Bioprocessing White Papers

  1. Reducing Total Cost Of Ownership In Media Filtration
    3/20/2018

    The production of monoclonal antibodies (mAb) and recombinant proteins has undergone significant progress in recent decades. Higher titers and increasing cell densities present challenges to upstream and downstream bioprocessing groups alike. In downstream processing, this challenge is quite clear (i.e., purification of larger product masses with currently available equipment/technologies is an on-going industry topic), but these changing conditions bring major challenges in upstream bioprocessing as well.

  2. Aseptic Sampling Product Manager On PDA Technical Report No. 69
    3/20/2018

    This paper delves deeper into aseptic sampling devices to explain how they offer superior performance in the effort to control contamination.

  3. Can Your Clinical Supply Chain Pass The Brexit Pressure Test?
    3/13/2018

    - Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask

  4. Buffer Management Solutions For Large-Scale Bioprocessing
    2/1/2018

    How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.

  5. A Molecule’s Journey – Break Down Roadblocks To Commercial Success
    1/4/2018

    A guide for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully build their own cGMP biomanufacturing facility.

  6. Scalable Strategies For Parenteral Dosage Form Selection
    12/29/2017

    Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

     

  7. Single-Use Automation: Unlock The True Potential Of Single-Use Tech
    11/9/2017

    Discover how through automation, it is possible to achieve data acquisition, process monitoring and control, and batch record generation, allowing more complex unit operations to be run in cGMP environments.

  8. The Race To Phase III: A Cautionary Tale Of Scalability
    10/30/2017

    Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

  9. Successful Commercial Strategy For Advancing A Molecule From The Laboratory To The Clinic
    10/24/2017

    Experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible  without sacrificing product quality, process efficiency, or patient safety.

  10. Laying The Foundation For Viral Safety
    10/20/2017

    Mitigating the risk of viral contamination in vaccines, cell, and gene therapies.