Newsletter | October 3, 2024

10.03.24 -- The Peril Of Analytical Method Transfer

FEATURED EDITORIAL

The Peril Of Analytical Methods Transfer

Scale-up in all its iterations from bench to commercial readiness, tech transfer to an outsourced manufacturing partner, product acquisition, and even process development personnel turnover place analytical decisions made early on under a microscope. 

FDA Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals

The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations and strategies for mitigating their presence in pharmaceuticals.

Wish SUS Cost Less? Survey Says Your Peers Do, Too

BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.

INDUSTRY INSIGHTS

Glass Vials To Evolve Your Sustainability Goals

Learn more about new glass vial options that combine performance and sustainability to help pave the way to a greener future.

From Bottlenecks To Breakthroughs: Mastering Buffer Management

Watch to explore strategies to overcome buffer-related bottlenecks in large-scale biomanufacturing.

NEWS HEADLINES

Samsung Bioepis And Biogen Receive Positive CHMP Opinion For Aflibercept Biosimilar, OPUVIZ™

Despite Projections Of A 2024 Adalimumab Biosimilar Boom, Humira Remains Dominant For Now, According To Spherix Global Insights

Biocon Biologics Announces New Dermatology Data to Be Presented at EADV Congress 2024

Xbrane Provides Update From Scientific Advice With US FDA On Xdivane (Opdivo Biosimilar Candidate)

SOLUTIONS

Accelerating Bulk Harvest Testing