INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• The New Clinical Packaging Paradigm: Differentiation And Decentralization

  The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?

• June 2025 — CDMO Opportunities And Threats Report

  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.

• Viral Clearance Services

  Ensure safety with expert-led viral clearance studies. Our global team delivers regulatory-compliant, scientifically robust solutions to eliminate viral risks and support your product’s success.

• Securing INmune Bio's Trial Materials In A Crisis

  Discover how a sudden biostorage shutdown put INmune Bio’s trial at risk, revealing the critical importance of logistics and rapid coordination in protecting advanced therapy programs.

• UpTempo℠: Seamless Transitions From Bench To CGT Applications

  Accelerate cell and gene therapy development with high-yield, regulatory-compliant plasmid DNA manufacturing that shortens timelines, minimizes risks, and streamlines your supply chain.

• Exploring The Market For Closed-Loop Cell Therapy Production

  The second part of a discussion on closed-loop systems explores the CDMO and equipment landscape for scaling automated closed loop cell therapy manufacturing systems.

• Dispelling Common Clinical Trial Oversight Myths

  Many clinical trial oversight problems can be avoided or mitigated by sponsor understanding root causes and being a proactive collaborator with its partners.

• AAV Production: Your AAV CDMO Partner, Every Batch, Every Milestone

  Confidently navigate every stage of development with tailored tech transfer solutions backed by AAV expertise. Discover how to de-risk, scale, and optimize your process for high-quality performance.

• Scaling Up Manufacturing? Here's Why You Need A CMC Specialist

  CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

• Why Embrace Diversity, Equity, And Inclusion In The CDMO/Biopharma Sector

  Recognizing and integrating diversity, equity, and inclusion (DEI) is essential for fostering innovation, improving team performance, and ensuring long-term competitiveness in a global market.