Newsletter | May 9, 2024

05.09.24 -- Sandoz, Amgen Resolve Denosumab Patent Litigation

SPONSOR

Webinar: Key Elements of Process and Analytical Development to Support Biologics Tech Transfer

Join us on May 13th as our expert panel discusses the intricacies of technology transfer, drawing from real-life case studies. Investigate critical components for success, risk assessment, and effective mitigation strategies. Learn how to optimize your timeline and enhance efficiency in your transfer processes. Click here to learn more.

FEATURED EDITORIAL

Single Use In Biopharma: Beyond Savings & Sustainability

SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. On April 24 at 11 AM ET, we’re diving into it live with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.

What Time Is Best To Bring My CDMO On Board?

The answer might be sooner than you think and entail more transparency than you're used to.

GMP Plant Uniform Lockers And Procedures: Best Practices

As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.

INDUSTRY INSIGHTS

Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest

Review the process that helped a customer drastically reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

Leveraging Autoinjector Innovation To De-Risk Biosimilar Development

Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

NEWS HEADLINES

Sandoz Reaches Agreement With Amgen Resolving All Patent Litigation Related To Its US Denosumab Biosimilars

Henlius Trastuzumab Receives FDA Approval In The United States

Xbrane Provides Regulatory Update On FDA Review Of Its Ranibizumab Biosimilar Candidate

US FDA Approves High-Concentration, Citrate-Free Formulation Of Cyltezo® (adalimumab-adbm) Injection, Boehringer Ingelheim's Interchangeable* Biosimilar To Humira®

U.S. Commercialization Agreement With Quallent To Drive Patient Savings With First High-Concentration Citrate-Free Interchangeable Biosimilar To Humira (adalimumab)

SOLUTIONS

Large Scale Buffer Management System