Bioprocessing White Papers

  1. MVM Resistance Through Genetic Engineering
    9/13/2016

    Contamination in the manufacturing process can be a rare but catastrophic event costing a company millions per contamination in clean-up costs along. This does not include any loss of revenue due to missed product sales or the impact to the patient population due to loss of drug supply. Even with the use of animal origin free and animal component free systems, there have been recorded contaminations of CHO cells by Minute Virus of Mice (MVM) also called Mouse Minute Virus (MMV).

  2. Speed Up The Pace Of Chemical Research And Development
    9/12/2016

    Today’s chemical development labs are busy places that create fascinating new chemicals, new formulations and new products that boost the bottom line. But are these labs as efficient as they could be?

  3. Is Automation The Disruption Pharma R&D Needs?
    9/6/2016

    According to a recent report from PhRMA, U.S. biopharmaceutical companies spend more than 13 times the amount of R&D per employee than all other manufacturing industries.

  4. 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. Every record within your company represents a huge opportunity for organizations wishing to act with agility, so the proper management that information should be a priority.

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

    Manufacturers and shippers of these products are under increasing pressure, as pharmaceutical and life science logistics becomes more complex and as the consideration towards better control of falsified medicines increases.

  6. 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.

  7. 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.

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

    The pipeline of biopharmaceutical drugs is rich and becoming increasingly diverse. Many new biologic modalities are being developed as established therapeutic classes move through their lifecycle. Wide arrays of different types of molecules are expected to coexist within product portfolios and manufacturing networks. It is clear that this will have a significant impact on manufacturing facilities. Strategies need to be developed to prepare facilities for these challenges.

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

    “Closed system filling” is a new set of processing controls appropriate for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources through the use of closed systems. This is an automated sterile connector technology by which presterilized closed containers are filled through an engineered and controlled passage enabling the filled product, the internal container and the closure system surfaces to avoid exposure to the background environment.

  10. 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.