Outsourced Pharma White Papers

  1. Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility 10/16/2024

    The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

  2. Vial Fogging: Practical Considerations For Vial Selection 10/16/2024

    Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

  3. Extractables And Leachables: Risk Management And Analytical Solutions 10/11/2023

    Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

  4. Digital Transformation: A Critical Component For CDMOs 6/21/2023

    Learn how embracing the digital transformation is key for managing complexity of speed, service, quality, regulatory compliance, and capacity as well as the obstacles facing CDMOs looking to innovate.

  5. Can Yeast Be The Future Of Efficient Subunit Vaccine Manufacturing? 9/11/2023

    To aid in the manufacturing of new vaccines, Pichia pastoris yeast, a promising protein expression system, could be the perfect solution.

  6. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  7. Extractables And Leachables Testing 4/9/2024

    Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process.

  8. 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.

  9. Development And Regulation Of Veterinary Monoclonals 2/8/2024

    Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

  10. Solving The AAV Scalability Challenge 12/18/2024

    Explore the effectiveness of a flexible, scalable AAV manufacturing platform that incorporates well-characterized bioreactors and advanced production systems to drive the development of cost-effective, high-quality gene therapies.