The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
|Articles|August 11, 2015
Binding of peroxide sensitive API – typical challenges and how to overcome them
Author(s)BASF
Excipients are crucial for effective drug formulation, and excipient manufacturers continue to make advances in technology designed to address the formulation challenges presented by new drug substances. Pharmaceutical Technology magazine talked with Dr. Bernhard Fussnegger, Global Development and Technical Marketing at BASF, about the excipient developer’s family of peroxide-free excipients that are recommended for APIs sensitive to oxidation.
Advertisement
Excipients are crucial for effective drug formulation, and excipient manufacturers continue to make advances in technology designed to address the formulation challenges presented by new drug substances. Pharmaceutical Technology magazine talked with Dr. Bernhard Fussnegger, Global Development and Technical Marketing at BASF, about the excipient developer’s family of peroxide-free excipients that are recommended for APIs sensitive to oxidation.
Advertisement
Related to this article
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.
Swedish biotech companies have a broad and varied product pipeline that is attracting attention from venture capitalists and pharmaceutical companies.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
Jaenisch, Muraru, and Pandey debate whether AI "slop" is infiltrating pharma SOPs and deviation reports and who should catch it first.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Weekly Basal Insulin Efsitora: A New Biologics CMC Benchmark
2
EU Clears AstraZeneca's Trixeo for Asthma, Opening New Manufacturing Demand for Single-Inhaler Triple Therapy
3
The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push
4
Ask the Expert: Post-Approval Changes
5