Bioprocessing White Papers

  1. How Hollister Selected 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. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

  2. For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research
    1/11/2017

    “Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts 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.

  3. 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.

  4. 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?

  5. 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.

  6. 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.

  7. How To Reduce The Complexity Of Custom Single-Use Assemblies
    9/28/2016

    What started out as a simple bag for holding buffers or cleaning solutions has evolved to thousands of single-use products and entire processes. The industry is now calling for standardization.

  8. 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).

  9. 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?

  10. 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.