Outsourced Pharma White Papers

  1. 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.

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

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

  3. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

    Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

  4. If You Can't Win The Game, Change It 12/11/2024

    Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.

  5. Streamlining ADC Development: Advantage Of An All-In-One Solution 6/2/2025

    Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.

  6. Factors To Consider While Selecting Stoppers For Lyophilized Vials 10/16/2024

    Ensure the success and stability of your lyophilized products by choosing the right container-closure system — explore your stopper options, here.

  7. Process Development For Lyophilized Products 10/16/2024

    Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

  8. Handling Protocols: Key Considerations In The Highly Potent API Market 5/12/2025

    Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

  9. SMB Technology: Optimizing API Purification 6/13/2025

    Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.

  10. Streamline Your AAV Process With A Production Platform 10/6/2025

    AAVs are reshaping gene therapy, but scaling production introduces complexity. Learn how upstream process optimization can improve yield, consistency, and speed to meet growing demands.