Facilities Featured Articles

  1. Perfusion – Do’s And Don’ts To Cut Production Costs, Increase Efficiency
    8/25/2017

    Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach.  Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.

  2. Batch And Fed Batch Culture — Practical Steps For Better Results
    8/25/2017

    Design of Experiments (DoE) mathematical models can help create the perfect environment for batch and fed batch cultures. Understanding the different criteria  and their interactions with each other can be a key differentiator in the race to get your drug to market. 

  3. Fermentation And Cell Culture: Bringing The Basics To The Fore
    8/25/2017

    Fermentation and cell culture can be carried out in batch or continuous processes.  Reminding ourselves of the basics is vital for the development of more cost-effective and efficient biotech production processes. This article reviews those basics to understand the methods best suited for your development.

  4. Practical Guidelines For Lab-Scale Processing In Volumes <50L
    8/25/2017

    The understanding of lab-scale processing, from cell and media type to bioreactor size and scale-up, is a vital part of its development. This article reviews the key steps and considerations to aid in developing the process while keeping costs down.

  5. Factors To Consider When Selecting A Pharmaceutical Contract Manufacturer (CMO)
    8/25/2017

    Key drivers to help you make the right decision if you do turn to a pharmaceutical CMO.

  6. Dealing With Demand Uncertainty In Biologics
    8/24/2017

    When a biologics company is preparing to launch a new product, its manufacturing capacity forecast is subject to a great deal of uncertainty. Biologics developers must consider scale and volume — in that order.

  7. There’s No Such Thing As A “Perfect Blend” – Uniformity Factors In Pharmaceutical Mixed Powders
    8/15/2017

    Identifying the many factors that factor in when trying to obtain the perfect blend for your powder formulation.

  8. The Increasing Impact Of Single-Use Equipment In Pharma Manufacturing
    8/14/2017

    A closer look at the advantages and disadvantages of single-use production sheds light on why it is increasingly being seen as a possible future standard in pharmaceutical drug production.

  9. A Practical Approach To GMP Cleanrooms And Cleanroom HVAC
    8/14/2017

    ISPE has provided a set of tools that facilitates a clearer understanding of the application of di€fferent GMP regulations, standards and guidelines in everyday work.

  10. Solving the OOS Problem with Continuous Manufacturing
    8/13/2017

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec. And when it isn’t, as will sometimes (albeit rarely) happen, the manufacturer can step in more quickly than ever before to limit the volume of OOS product — saving time, money, and staying ever closer to the ideal quality standard.