Bioprocessing White Papers

  1. Accelerating Biopharmaceutical Development From DNA To Drug
    7/8/2016

    In the last decade, single-use solutions for virtually every bioprocess unit have been developed, and considerable investments have been made by the industry into areas that underpin this technology.

  2. Closed System Filling Technology: A New Paradigm
    7/7/2016

    “Closed system filling” is a new set of processing controls for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources.

  3. Unlocking The Potential For Efficiency In Downstream Bioprocesses
    6/16/2016

    In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

  4. Virus Retentive Filtration In Biopharmaceutical Manufacturing
    6/13/2016

    There are two different schemes to claim modular retrovirus clearance in place of performing molecule-specific laboratory scale retentive filtration studies.

  5. The Timely Rise Of The CDMO
    6/1/2016

    The complexity of today’s molecules and the growing majority of new molecule development are calling for a new method of drug production. Biopharma companies of all sizes are looking to vendors to manage development, manufacturing, and capacity needs. The question is: Are they keeping up?

  6. Best Practices For Chemical Inventory Management
    5/23/2016

    Companies that utilize chemicals in their labs and their manufacturing processes must manage those chemicals in a safe environment in accordance with government regulations. At a minimum, to ensure that this is accomplished, a system for managing information about the chemical safety and inventory data should be established and maintained. Best practices, on the other hand, take this minimum and leverage the management of the chemical inventory by taking full advantage of the people, processes, and technology involved. This white paper delves into the best practices involved in managing chemical inventory to achieve the most effective, holistic chemical inventory system.

  7. 7 Things To Know When Selecting An Electronic Lab Notebook
    5/18/2016

    Electronic lab notebooks (ELNs) are one of the primary scientific informatics solutions for helping scientists design, execute, analyze and report on experiments—but selecting the right ELN can be a challenge.

  8. Choosing The Right Rapid Prototype Source For Device Development
    5/17/2016

    Successful prototyping begins with mechanical design that will operate properly when assembled and will be scalable for volume manufacturing. A working prototype can be a smooth progression if you employ the right resources and processes.

  9. The First Step To Navigating Your Combination Product’s Regulatory Pathway: PMOA
    4/5/2016

    The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.

  10. Scalable Automation For Drug Delivery Devices
    3/31/2016

    Today’s medical device and pharma industry assembly concepts can be complex. Here, Bill Welch, chief technology officer, Phillips-Medisize, outlines why, therefore, the company provides a comprehensive assembly concept, tailored to customers’ needs. Scalability begins with early DFM (design for manufacture) / DFA (design for assembly) philosophy integrated into the product development process.