Cell and Gene Outsourcing

31. Navigating Regulatory Expectations For Injectable Packaging 12/4/2025

    Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.

32. Understanding The Real Risk When Using Research-Grade Material For In-Human Testing 12/4/2025

    When it comes to putting medicine made with research-grade raw materials into people, experts say: proceed with extreme caution. "There are a lot less controls than you think," says Lawrence Thompson in this segment of Cell & Gene Live "Viability On The Line." Beyond material quality, facility controls play a critical role. He doesn't choose materials unless he can visit the facility and put eyes on their processes, he said.

33. Navigating Conflicting Raw Material Preferences With Your CDMO 12/4/2025

    Choosing raw materials is both a scientific and a business decision. In a perfect world, you as the sponsor and your CDMO would agree on raw material fitness based on the data. But cost and availability are important factors, too.

34. Timing Tech Transfer With Complex Raw Materials 12/4/2025

    Tech transfer complexity depends on product maturity, but don't assume a straightforward experience just because you have market approval and a commercial product. In fact, the risk is often greater. When outsourcing drug product manufacturing to scale up for clinical production or expanding capacity for a commercial product, it's best not to guess, Yan Zhi says in this segment of Cell & Gene Live "Viability On The Line."

35. Managing Risk With A Platform 12/4/2025

    Once your quality team has defined your priority risks, a platform designation can help whip them into submission. Building a platform alongside novel drug development gives you a template rooted in prior knowledge to control risks for subsequent products.

36. Reclaiming Control From Your Raw Materials 12/4/2025

    The high cost of GMP-grade materials and testing threaten to cripple biotechs and academic labs. Understanding your purpose is the first part of reclaiming control of your product and process. If you want to publish papers, research-grade material should be sufficient from start to finish.

37. Building Supply Chain Resilience When Dual-Sourcing Isn't An Option 12/4/2025

    Crafting a resilient supply chain, one where redundancy is out of the question, is easier said than done. Robust communication with suppliers helps ensure mutual understanding of needs. Preventing waste is a no-brainer but challenging to execute. Thoroughly characterizing critical quality attributes may offer some flexibility in choosing raw materials, in some cases, when they become scarce.

38. CDMO Media And Buffer Outsourcing: A Strategic Advantage 12/4/2025

    Learn how outsourcing cell culture media and buffers removes bottlenecks, freeing specialized CDMO resources. Ensure consistency, accelerate timelines, and streamline GMP readiness for client success.

39. Regulatory Strategy And Submission Support 12/2/2025

    This Regulatory Operations Team enables biotech and pharmaceutical companies to focus on innovation while ensuring a smooth, compliant path to market entry.

40. Toxicology Support: Regulatory Strategy And Submission Support 12/2/2025

    Eliminate delays and ensure seamless regulatory alignment with an experienced toxicology services team.