White Papers

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The New Chemistry, Manufacturing, and Controls (CMC) Regulations in China

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Solid-Phase Oligonucleotide Synthesis (SPOS) and Liquid-Phase Oligonucleotide Synthesis (LPOS): Complementary or Competitive Processes?

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BioPharma Due Diligence in a Shifting Global Market

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The CMC Trap: How Chemistry, Manufacturing, and Controls Failures Derail Drug Development

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Future Challenges in Biopharmaceutical Workforce Development

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Assessing Animal-Derived Raw Materials for Viral Risk

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The Potential Impact of U.S. Tariffs on the Biotech Sector: Manufacturing, Funding, and Clinical Trials

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Regulatory Overview of Combination Products

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A Novel Power BI Tool to Monitor Change Controls and Key Performance Indicators

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Optimizing Clinical Supply Chain Management

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Stability Study Design: Pharmaceutical Stability and Data Evaluation

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Gene Therapy Manufacturing

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Cell Therapy Manufacturing

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5 Critical Keys to Avoid Derailment of Drug Development

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Unlocking the Benefits of FDA Orphan Drug Designation

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Phase Appropriate CMC Considerations for Oral Solid Dosage Forms

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Choosing a CDMO

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Bridging Discovery and Delivery

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Strategies for Accelerated CMC Development

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Project Management