Featured Editorial

  1. Advanced Manufacturing And CDMOs Are Rewriting The CGT Cost Equation 7/16/2025

    Without contract manufacturers, small biotechs often don't stand a chance of reaching commercial production scales, let alone global access for their drugs.

  2. Exploring Outsourcing's Role In CGT Scalability And Affordability 7/16/2025

    CDMOs give therapy developers access to state-of-the-art production platforms and expertise without the massive up-front investment required for in-house manufacturing.

  3. 4 Centralized Comparator Sourcing Models To Fortify Supply Chains 7/15/2025

    A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.

  4. Governor Josh Shapiro On Supporting Biomanufacturing In Pennsylvania 7/15/2025

    Bioprocess Online's coverage of Governor Josh Shapiro’s fireside chat with BIO CEO, John Crowley, at the 2025 BIO International Convention.

  5. Essential Steps For A Successful Analytical Tech Transfer 7/14/2025

    Biologics tech transfer means sharing up to 20 assays. Miss a step, and you risk delays, bad data, and products stuck in limbo.

  6. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

    The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

  7. Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights 7/10/2025

    Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.

  8. Managing Extractables And Leachables In HPAPI Manufacturing 7/10/2025

    These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.

  9. Unlocking Value In Biopharma Operations: A C-Suite Call To Action 7/9/2025

    Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.

  10. Audit Trail Compliance And What To Look For In Mitigation Software 7/9/2025

    In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.