Bioprocessing White Papers

  1. 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.

  2. 5 Reasons External Collaborations Fail In Drug Discovery
    1/11/2017

    Pharma has come to the realize that certain activities should no longer be part of their core drug development process, and by focusing on these activities, they are losing a competitive advantage.

  3. 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?

  4. Critical Considerations For High Viscosity/High Volume Drug Delivery Devices
    10/28/2016

    By 2020, biologics are expected to make up more than half of the world’s top 100 selling drugs. To keep pace with these trends, device designers are tasked with overcoming various challenges associated with delivering these drugs. In particular are issues of high viscosity and/or high volume (HV/HV) associated with biologics. Since biologics cannot be taken orally, as the conditions within the stomach denature the molecules, biologics must therefore be delivered via an injection. While the challenges of HV/HV are not unique to biologics alone, per the abovementioned market trend, these drugs demand special attention from device developers.

  5. 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.

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

    If more than 85% of your single-use assemblies are customized, you are likely over customizing at the expense of time, performance, and quality. Excessive customization is a key challenge of implementing single-use technology.

  7. 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).

  8. 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?

  9. 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. 

  10. 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.