Newsletter | March 14, 2024

03.14.24 -- Understanding & Navigating Diverse Regulatory Environments


Huh? Where Did That Environmental Monitoring Hit Come From?

After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.

Developing & Implementing A Continuous Bioprocess Control Strategy

A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.

Understanding And Navigating Diverse Regulatory Environments

Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.


Your Approach To USP <382> For Your Drug Product Packaging

The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge systems.

Metabolite, Nutrient Analysis: Crucial Components For Upstream Processes

Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.

How To Develop An Efficient Downstream Purification Process For bsAbs

Bispecific antibodies (bsAbs) have gained increasing interest in recent years. Learn how to develop an efficient downstream purification process for a cancer immunotherapy bsAb.


Sandoz Acquires CIMERLI Business From Coherus, Further Building Biosimilar & Ophthalmology Leadership In U.S. Market

WEZLANA (Ustekinumab), A Biosimilar To Stelara, Now Available In Canada For Certain Chronic Inflammatory Diseases

The Cigna Group Raises Long-Term Growth Target, & Launches New Innovative Solutions At 2024 Investor Day

Fresenius Kabi’s Biosimilar Tyenne (tocilizumab-aazg) Becomes The First IV & Subcutaneous Tocilizumab Biosimilar Approved By The FDA


BD UltraSafe Plus 2.25ml Passive Needle Guard