Industry Insights

  1. Is It Time To Stop Using Mean Kinetic Temperature (MKT) In Pharma Storage & Transport? 12/28/2020

    MKT continues to be proposed in USP chapters <659> and <1079> and is presented as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variation. However, there is too little or no emphasis on the physics or chemistry behind the impact of temperature excursions on biological drug products and other contemporary drugs.

  2. Creating A Shigella Infection Model Using Organs-On-Chips 4/9/2024

    Learn how researchers have utilized Organs-on-Chips technology to test the infectivity of Shigella through several experimental approaches.

  3. Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances 7/5/2021

    In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

  4. Facility Design & Construction Tips For Up-Start Biotech Companies 1/4/2021

    Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.

  5. Strategic API Sourcing: Offshoring Vs. Nearshoring For A Resilient Supply Chain 9/25/2024

    Generic drug manufacturers must carefully consider the decision to offshore or nearshore API sourcing. It's not only about managing costs but also about ensuring a stable and reliable supply.

  6. Best Practices For Handling Potent APIs 7/7/2015

    This article addresses the issue of how to overcome the industry challenge of handling highly potent APIs using advanced technologies and techniques that can provide a solution.

  7. The Status Quo Of Oligonucleotides Is Not The Future 12/2/2024

    The oligonucleotide field is booming, but manufacturing challenges loom. Experts discuss optimizing production for these promising therapies with flexible, sustainable, and high-yield approaches.

  8. Pursuing Automation Excellence With A Comprehensive Solution 4/10/2025

    Automating your bioprocessing workflows can significantly improve quality and scalability. To reap the benefits, implement plant-wide control software that enables seamless integration and efficiency.

  9. Back To Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies – Pharmacokinetic Studies 8/27/2021

    As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is the final installment in the four part series of frequently asked questions (FAQs)

  10. How To Adapt Efficiently To A New Era Of Supply Chain Manufacturing

    COVID-19 reshaped the pharmaceutical landscape, and its impact on the supply chain is undeniable. As the industry adapts to a new reality, executives are prioritizing reliable, forward-thinking partnerships.