Outsourced Pharma White Papers

  1. 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.

  2. COGs Process Economics For Autologous Cell Therapy 8/11/2023

    Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.

  3. 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.

  4. Control Strategies And Method Development For Nitrosamines In APIs And Drug Products 4/15/2025

    Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.

  5. Accelerated API Manufacturing: Combining All Process Development Stages 5/16/2024

    During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

  6. The Problem With Construction Quality 10/21/2024

    Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

  7. Optimizing Safety Measures For rAAV Therapies 10/11/2024

    Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

  8. Maximizing rAAV Production Efficiency: Introducing Pro10™ Cell Line 3/13/2024

    This HEK293-derived, animal component-free suspension cell line forms the foundation of a scalable, robust platform process that accelerates AAV manufacturing.

  9. Spray Drying To Enable New Inhaled Drug Products 7/11/2023

    The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.

  10. Best Practices In Formulation And Lyophilization Development: Proteins, mAbs And ADCs 10/16/2024

    Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.