Mike Ulman

1 month ago | cellandgene.com | Erin Harris |Mike Ulman |Jay Collins |Chris Hofmann

Introducing a new way to source solutions for improving, refining, and optimizing your CGT manufacturing! From April 8-10, Life Science Connect brings you the next virtual showcase from its network of trusted communities: Cell & Gene Therapy Tech Expo.

Sep 19, 2024 | bioprocessonline.com | Mike Ulman |Crystal Hostler |Mesa Laboratories |Robert Ossig

PAT: Build Quality into Biopharmaceutical Processes with Real-Time Monitoring and ControlAutomated aseptic sampling is a process analytical technology (PAT) tool that offers significant benefits for bioprocesses, including reduced contamination risk, higher measurement frequency, and improved efficiency compared to standard manual sampling. As a result, it enables improved process understanding and tighter process control. Learn more here.

Sep 12, 2024 | biosimilardevelopment.com | Jayet Moon |Arun Mathew |Mike Ulman |Anupreet Kaur

Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations. The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

Jul 12, 2024 | meddeviceonline.com | Mike Ulman

By Mike Ulman, Technology Manager, Packaging and Delivery Systems The article provides a comprehensive overview of the roadmap for developing an injectable combination product, such as a pre-filled syringe or auto-injector. It emphasizes the importance of conducting a risk assessment to determine the necessary tests for the product, as well as complying with regulatory requirements and creating a Design and Development Plan.

Jul 12, 2024 | bioprocessonline.com | Mike Ulman

By Mike Ulman, Technology Manager, Packaging and Delivery Systems The article provides a comprehensive overview of the roadmap for developing an injectable combination product, such as a pre-filled syringe or auto-injector. It emphasizes the importance of conducting a risk assessment to determine the necessary tests for the product, as well as complying with regulatory requirements and creating a Design and Development Plan.