Overview

The seminar will focus around three relevant themes for bioprocess development on single-use bioreactors applied in the production of viral vectors: predictive performance, robustness and safety.

An initial overview of the current landscape developments in the BioPharma Industry highlights that bioprocesses should remain flexible enough in order to accommodate intensification and reduce time-to-market. With this in mind we will discuss key aspects in the improvement of bioreactor performance, particularly for viral vector production. Additionally, processes must remain sufficiently robust to ensure standard yield output with defined quality attributes, while remaining safe for both the operators and processes.

As processes increasingly require a high level of compliance with regulatory directives, especially regarding novel approaches for viral vector production and other advanced therapies, safety is a vital aspect when defining upstream processes. All these aspects should be taken into consideration while maintaining a smooth transition from early stage process development to commercial manufacturing scales.

The BIOSTAT STR® system and Flexsafe® STR consumables offer a total solution approach to deal with these challenges, and we invite the participants to raise questions about these and any other relevant aspects for Gene Therapy.

Speakers

Lara Nascimento-Brooks

Lara is a biotechnology and bioprocess engineer who graduated from the Federal University of Parana (UFPR) in Brazil, and the Technical University of Compiegne (UTC) in France. She has over 10 years of industry experience within companies such as Sanofi, Merck Millipore, Octapharma and most recently at GSK within the Cell & Gene Therapy department.

In her current role, in Sartorius Stedim Biotech, as a market entry strategy manager, she focuses on strategies for the implementation and promotion of new cutting-edge solutions and technologies, focusing on viral based therapies. Prior to that Lara acted as product manager for the large scale bioreactor consumables Flexsafe STR.

Dr Franziska Bollmann

Franziska is a biochemist and holds a PhD degree in cell biology. Additionally, she is a certified quality and project manager with more than 10 years of work experience.
Currently, she is a process technology consultant at Sartorius Stedim Biotech, Germany, where she is responsible for providing scientific consultation, managing customer collaborations and identifying the best solutions for the virus-based therapeutics.

In her previous role at Sartorius, as a virus scientist in the Regenerative Medicine department, she was responsible for lentivirus process development (USP and DSP), new product development focussing on viral vector applications and management of cross-functional and global project teams for three years.

Before joining Sartorius, Franziska worked as a research associate for the CRO Evotec, where she led drug discovery projects for international clients. In this role, she was responsible for target identification and lead discovery, assay development and lentivirus production.

Time

09:00—10:00 GMT.

Format

A one-hour online session: 40 minutes presentation + 20 minutes Q&A.

• Part 1: Enabling increased performance, robustness and safety in single-use bioreactors (15 min)
• Part 2: Viral vector process workflow with single-use processing and predictive control (25 min)
• Part 3: Q&A (20 min)

Software

The presentation will be delivered via GoToWebinar®. 
Check system requirements.

You are advised to join the webinar at least ten minutes before the scheduled start time, to allow for your computer to connect.