Downloads

1. Facility Monitoring System With FMS Web Client 3/20/2026

   Access FMS Anywhere! OPC UA Client/Server functionality to monitor particle counts and other environmental parameters—makes great business sense in order to reduce waste, improve yield, improve quality and increase profits.

2. UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk 3/20/2026

   Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

3. February 2026 — CDMO Opportunities And Threats Report 3/20/2026

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

4. COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy 3/20/2026

   Problems emerge when development, manufacturing, and clinical priorities fail to converge in cell and gene therapy development.

5. Quality Assurance In Pharmaceutical Water For Injection (WFI) Systems 3/19/2026

   Maintaining the integrity of Water for Injection (WFI) systems is a non-negotiable priority in pharmaceutical manufacturing. Watch this webinar to refine your contamination control strategies.

6. FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes 3/19/2026

   FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format.

7. All The Ways Global Biopharma Still Grapples With Annex 1 3/19/2026

   Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

8. How AI-Enabled Validation Technologies Enable The Predictive Plant 3/18/2026

   Discover how AI-enabled digital validation shifts manufacturers from reactive compliance to predictive intelligence, connecting validation, asset, and quality data to accelerate digital maturity.

9. Enhanced Biotherapeutic Protein Expression Using Advanced Vector Systems 3/18/2026

   Learn how optimized expression vector design and data-driven strategies can significantly enhance product titre, quality, and long-term gene expression stability in GS-CHO cell-based manufacturing.

10. Clearing The Fog On New First Air Visualization Expectations 3/18/2026

    Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.