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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

• Traditional cell culture monitoring offers limited insights, while real-time measurement of critical process parameters provides direct indications of culture state.
• Implementing process analytical technology (PAT) for in-line, real-time measurements improves process understanding, decreases risk, and enables more advanced process control.

• Integration of Raman spectroscopy with an automated feedback loop revolutionizes biopharmaceutical manufacturing, enabling real-time glucose level monitoring and precise maintenance for optimal process quality and glycosylation.
• This innovative approach eliminates manual sampling, reduces contamination risks, and ensures reliable, real-time process control, empowering users to navigate upstream biopharmaceutical manufacturing with confidence.

• Raman spectroscopy enables inline and real-time assessment of crucial process parameters and critical quality attributes during process development and manufacturing.
• It employs a chemometric approach to identify, quantify, and measure the concentration of key compounds in complex liquid media during upstream (USP) or downstream (DSP) processes.

• Chemometrics is an interdisciplinary field that uses mathematical, statistical, and computer methods to extract valuable information from analytical data.
• When combined with Raman spectroscopy, chemometrics allows for the analysis of relevant data, enabling the generation of detailed insights on bioprocess activities and the development of more efficient models.

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.

• Raman spectroscopy enables non-destructive analysis of chemical composition and molecular structure.
• It provides real-time and in-situ measurements, allowing for sample preservation.
• Raman spectroscopy captures diverse biological and chemical information within a single spectrum and enables identification of specific molecules based on their distinct spectral signatures.

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.

• The gene therapy field is poised to deliver an increasingly broad and impactful set of treatments across many different diseases.
• A linchpin for success is a robust, cost-efficient, and scalable viral vector manufacturing workflow.
• Standardized production methods and fit-for-purpose workflow technologies are now available to address the unique development and manufacturing needs of viral vectors.
• Access to the necessary capacity and expertise along with strategies for a simplified pathway to GMP manufacturing, a shorter process development timeline, and a reduction in the exorbitant fixed costs associated with facility development are also available to help realize the true potential of gene therapy manufacturing space.