Bioprocessing White Papers

  1. Managing Risk In Biomanufacturing
    6/6/2017

    Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

  2. Evaluating Pharma And Biopharma Facility Design Options
    5/31/2017

    In the pharmaceutical and biopharmaceutical industry several factors have converged to change the landscape in regard to facilities.

  3. Blow-Fill-Seal For Biologics: Breaking Through In Pharma Packaging
    5/3/2017

    As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. 

  4. Planning And Executing Cycle Development For The Vapor Hydrogen Peroxide Decontamination Of A Filling Line Isolator
    4/6/2017

    The cycle development approach described in this document is fairly universal and should not be dependant on individual isolator systems. The terminology used may be slightly different depending on the technology.

  5. Broaden Analysis Of Compound Factors For Predictive Solubility Solutions
    3/2/2017

    Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

  6. Purification Of Mammalian Virus In A Single Step
    2/28/2017

    In this white paper, ceramic hydroxyapatite media is used for purification of a wide variety of mammalian viruses.

  7. Streamline Change Control In Today’s Complex Life Sciences Organizations
    1/11/2017

    One area coming under increased regulatory scrutiny is change control: the ability to manage deviations to established policies and procedures in a way that is efficient, timely and compliant.

  8. Selecting An Automated Solution For Tracking Product Registration And CAPA Management
    1/11/2017

    In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. 

  9. Electronic Archives For Regulatory Retention Compliance In Life Sciences
    1/11/2017

    Find out the characteristics of electronic archives and history supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.

  10. 5 Reasons External Collaborations Fail In Drug Discovery
    1/11/2017

    This white paper, brought to you by Dassault Systèmes BIOVIA, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.