White Papers

  1. Digital Manufacturing Of Biologics
    2/19/2019

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.

  2. Cell Therapy Logisitics
    2/11/2019

    Having a sound logistics strategy is critical to ensuring this living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.This paper will walk through key considerations for developing a successful logistics strategy for the management of cell-based material.

  3. Avoiding Hemolysis Blood Sample Collection Processing
    2/11/2019

    Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. This paper explains how can hemolysis be prevented during specimen collection as well as hemolysis and specimen handling.

  4. Standarizing Biosample Management - Why Use Collection Kits?
    2/11/2019

    Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.

  5. The Golden Retriever Lifetime Study: 5 Years Of Progress In Veterinary Health And Biobanking
    2/11/2019

    This whitepaper is an overview of a prospective cohort study of approximately 3,000 Golden Retrievers under the age of 2 years at enrollment and how the extensive data and biological sample repositories will be used for future analyses of major diseases, disorders or conditions in Golden Retrievers.

  6. Defense In Depth: Off-Site Storage Of Biological Specimens And Biopharmaceuticals For Risk Mitigation
    2/11/2019

    Choosing an offsite storage facility means asking the right questions, to determine if the storage provider has the appropriate risk mitigation infra-structure in place, beginning with a realistic threat assessment for the location.

  7. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics
    2/11/2019

    If you have asked and answered these five questions, and are using a rigorously designed and qualified shipping system, then the data will provide an objective affirmation that you performed due diligence and significantly advanced the commercial success of your product.

  8. Cost Advantages Of Single Use Isolator Technologies In High Potency Drug Manufacturing
    2/11/2019

    The current trend of increased potency of drug substances is driving the need for better cleaning methods to reduce cross contamination. The Level of Detection (LOD) methods are improving so that cleaning limits can be reduced to further mitigate risk of cross contamination due to retention on the process equipment and containment devices.

  9. Optimizing Process Efficiency In Upstream Manufacturing
    2/8/2019

    Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency - a key goal for biopharmaceutical production.

  10. Understanding Sensitivity Principles For Industrial Metal Detectors
    2/7/2019

    This guide explains the concept of metal detector sensitivity, key factors that impact it, and why a small difference in spherical sensitivity performance can mean a big difference in the length of wires or other irregular-shaped
    contaminants that can be detected.