Outsourced Pharma App Notes & Case Studies

  1. Getting CMC Right For Emerging Technologies 12/20/2023

    Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

  2. Optimized Processes: A Guide To Lyophilization Cycle Development 6/25/2024

    Review the essential phases of the lyophilization cycle — freezing, primary drying, and secondary drying — and critical success factors to achieve optimal product quality and stability.

  3. A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation 1/15/2025

    Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.

  4. Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives 7/17/2024

    A gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.

  5. Implementing A Disaster Recovery Plan 8/23/2024

    When facing a malfunction, having an effective disaster recovery plan can make the difference between a swift fix, and losing your samples and time.

  6. Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel 10/19/2023

    Here, we describe the design and performance of a degenerate PCR-based approach to broad virus screening that can be used in testing bulk harvest material derived from CHO cells.

  7. 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.

  8. Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations 9/3/2024

    The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

  9. Choosing The Right Tech To Optimize Processes And Reduce Costs For Therapeutic Proteins 3/25/2025

    Discover how scalable and cost-effective manufacturing solutions can optimize your biopharmaceutical production, ensuring the successful commercialization of your therapeutic protein and broader patient access.

  10. Lentiviral Vector Production Using Single-Use Bioreactors 5/6/2024

    Here, we outline a scalable and robust upstream process developed for LVV production of HEK293T cells and demonstrate how to expand HEK293T suspension cells.