Outsourced Pharma App Notes & Case Studies

  1. Impact Of Media Selection 6/30/2025

    To highlight the importance of media selection, a study was conducted assessing the effect of three commercially available cGMP grade medias and their influence on T-cell phenotype.

  2. The Benefits Of Aqueous Critical Cleaning 6/22/2026

    Enhance pharmaceutical cleaning by aligning chemistry, process design, and monitoring to remove complex residues, reduce contamination risk, and ensure consistent, compliant performance.

  3. Sterilizing Filtration During Small Molecule Drug Formulation And Filling 6/22/2026

    Sterile drug production relies on both prevention and remediation of contamination. A multi-stage filtration strategy reduces microbial load, protects critical filters from fouling, and ensures consistent product quality, process efficiency, and patient safety.

  4. Packing MabSelect™ And MabSelect SuRe™ Resins Using Verified Methods 12/6/2024

    Proper packing of MabSelect resins is crucial for efficient chromatography. Verified methods ensure stability, optimal flow, and reproducibility across scales using automated tools.

  5. Streamlining European Expansion With Integrated PV, Regulatory, And Commercial Expertise 4/17/2026

    See how a single-provider model integrated pharmacovigilance with regulatory and commercialization support to support a scalable, audit-ready system that strengthened compliance and freed internal resources for growth.

  6. 9 Logistics And Distribution Recommendations For CGTs 5/6/2026

    Cell and gene therapy commercialization requires tailored logistics strategies. Explore nine recommendations covering site readiness, reimbursement gaps, packaging, testing, and coordination.

  7. Scalable rAAV9 Production Using Advanced Cell Lines And Bioreactors 6/15/2026

    Progress in gene therapy manufacturing is being driven by improved cell line performance and scalable bioprocessing. See how high-density growth helps streamline development to larger-scale production.

  8. Fast-Tracking NDA Approval For A Novel Compound To Treat Infections 6/2/2026

    Strategic tech transfer and scalable manufacturing enabled rapid NDA approval, delivering registration batches and accelerating commercialization of a novel therapy for drug-resistant infections.

  9. Enabling A Four-Fold Increase In Titer For mAb Manufacturing 5/14/2026

    A platform-based upstream strategy increased monoclonal antibody titers fourfold, improving yield, efficiency, and scalability via optimized clones, process design, and rapid scale-up.

  10. From FDA Approval To Product Launch 9/3/2026

    How do you maintain supply during a major product transfer? Explore strategies used to navigate technical, regulatory, and logistics challenges.