By Robert Browne, Fuld + Company

Within the last few years, the FDA has taken steps to approve more biosimilar products and has committed to providing for a competitive landscape. The three latest biosimilars to be approved by the FDA have all been biosimilars to Herceptin. Further, Pfizer’s Trazimera, the most recently approved trastuzumab biosimilar, has sparked intrigue. As a result, Genentech is bracing for Herceptin biosimilar commercial launches in 2019.

By Ray Sison, xCell Strategic Consulting, LLC

Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) execution can be time-consuming and difficult. An MSA is not a novel, read from front to back — it is a functional legal document that provides operational, financial, and legal guidance that will be referenced as needed throughout the term of the agreement.

Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.

The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.

As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. 

Personalized medicine has the untapped potential to unlock value for both patients and providers. However, biomanufacturers face major obstacles in drug development, such as increasing regulatory oversight, longer development times, and a growing public focus on drug pricing. This e-book outlines some of those struggles as well as highlights the successes of those working to advance the personalized medicine industry.

Bio-Rad Laboratories, Inc.

AbbVie

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