Outsourced Pharma White Papers

31. 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.

32. 20 Years Of Biosimilars: Are We On The Right Track? 6/17/2024

    Explore the transformative journey of biosimilars, 20 years in. Through industry expert insights collected from a recent panel discussion, explore regulatory hurdles, market shifts, and the path ahead.

33. 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.

34. Quality By Design (QbD) For Biologics From A CDMO Perspective 2/18/2025

    Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

35. Analytical Approach For Bispecific Antibody Quality Study 11/25/2025

    Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications.

36. Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration 7/7/2025

    Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

37. 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.

38. Building the Next Generation of TIDES Manufacturing Excellence 2/12/2026

    Rising demand for complex TIDES therapies is shifting manufacturing expectations, driving adoption of continuous processing, digital tools, stronger supply strategies, and greener, scalable synthesis.

39. Advancing Drug Development With Optimized LC-MS/MS Bioanalysis 5/7/2025

    Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.

40. Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing 2/11/2025

    Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.