Outsourced Pharma White Papers

  1. AI Implementation To Enhance Quality 2/11/2025

    Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

  2. 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.

  3. Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing 8/22/2024

    Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

  4. 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.

  5. Mycoplasma Contamination In Biopharmaceutical Manufacturing 2/9/2024

    Learn how strict laboratory practices and routine testing for mycoplasma contamination using nucleic acid-based assays can help ensure safe, high-quality biopharmaceutical products.

  6. 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.

  7. 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.

  8. Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements 4/8/2025

    Viral Disinfectant Efficacy Studies validate cleaning protocols in pharma facilities, ensuring regulatory compliance, reducing contamination risk, and supporting safe, effective disinfection with expert CRO guidance.

  9. Accelerated Development Of Solid Oral Dosage Formulation For IND Submission 12/11/2024

    This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

  10. RNA Nanoparticle: Formulation, Process, And Characterization 10/22/2024

    As the field grows, understanding how to formulate RNA nanoparticles effectively is essential for advancing therapeutic innovations.