Bioprocessing White Papers

  1. The Five-Point Plan To Fix Your Records Management Strategy
    8/26/2016

    Given the ever-increasing amounts of information being generated by systems, applications, and measurement tools, a strategic approach to managing information is a requirement, not a luxury. 

  2. Managing The Complexities Of Pharmaceutical And Life Science Logistics
    8/25/2016

    For most pharmaceutical companies, a key challenge is the ability to create and maintain an innovative and competitive distribution channel strategy.

  3. Continuous Processing Optimization With Smarter Tools
    8/17/2016

    Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.

  4. Countdown To The 2017 DSCSA Deadline: Serialization Strategies For Compliance
    8/16/2016

    The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.

  5. A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms
    8/11/2016

    The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.

  6. Crystalomics: A Pathway Forward For Protein Crystallization
    8/5/2016

    One way to lower the suspension viscosity of a drug is through the use of highly-concentrated crystalline suspensions, or protein crystals.

  7. Accelerating Biopharmaceutical Development From DNA To Drug
    7/8/2016

    In the last decade, single-use solutions for virtually every bioprocess unit have been developed, and considerable investments have been made by the industry into areas that underpin this technology.

  8. Closed System Filling Technology: A New Paradigm
    7/7/2016

    “Closed system filling” is a new set of processing controls for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources.

  9. Unlocking The Potential For Efficiency In Downstream Bioprocesses
    6/16/2016

    In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

  10. Virus Retentive Filtration In Biopharmaceutical Manufacturing
    6/13/2016

    There are two different schemes to claim modular retrovirus clearance in place of performing molecule-specific laboratory scale retentive filtration studies.