Industry Insights

  1. How Ring's Single-Capsid Protein Approach Optimizes Viral Delivery 11/5/2024

    Complexity and manufacturability have an inverse relationship. Ring’s platform seeks to simplify highly complex gene therapy production by making the most of biology.

  2. Anatomy Of A GMP Vendor Qualification Program

    Pharmaceutical companies are only as compliant as their vendors.  In a contract manufacturing arrangement, the manufacturer is held responsible for any cGMP deficiencies; however, you, as the sponsor or CRO, would be held responsible for your lack of vendor oversight.  Moreover, if your manufacturer fails to meet regulatory standards, you could lose millions in profits and patent exclusivity, damage your company’s reputation, and even jeopardize your entire business.

  3. Advancing Cell Therapies With Lipid Nanoparticles 3/24/2025

    Cell therapies, using reprogrammed immune cells, offer innovative treatments for diseases. Discover how lipid nanoparticles (LNPs) enhance these therapies by delivering RNA for gene modulation and next-gen treatments.

  4. Insights And A Peek Into The Future For PRO & ePRO 12/12/2011

    PHT Corporation’s U.S. PRO & ePRO Congress, held in Boston Nov. 9-10, shared electronic patient reported outcome (ePRO) adoption growth numbers, discussions of new regulatory guidance, actionable information that can ease site and study subject burden from ePRO, PRO and ePRO in post-approval, and lingering reasons for sponsor reluctance to adopt ePRO. By Sara Gambrill

  5. 5 Recommendations To Maximize CSV/CSA Outcomes 7/17/2024

    The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

  6. The Asia-Pacific Region: A Hot Spot For Clinical Trials 3/2/2021

    The Asia-Pacific region has become the hot spot for conducting clinical trials. Why? There is an ease of regulatory compliance, a low cost of conducting studies, a growing patient population, and the presence of a few top clinical institutions acting as sites.

  7. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

    Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

  8. Your Approach To USP <382> For Your Drug Product Packaging

    The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.

  9. Why Royalty Financing Is A Smart Funding Alternative For Small Life Science Companies 9/27/2023

    Royalty financing has emerged as an attractive solution to secure funding in the current challenging fundraising environment, offering a range of advantages tailored to the unique characteristics of small life science companies, from preserving ownership and intellectual property control to providing accessible funding for high-risk ventures.

  10. What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025

    The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.