Outsourced Pharma App Notes & Case Studies

  1. Development Strategies For Adenovirus-Based Gene Therapies 11/11/2024

    Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

  2. Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals 1/14/2025

    Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.

  3. Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis 6/14/2024

    This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.

  4. Process Validation Considerations 6/13/2024

    Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach.

  5. Why Cell Line Screening Is Crucial For Successful CDC Assay Development 4/28/2025

    In developing a CDC assay for therapeutic mAb characterization or QC release testing, in addition to selecting a target cell line that expresses the mAb ligand, consideration should be made to the expression of CRPs on the cell surface.

  6. Benchmarking Filtration Performance Of TFF Cassettes 5/30/2025

    Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.

  7. Production Of A Highly Concentrated Monoclonal Antibody 10/4/2024

    The production of a highly concentrated monoclonal antibody requires many process steps. Discover how to achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.

  8. Formulation Through Manufacturing Under One Roof 2/18/2025

    Partner with a CDMO that understands the unique challenges of emerging biopharma, providing expert guidance in formulation development, manufacturing, and regulatory navigation.

  9. Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials 5/24/2024

    The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.

  10. Optimizing TFF And SPTFF For High-Concentration mAb Formulations 4/9/2025

    Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.