Regulatory Articles

  1. Emulate Endorses The FDA Modernization Act Of 2021 5/10/2024

    Learn why removing the mandate for animal testing would enable faster, more efficient, and more humane drug development, all while benefiting both patients and the pharmaceutical industry.

  2. Tips For Viral Vector Production 4/16/2024

    Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

  3. Developing A Comprehensive Regulatory Approach For LNP Drugs 2/26/2024

    The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

  4. Developing Injectable Drug Placebo Formulations For Clinical Trials 1/9/2024

    Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

  5. Transitioning From Research To Drug Formulation And Development 11/27/2023

    The transition from academic research and studies to industry research demands that individuals master additional skills, set different objectives, and define “success” differently.

  6. Legal And IP Protection For New Biotechs 10/31/2023

    Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs. 

  7. Specializing In Small And Early-Stage Partners, Not Just Small Batches 8/16/2023

    Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

  8. Creating Accurate, Efficient, And Effective CDMO Project Proposals 8/15/2023

    To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

  9. 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.

  10. 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.