Cell and Gene Outsourcing

31. 5 Key Considerations For Companies Outsourcing Process Development 6/9/2025

    Venture capital in biotech remains strong post-pandemic, especially in cell and gene therapies. Discover five key factors to help companies choose between in-house and outsourced process development strategies.

32. Lyophilization To Enable Drug Products Containing Labile Molecules 6/6/2025

    Develop lyophilized formulations to overcome stability challenges and significantly extend the shelf life of sensitive therapeutic products.

33. Injection Site Reaction Screening Methodology 6/6/2025

    Optimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.

34. Extractables And Leachables 6/6/2025

    Ensure the safety, quality, and regulatory compliance of your pharmaceutical or medical products with robust extractables and leachables testing tailored to identify potential risks under both exaggerated and real-use conditions.

35. Aseptic Fill-Finish 6/6/2025

    Whether you are navigating technical hurdles, scaling production, or preparing for market launch, our integrated approach ensures a seamless path from bench to bedside.

36. Bioanalytical Development And Testing For LNPs 6/6/2025

    Streamline gene therapy development by partnering with a centralized, GLP-compliant bioanalytical lab for comprehensive biodistribution studies using techniques like LC-MS/MS, RT-qPCR, and ELISA.

37. Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future 6/6/2025

    See why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.

38. DOE Methodology Reduces Cost, Time For Analytical Method Development 6/5/2025

    Here, we illustrate how our Design of Experiment (DoE) can accelerate development timelines, lower costs, and enhance decision-making across cell therapy programs.

39. Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility 6/4/2025

    Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.

40. May 2025 — CDMO Opportunities And Threats Report 6/4/2025

    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.