OP White Papers - random

  1. Guidelines To Bring Your Biologic To Market: Are You Prepared? 4/16/2019

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.

  2. Combination Product Overview: Fixed Dosage 5/7/2020

    With dwindling pipelines, limited resources, & expiring patents, now, more that ever, combination products are being considered in drug development portfolios. However, regulatory hurdles, physician acceptance, and market strategy, are just a few considerations that one should address. This brief overview will cover specifics regarding fixed dosage combinations (FDC’s), and will hopefully give your company a better understanding to the challenges ahead.

  3. Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up 2/11/2020

    In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

  4. CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy 5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

  5. Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins 10/2/2018

    This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

  6. Component Selection: The Key To Your Program Success 10/1/2019

    The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.

  7. Avoiding Hemolysis Blood Sample Collection Processing 2/11/2019

    Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.

  8. Using A CMO To Streamline Process Characterization 3/19/2019

    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. 

  9. Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics 9/11/2019

    Challenges exist when developing biologic drugs to be efficacious but safe. Novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

  10. Is Your Complex Formulation Process Set Up For Success? 10/1/2019

    Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.