Newsletter | July 1, 2019

07.01.19 -- The FTC: Biosimilars' Guide Through The Patent Thicket?

Featured Editorial
Can The FTC Cut Biosimilars' Path Through The Patent Thicket?
By Stanton R. Mehr, content director, Biosimilars Review & Report

So-called "patent thickets” are a threat to the biosimilar industry and stifle the introduction of affordable generic drugs. A recent Senate Judiciary Committee hearing offered hints that the tide might be turning.

2018 FDA Warning Letter Analysis: Data Integrity Failures
By Barbara Unger, Unger Consulting Inc.

FDA enforcement for failures in data integrity and data governance has remained markedly consistent. Analyzing those failures can help you prevent, identify, and remediate common issues.

Industry Insights
Choosing The Sterile Dosage Form For Your Phase 1 Needs
White Paper | By Tony Pidgeon, Thermo Fisher Scientific

When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.

Addressing Chromatography Challenges With Fiber Adsorbents
White Paper | By Iwan Roberts, GE Healthcare Life Sciences

A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.

Role Of Cell-Based Potency Assay In Functional Characterization Of mAbs
White Paper | By Agata Burzawa and Pamela Hamill, Ph.D., MilliporeSigma (Product Characterization)

The characterization of therapeutic monoclonal antibodies (mAbs) should include a wide range of analytical techniques, as well as binding and cell-based potency assays, in order to reflect the main mechanism of action and effector function of the mAb of interest.

The Microbiologist's Role In Aseptic Filling And Sampling
Article | By Summer Wade, Singota Solutions

Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow clients access to data.

Patient-Centricity: A Drug Development Imperative
Article | By Michael Dennis and Bill Huang, AbbVie

Success in biopharmaceutical development is ultimately about facilitating positive patient outcomes. How is patient-centricity influencing the development process today, and what role do CMOs play? 

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