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

  1. Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility 3/24/2023

    As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

  2. Inspiring A New Era Of Patient-Centric Medicines 3/23/2023

    Patients are more empowered, making it essential to promote better adherence, improve medical benefits, and bolster market perception. See the technologies enabling this shift toward patient-centricity.

  3. Partnering On An Innovative Hydrogel-Based Treatment For Glioblastoma 3/22/2023

    Treatments for glioblastoma multiforme (GBM) are in high demand. Learn more about the new possibilities for increased dosing and diffusion capabilities offered by nanoformed APIs.

  4. Match Your Development And Manufacturing Path To Your IND Milestones 2/17/2023

    The drug development journey is long, expensive, resource-straining, and risky. Discover how to maximize the value of early-phase material and match your development path to your IND milestones.

  5. 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.

  6. 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.

  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.