Outsourced Pharma White Papers

  1. Designing A Disinfectant Study For Your Cleanroom 5/14/2024

    Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.

  2. Establishing Commercial Manufacturing Services For ADCs 6/3/2024

    Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.

  3. Leak Rate Testing for Freeze Dryers: A Scientific Approach 10/16/2024

    Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.

  4. Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection 10/3/2024

    Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

  5. Quantitation Of Monoclonal Antibodies In Serum 2/8/2024

    Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.

  6. Support Of Scale-Up And Technical Transfer Through Understanding Equipment 10/16/2024

    See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

  7. Compound Library Consortium 5/16/2024

    Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.

  8. Assessing Reliability, Confidence, And Batch Variation In PPQ Runs 6/29/2023

    Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.

  9. The Shift Toward Western Pharmaceutical Manufacturing 5/16/2024

    Delve into the complexities of securing and de-risking pharmaceutical supply chains in light of vulnerabilities and prompting renewed conversations about reshoring production.

  10. Extended Head Flats Increase Dwell Time 4/25/2024

    Explore the extended head flat and how this punch modification can improve the compression of difficult formulations.