Outsourced Pharma White Papers

31. Optimizing Reference Standards For Your Biopharmaceutical 1/29/2024

    By addressing considerations for a comprehensive reference standard strategy, manufacturers can ensure the integrity of biopharmaceuticals, ultimately paving the way for better patient outcomes.

32. Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing 8/22/2024

    Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

33. 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.

34. Stability Services 4/28/2025

    Dive into a summary of stability considerations and process examples for recombinant proteins, mAbs, gene therapy, and subunit vaccines.

35. Improving Methodologies For iPSC Manufacturing And Differentiation 9/30/2025

    Learn how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and overcome the hurdles of scalability and consistency.

36. Is Mannitol Hemihydrate Detrimental To Protein Stability? 10/16/2024

    Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.

37. Single-Use Innovation For The Future Of Therapeutic Manufacturing 1/28/2025

    Gain insight into these end-to-end plasmid DNA solutions, leveraging robust cGMP-compliant processes and single-use manufacturing platforms to accelerate your cell and gene therapy programs.

38. Simplify CAPA In 7 Steps 9/20/2024

    Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

39. Facilitate Handling Of Bulk Powders With Dry Granulation 8/11/2025

    Handling bulk powders in manufacturing presents serious challenges—from unpredictable caking to safety risks—that can disrupt workflows. Discover solutions to streamline operations and protect your team.

40. Developing Effective Procedures 10/21/2024

    Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.