Amandine Biehler

While cell culture media products play a critical role in the production of many types of therapeutics, there were no specific regulations or GMP certifications governing their use.
• Historically, cell culture media producers used ISO 9001, ISO 13485, and 21 CFR Part 820 to demonstrate product quality and consistency.
• A review of existing standards (ANSI, NSF, ICH, CFR, IPEC-PQG) revealed they were not applicable to cell culture media production processes.
• Merck KGaA, Darmstadt, Germany collaborated with EXCiPACT and industry experts to create a GMP standard for cell culture media, applying the EXCiPACT GMP excipient standard to pharmaceutical auxiliary materials (PAMs), which include cell culture media.

Robust commercial scale bioprocessing workflows must be established along with strategies for sterility assurance during the production of allogeneic products.
Bioprocessing considerations include:
• Establishing a robust process
• Ensuring process compatibility
• Creating the sampling plan
• Planning for media production

Sterility assurance considerations include:
• Using GMP materials
• Qualifying raw materials
• Adopting closed processing
• Performing aseptic process simulations
• Ensuring proper sterile filtration
• Understanding extractables, leachables, and particulates

The AAV vector manufacturing process involves cell lysis and nuclease treatment. Advanced techniques, such as using high salt concentration and a salt-tolerant endonuclease, can enhance vector titer and infectivity. Additionally, the development of a non-animal origin, salt-tolerant Benzonase® endonuclease has shown significant impact on AAV5 capsid titers and AAV2 vector infectivity.

In this webinar, you will learn about:
• Optimizing the CLD process for stable, high-performing perfusion clones.
• Incorporating perfusion scale-down models into your CLD workflow.
• Using Mobius® Breez for final clone selection and cost-effective perfusion process development.
• Importance of using the right media for cell line expansion and production during CLD.

In this webinar, you will learn:
• Key principles of Business Continuity Management
• Best practices for a robust supply chain
• How it translates into success stories, like with the Benzonase® family.

Apply to our Advance Biotech Grant Program and get a chance to benefit from products, services, and consultations from experts. Applications are open until April 30th, 2024.

In this webinar, you will:
•Understand the main drivers and benefits of closed processing in biopharma, including facility utilization, sustainability, cost reductions, and labor savings.
•Analyze biopharma facility design, comparing traditional layouts to innovative, modular, and ballroom-style configurations.
•Learn about industry guidance and best practices in the adoption of closed processing.

In this webinar, you will learn how our new single-use bioreactor family can help you:
– Fulfill any process strategy, be it batch, fed-batch or perfusion
– Facilitate scalability of your upstream process
– Utilize the flexible design to reduce production costs