Bioprocessing White Papers

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 

  6. 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.

  7. 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.

  8. Modern Risk Management In Global Pharmaceutical Logistics
    12/7/2016

    Everything pharmaceutical manufacturers want to know about risk in supply chain logistics but are afraid to ask. What are the rising trends impacting security of product in transport? When and where does risk mitigation become mission critical? And — perhaps the most burdensome — how can I be sure?

  9. Critical Considerations For High-Viscosity, High-Volume Drug Delivery Devices
    10/28/2016

    Issues of high viscosity and/or high volume are associated with biologics. Biologics cannot be taken orally and must therefore be delivered via an injection.

  10. Improve Operational Efficiency In Biomanufacturing With Comprehensive Automation Solutions
    10/26/2016

    This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.