Home WebinarsDe-Risking Tech Transfer: Strategies for Clinical-Stage Biotechs and Biopharmas

De-Risking Tech Transfer: Strategies for Clinical-Stage Biotechs and Biopharmas

WEBINAR

The biotech market faces challenges such as increasing competition, evolving regulatory requirements, and the need for rapid innovation in drug development. In response, as a CDMO, we provide comprehensive solutions that integrate proven technologies and regulatory guidance to support clients. Process fitting and optimization examples include improvements that enhance product quality, boost performance, and reduce costs.

To secure comparability despite changes, a robust strategy is essential, involving thorough analytical testing and proactive risk assessment. By focusing on quality and compliance, we ensure that changes do not compromise the integrity or efficacy of the final product.

In this webinar, you will learn:

The importance of the initial risk assessment to ensure tech transfer success
To define the appropriate process strategy based on the client's global CMC strategy
To set appropriate control points on quality attributes in order to anticipate comparability risk

Speakers

Marie Cecille

{hcompany}

Technical Leader

Marie Cecille has a master’s degree in biotechnology and bioengineering. After spending a few years as a consultant on the management of products and processes within the pharmaceutical industry, she joined {hcompany} in 2021 as a technical leader. Since then, she has actively helped CTDMO customers to succeed in the technical strategy of their clinical projects, including process and analytical development, GMP activities, tech transfer, and CMC compliance.

Magali Toueille, Ph.D.

{hcompany}

Downstream Process Development Manager

Magali Toueille, Ph.D. is a downstream process development manager at our End-to-End Biodevelopment Center Martillac, France. She leads downstream process development activities for client projects as well as internal projects aimed at continuously optimizing the performance of our developments. Magali holds a Ph.D. in Biological Science.

Magali has held several research positions in France and Switzerland, and she was a senior manager, chromatography applications at Pall Life Sciences. She also held the position of head of downstream process development and preclinical production at Genethon for 5 years. Magali holds a Ph.D. in biological science.