Industry Insights

  1. Key Productivity, Scalability Considerations 9/21/2021

    COVID-19 caused biopharma innovators, CDMOs, data management firms, and raw material suppliers to collaborate at a level never seen before. How do we maintain that collaborative spirit under duress?

  2. Rethinking Manufacturing Processes To Identify Green Opportunities

    Reducing the carbon footprint of your pharmaceutical fine chemicals manufacturing process requires a shift from the traditional process development approach. Sustainability requires revolutionary changes.

  3. Balance cGMP And BSL-3 Regulatory Requirements 6/12/2023

    Find the right solutions for your organization to comply with and maintain product quality and safety despite conflicting cGMP FDA 21 CFR Part 210 and 211 cleanroom and BMBL requirements.

  4. Biologics CDMO: 3 Qualities Often Overlooked 12/12/2025

    A partnership can deliver more than process support. Transparency, regulatory expertise, and IP protection are critical benefits that safeguard your autonomy and innovation while enabling global success.

  5. The No. 1 Most Common Problem In FDA GMP Inspections 6/20/2022

    With issues involving quality responsibilities and procedures at the top of the FDA warning list, we uncover where the solution to make this problem a thing of the past.

  6. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

  7. The Case For Pre-Owned Equipment In Drug Manufacturing 9/8/2025

    Discover how used equipment can deliver faster ROI by eliminating long lead times and reducing capital outlay, allowing for quicker production and revenue generation.

  8. Understanding The FDA's KASA Framework 10/30/2019

    The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed. 

  9. Navigating EU GMP Annex 1 Revisions In Drug Manufacturing 11/27/2023

    Explore changes introduced by the revised EU GMP Annex 1, key considerations to maintain compliance, and stark statistics that underscore the consequences of non-compliance in this evolving landscape.

  10. 4 Key Considerations For Onshoring Or Nearshoring Of Drug Production 6/28/2023

    Is reshoring or nearshoring right for your organization? It's important to undertake rigorous internal assessments to arrive at a decision. Here are four key considerations.