Bioprocessing White Papers

  1. Is Your CMO Ready For Serialization And Aggregation?

    While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?

  2. Using A CMO To Streamline Process Characterization

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

  3. Flexsafe 2D And 3D Pre-Designed Solutions For Storage And Shipping

    The growth of single-use in cGMP production requires enhanced assurance of supply and product performance. Innovative bioprocessing bag technology is meeting these challenges at every process step and application of biomanufacture.

  4. Enhanced Assurance Of Quality Supply For Single-Use Pre-designed Solutions

    Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.

  5. Ensuring Strength And Flexibility Of Single-Use Bags In All Applications

    The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.

  6. Cell Growth Performance In Single-Use Bags

    Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trends are towards higher cell densities and protein titers.

  7. Small Molecule Impurities Represent A Key Challenge When Designing Control Systems For ADC Therapeutic Manufacture

    Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise. Drawing on existing ICH guidelines, a recent publication co-authored by AbbVie suggests a science-based approach that can be applied to the design of an effective control strategy for small molecule impurities in ADC therapeutics.

  8. Is A Rapid Cooling Step Needed When Freezing Cells For Cryopreservation?

    Successful cell cryopreservation requires a controlled cooling rate. Cooling too rapidly or too slowly will lead to a poorer outcome. This study shows comparable results when freezing cells with or without a rapid-cooling nucleation step.

  9. More Efficient Bispecific Antibody Purification With Fewer Steps

    A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.

  10. What Clinical Teams Should Know About Changing Trial Logistics

    When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.