Bioprocessing White Papers

  1. 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?

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Single-Use Process Platforms Help Biomanufacturers Reduce Costs
    3/28/2016

    There are many new challenges facing those involved in the manufacture of biopharmaceuticals. Whereas in the past, overall process efficiency was sometimes treated as an afterthought as companies tried to get to market as quickly as possible, the production costs of biopharmaceuticals are now, receiving greater attention which is spurring interest in continuous bioprocessing. The loss of patent protection from blockbuster drugs is creating a market for biosimilars in which being able to compete effectively requires low prices underpinned by low manufacturing costs.

  8. Improvements And Flexibility In Vaccine Development And Production
    3/11/2016

    The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccine development timelines vary from being only a fraction of other biotherapeutics to decades of research and efforts to find an effective vaccine. Vaccination campaigns mean that often very large quantities need to be manufactured, maintained, and distributed.

  9. Modular, Flexible, Or Both? Key Considerations In Biomanufacturing Facility Design
    3/10/2016

    The shift in facility design requirements resulted in the development of modular, or building block, facility design. Often, though, the term “modular design” is interchangeably used with “flexible facility”, which requires reevaluation, as flexibility may be interpreted in different ways.

  10. Controlled Cultivation of Stem Cells – Factors to Consider When Thinking of Scale-Up
    3/9/2016

    Great hopes and expectations are linked to stem cells as a tool for drug discovery and to stem cell-derived products in therapeutic applications. Though several products have made it to commercial stage, most of the research is still performed in small scales using simple cultivation systems such as spinner flasks or T-flasks.