfer

Acquire practical frameworks for planning, executing, and managing supplier relationships during complex technology transfers.

OUR ONLINE TRAINING EXPERIENCE INCLUDE

Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.

LEARNING OBJECTIVES

Build Quality into Biologics Processes

Learn how to design manufacturing processes where quality is embedded from development through commercial production

Apply QbD Principles Effectively

Use Quality by Design to guide scale-up, validation, and technology transfer for consistent, high-quality outcomes

Navigate Regulatory and Change Management

Understand global regulatory requirements and apply strategies to manage process changes without delays

Ensure Smooth Technology Transfers

Work seamlessly with suppliers and partners to plan, execute, and troubleshoot technology transfer projects

WHO IS THIS TRAINING FOR?

Designed for professionals who want to enhance their expertise and advance their careers

Process Engineers and Scientists

MSAT

USP/DSP

Process Validation

KEY TOPICS

Scale-up of bioprocesses

QbD principles during process development & scale-up

Process validation & managing regulatory changes

TRAINER

Dr. Sam Denby

Managing Director, Biofrey

Managing Partner, BioFrey, United Kingdom Dr. Denby is a Biochemical Engineer with over 20 years of experience in the bioprocess industry. He received his Engineering Doctorate in Biochemical Engineering and Bioprocess Leadership from University College London. Sam began his career in the process development group of Cambridge Antibody technology and was engaged in multiple technology development and transfer projects throughout the acquisition by AstraZeneca and merger with Medimmune. Sam subsequently joined Oxford BioMedica and was instrumental in establishing many of the process development Philosophies still in use today. Between 2010 and 2016, Sam was a technical consultant for Becton Dickinson’s Cell culture media products with responsibility for Europe, the Middle East and Africa and was involved in a number of key projects for clients with biologic products generating annual revenues of up to $16bn. Sam founded BioFrey in 2017 and has revolutionised the availability of extractables data and change notification practices around single-use systems facilitating the uptake of these systems that have proven crucial in the ongoing pandemic. Sam is currently providing CMC consultancy for a late-stage monoclonal antibody.

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Sneak Peek

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