Regulatory Articles. App Notes, Case Studies. & White Papers

  1. Longhorn's Path To A Universal Influenza Vaccine 12/2/2022

    Thanks to the long-term planning of one biopharma family and some help from the U.S. Army, a universal influenza vaccine is coming soon to a clinical trial near you.

  2. Successful Filter Integrity Testing Using The WIT Method 11/15/2022

    Explore the collected best methods/practices to give filter end users the best possible chance of performing a successful water intrusion test.

  3. Cybersecurity And Product Design Of Automated Systems 9/30/2022

    Learn about the importance of cybersecurity for automated equipment, it's weaknesses and risks, and how to mitigate for them by sensible practice and good system design.

  4. Successfully Producing Insoluble Proteins Using Inclusion Bodies 9/27/2022

    Review the pros and cons of soluble and insoluble processes, experiences with isolating, solubilizing, and properly re-folding, and strategies and innovation to improve insoluble processes.

  5. Apheresis Variability Control In Cell Therapy Manufacturing 7/25/2022

    Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.

  6. Reasons To Buy Into A Joint Auditing Program 5/26/2022

    Learn how you can save costs and time by having access to licensable joint audit reports.

  7. Regulatory Convergence With Aurion Biotech 5/18/2022

    Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach.

  8. Flexible Expression Technologies For Mammalian, Microbial Proteins 5/3/2022

    Drs. Joachim Klein and Rebecca Michael from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s options for expressing and manufacturing complex biologic drugs.

  9. Which Testing Does An Effective Certificate Of Analysis Include? 2/16/2022

    Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

  10. Method Transfer – When, Why, How? 2/16/2022

    A formal method transfer is an exercise that demonstrates and documents that a method has been successfully qualified in another laboratory to provide accurate and repeatable results.