Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
Publication|Videos|May 13, 2024
Talking Strategic Development with Simtra at DCAT
Author(s)Simtra BioPharma Solutions
Ray Guidotti, Chief Operating Officer at Simtra BioPharma Solutions, talks about the company's strategic development and how it supports customers with a focus on excellence.
Simtra BioPharma Solutions is a premier contract development and manufacturing organization (CDMO) with more than 65 years of sterile injectable (SI) experience and a dedicated focus on providing a range of services from clinical development to commercial fill/finish. Learn more about:
- Simtra’s new building in Halle that features a high-speed syringe line and vial line equipped with four lyophilizers and is expected to be GMP ready in 2024.
- The new clinical line in Bloomington that will be ready to take on projects in the summer of 2025.
- Construction of the new state-of-the-art building in Bloomington that will begin in the summer of 2024.
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Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
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