Outsourced Pharma White Papers

31. What Pharma And Biopharma Should Know About Container Closure Integrity 8/1/2024

    Explore high voltage leak detection, headspace analysis, and vacuum and pressure decay as applied in pharmaceutical manufacturing.

32. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

    The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

33. Cell Line Development: The Linchpin In Biotherapeutic Development 1/4/2024

    Review key factors for building a reliable CLD strategy, and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.

34. Orthogonal Methods To Understand And Define CQAs Of AAV Therapies 2/24/2023

    An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

35. Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing From Experienced Industry Leaders 8/22/2024

    Testing for nitrosamines - potential carcinogens present in food, beverages, cosmetics and pharmaceuticals - is vital in the creation of Active Pharmaceutical Ingredients (APIs) and drug products.

36. Revolution In The EU Pharmaceutical Legislation Ahead 2/8/2024

    Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

37. Establishing Analytical Methods For mRNA-Based Therapies 6/13/2023

    Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.

38. Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process 2/8/2024

    Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.

39. ISO 21973: How To Ensure Full Compliance Throughout Every Step Of The Journey 6/28/2024

    Learn how ISO 21973, a vital standard for ensuring safe and reliable transport of cell and gene therapies, enhances supply chain efficiency and mitigates risks for the regenerative medicine industry.

40. Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars 2/9/2024

    The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.