Bioprocessing White Papers

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

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

    Over the last decade, single-use solutions for virtually every bioprocess unit operation have been developed and considerable investments have been made by the industry into optimizing the quality and supply chain that underpin this technology.

  7. 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 through the use of closed systems. 

  8. 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.

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

    Virus removal using retentive filters designed to provide effective and consistent clearance of parvovirus (~20 nm) has now become an established standard in downstream purification processes for biologics produced using mammalian cells. Compared to other commonly used virus clearance methods, such as chromatography and low pH inactivation, retentive filtration is superior in its ability to clear almost all potential viral contaminants while also avoiding adverse effects on product quality. While commercially available retentive filters vary in chemical composition and structural configuration, all of these filters primarily clear viruses through the mechanism of size exclusion.

  10. The Timely Rise Of The CDMO
    6/1/2016

    The complexity of today’s molecules and the growing majority of new molecule development are calling for a new method of drug production. Biopharma companies of all sizes are looking to vendors to manage development, manufacturing, and capacity needs. The question is: Are they keeping up?