OP White Papers - random

  1. Understanding And Controlling Raw Material Variation In Cell Culture Media 9/5/2019

    An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

  2. Increasing Productivity In Hydrophobic Interaction Chromatography 2/27/2020

    In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

  3. Advantages Of A Lipid-Based Drug Delivery System For Poor Bioavailability Drugs 3/19/2019

    There are a number of reasons to choose a Lipid-Based Drug Delivery System over conventional formulation approaches when working with poorly soluble compounds. 

  4. Continuous Flow Manufacturing Of Pharmaceutical Ingredients 11/25/2019

    Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

  5. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  6. Microtableting: Going Small To Create More Targeted, Effective Therapeutics 5/5/2020

    The desire to create more targeted, effective therapeutics with fewer side effects has driven drug formulators to expand into more technically demanding areas over the past decade. Microtablets are one result of this burst of creativity and engineering expertise. Going small opens up numerous new delivery options, but also creates additional challenges for drug formulators and manufacturers.

  7. Digital Manufacturing Of Biologics 2/19/2019

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

  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. 6 Regulatory Changes Affecting Bioprocessing In China 4/2/2019

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  10. How To Avoid High Potency API Contamination 3/22/2019

    To ensure that employee exposures are kept within accepted limits and protect the environment while containing costs, pharmaceutical companies and their contract partners who manufacture and handle high containment compounds must carefully select equipment, outline processes and procedures, and deploy appropriate containment technologies. Having standards in place for engineering controls is the first line of defense against harm from cross contamination or exposure to the patient, manufacturing employees, or the environment when working with HPAPIs.In this paper learn how to determine exposure potential and select the correct equipment and technology.