Clinical Supply Manufacturing Articles

  1. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

    The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

  2. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

    This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

  3. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

    How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

  4. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

  5. Digitizing CMC Knowledge Management 4/8/2024

    Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.

  6. How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials 10/25/2024

    Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.

  7. Process Mapping For More Effective Knowledge Management 2/26/2024

    It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.

  8. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

  9. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

    Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

  10. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.