Newsletter | November 2, 2023

11.02.23 -- FDA Updates Labeling Recommendations For Biosimilar Products

FEATURED EDITORIAL

Effective Quality CDMO Contracting

Choosing the right CDMO is a complex and difficult task and, given the regulatory framework within which the industry operates, it is essential that companies seeking a CDMO get the right partner. Let's look at what you should include in RFPs and other key considerations.

Have You Adopted A Manufacturing Execution System Yet?

Manufacturing execution systems (MES) have become crucial in managing biopharmaceutical operations to ensure compliance and promote efficiency. This article shares the benefits of adopting a MES, the three deployment options, manufacturing applications for a MES, and more.

Survey Results Show What Could Finally Make Sustainability Stick

Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.

INDUSTRY INSIGHTS

Meet Stability Testing Expectations In Today's Complex Pharma Landscape

What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.

Successful Industrialization Requires Solid Foundations

Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialization of an injectable drug product and review some of the associated challenges.

Integrated Systems For Sophisticated Drug-Device Combination Products

Experts discuss the benefits of using integrated systems for sophisticated drug-device combination products with multiple device subsystems, and the crucial role a partner can play as systems integrator.

NEWS HEADLINES

Updated FDA Labeling Recommendations For Biosimilar & Interchangeable Biosimilar Products

Celltrion USA Announces Distribution & Incorporation Of YUFLYMA (adalimumab-aaty), A Humira Biosimilar, To Carepartners Specialty Pharmacy Cost Savings Programs

Organon Canada Announces Availability Of A High-Concentration, Citrate-Free Formulation Of HADLIMA, A Biosimilar To HUMIRA

Samsung Bioepis Wins 2 Categories At The Global Generics & Biosimilars Awards 2023

SOLUTIONS

Is The Sensitivity Of Optical Biosensors Important?

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