Regulatory

1. Regulatory And Biosafety Testing Expertise 3/31/2026

   Advancing biologics requires confidence in safety, quality, and compliance. Learn how integrated analytical and biosafety testing, backed by decades of expertise, helps reduce risk.

2. Platforming And The Future Of Standardized Manufacturing Chassis 4/20/2026

   Platforming downstream processes offers efficiency gains, while upstream processes are standardizing on high-intensity perfusion or fed-batch. Robust analytical data allows for modern efficiencies like single-use systems.

3. A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems 11/10/2025

   In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.

4. Creating Technical Debt When Experimenting With 3D Printed Parts 7/29/2026

   Companies need mature validation paradigms to recognize if and when it's time to transition from a prototype 3D printed part to a sustainable version, likely through a vendor-validated part.

5. Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing 1/4/2021

   The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.

6. Standards' Role In Biosimilarity Assessment 4/20/2026

   Standards are useful tools for specific purposes, but they represent a one-point target. They do not capture the full range of variability found in reference products on the market.

7. Closing The Data Package Gap For In-House 3D Printed Parts 7/29/2026

   Vendor supplied single-use components come with mostly-complete data packages. That luxury doesn't exist when you make your own parts using a 3D printer.

8. Level Up With Product Characterization 3/12/2021

   In the race to bring a new biotherapeutic to market, unexpected obstacles can slow you down or even knock you back a few steps. But with the right information at the right time, and an experienced partner to provide scientific, regulatory, and bioprocessing guidance and support, you can find a smoother, faster path to the finish line.

9. Comparing Biosimilars To Drifting Reference Product Data 4/20/2026

   First-time biosimilar developers might be surprised to find significant lot-to-lot quality attribute shifts in their reference product.

10. Master The 2-Point Calibration Process To Maintain Data Integrity 5/19/2025

    Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.