Outsourced Pharma White Papers

  1. 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.

  2. The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics 5/16/2024

    Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

  3. The Medicines Of Tomorrow: A Primer On The Gene Editing Landscape 8/8/2023

    Learn about the distinction between gene therapy and gene editing, as well as the therapeutic potential of CRISPR treatments and the challenges associated with clinical trials and commercialization.

  4. Outsourcing Stability Storage: A Cost-Effective And Quality-Driven Approach 8/22/2024

    Partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry by saving costs and resources, and ensuring product quality and compliance.

  5. Advancements In Microbial Manufacturing Of Biopharmaceuticals 9/26/2024

    Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

  6. Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products 10/16/2024

    Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

  7. Building A Legacy In Sterile Injectables Through Strong CMO Synergy 5/7/2025

    Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.

  8. Analytical Techniques For Assessing Quality Of Therapeutic Proteins 6/5/2025

    Evaluating quality attributes of therapeutic proteins requires a strategic, regulation-compliant selection of analytical techniques that consider molecular characteristics and phase to ensure characterization.

  9. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

  10. Small Molecule API Production: Unveiling The Impact Of Fermentation 5/16/2024

    Technological developments have led to growth in the suitability of fermentation for a myriad of applications. Explore the impact of the evolution of synthetic biology and supporting technologies on modern fermentation practice.