Bioprocessing White Papers

  1. 7 Things To Know When Selecting An Electronic Lab Notebook

    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.

  2. Choosing The Right Rapid Prototype Source For Device Development

    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.

  3. The First Step To Navigating Your Combination Product’s Regulatory Pathway: PMOA

    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.

  4. Scalable Automation For Drug Delivery Devices

    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.

  5. Single-Use Process Platforms Help Biomanufacturers Reduce Costs

    Enhanced flexibility and reduced operating costs are being achieved through the widespread adoption of single-use technology either as part of completely single-use processes or as hybrid solutions.

  6. Modular, Flexible, Or Both? Keys To Biomanufacturing Facility Design

    Discussions are widespread about the paradigm shift in the manufacturing site design and flexibility needs of the biopharmaceutical industry.

  7. Controlled Cultivation of Stem Cells – Factors to Consider When Thinking of Scale-Up

    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.

  8. Advanced Biofuel Development Using Parallel Bioreactor Systems

    To make biofuels such as bioethanol and biodiesel competitive with fossil fuels extensive research in the field of process development is needed. Taking into account the special requirements of biofuel production, such as high temperatures, multi-step procedures and anaerobic conditions, effective tools for streamlining development efforts must be provided.

  9. Changes To GMP Force Cleanroom Reclassifications

    According to both USA cGMP and EU GMP cleanroom classification should be carried out according to ISO 14644-1. The 19994 version of this ISO standard has been re-written by a group of international subject matter experts and ISO 14644-1:2015 was published on December 15, 2015. ISO 14644-1:2015 contains substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.

  10. The Standards Myth: Why Your Temperature Controlled Packaging Is Failing And What To Do About It

    Global regulatory authorities are placing increased scrutiny on documenting control over distribution environments. While there is obviously a link between your shipping conditions and your thermal protection (packages), the challenge is that there is no clear, reliable industry standard temperature profile for the design of insulated packaging systems used for the distribution of products. This is because temperature profiles for packaging design should be rationalized based on not only your product characteristics, but your distribution logistics. This paper examines the lack of consistency in the current methodology for designing temperature profiles, why commonly used standards should not be used on their own, and identifies the needed parameters for consideration.