Outsourced Pharma App Notes & Case Studies

31. AAV Production In Suspension HEK293 Cells With Single-Use Bioreactors 10/13/2022

    Explore how we expanded HEK293/HEK293T suspension cells from small cell culture (20 mL) in shake flasks up to a 10 L culture in a benchtop Xcellerex™ XDR-10 single-use bioreactor system.

32. Keys To Successful Risk Management In Clinical Trials 1/5/2021

    Explore how the keys to effective risk management require recognition of variables unique to each clinical trial while embracing consistent documentation practices, stakeholder responsibility, and best practices informed by experience.

33. Improve Productivity In CHO-K1, CHO-S, And DG44 Cells 4/18/2022

    This commercially available platform can enhance process productivity and reduce development time, thereby enabling potential reductions in manufacturing costs and accelerating time-to-market.

34. Enhance Reaction Rates For Anti-Cancer Therapy Manufacture 4/8/2022

    Applying flow chemistry techniques allowed for a new route for an experimental anti-cancer therapy which included LED-NMR reaction profiling, quantum yield measurements and Stern-Volmer quenching studies.

35. Cold Chain Logistics For Cell Therapy Production – A Conversation With Celyad’s Thomas Lequertier 8/23/2021

    Because cell therapies must be stored and shipped at very low temperatures, maintaining a therapeutic’s integrity through cryopreservation has far-reaching implications for both its efficacy and long-term commercial success. Thomas Lequertier, head of the Cell Therapy Manufacturing Unit at Celyad Oncology, recently sat down with the Business of Biotech podcast to discuss how his company has approached cold chain technology for its CAR-T therapies.

36. Optimizing A Perfusion Manufacturing Process For Commercial Production 12/20/2021

    Optimizing and scaling up a bench-scale perfusion manufacturing process requires development of validated analytics to support commercial manufacture.

37. Have CDMO Selection Criteria Changed Over the Past Five Years? 3/16/2022

    New relationship dynamics between sponsors and CDMOs contribute to new trends appearing in the outsourced activities and services as well as the way CDMO selection decisions are made. ISR shares how CDMO selection criteria has changed over the past five years and links the attributes to the Life Science Leader’s CMO Leaderhsip Awards categories.

     
38. Why Implement Aggregation Alongside Serialization Now? 10/13/2021

    Understand the business rationale for including aggregation as part of your serialization strategy, beyond the regulatory requirement.

39. Examining Column Reproducibility During Method Development In Clinical Labs 6/28/2022

    In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.

40. Scheduling Aseptic Filling For Preclinical And Clinical Batches 9/23/2021

    Flexible production scheduling from a CDMO helps sponsors control costs and timelines even when unexpected development delays occur.