Newsletter | March 5, 2020

03.05.20 -- Encouraging Biosimilar Use With The "WWKD?" Approach

Featured Editorial
“What Would Kaiser Do?” Changing The Employer Mindset About Biosimilars
By Anna Rose Welch, editor, Biosimilar Development

In this first of a two-part article based on our discussion, a payer and employer coalition director highlight some of the payer and employer-centric discussions that are being had today to both improve biosimilar access and navigate a system that has not been friendly to lower-cost competition thus far.

The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter
By Barbara Unger, Unger Consulting Inc.

This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product published in October 2019. Part 1 identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.

Industry Insights
Improved Process Economics Of Humira Biosimilar Purification
Application Note | By R. Drevland,, Bio-Rad Laboratories

This application note proposes an alternate but equally effective approach to biosimilar purification: by substituting a less expensive ion exchange resin for the affinity capture step.

Epitope Binning: A Critical Step In Antibody Selection
Application Note | GE Healthcare Life Sciences

Epitope binning immunoassays using surface plasmon resonance (SPR) can and should be deployed in the development of new potential drug candidates. This article discusses how SPR is used to characterize closely related “bins” of mAbs targeting the same epitope of the target protein and how the selection process is used to develop new vaccines, therapeutic antibodies, and diagnostic tools.

An Overview Of Insights In Pharmaceutical Manufacturing, Clinical Research, And Technology
Webinar | ISR Reports

ISR conducted approximately two dozen individual pieces of market research for syndication in 2019. This webinar will summarize many of the important learnings from these projects, providing real, usable data for 2020 activities.

  DIA 2020 Global Annual Meeting

We are thrilled to offer top-tier content and share global thought leadership in one customizable program at the DIA 2020 Global Annual Meeting. DIA 2020 is more than a meeting: It’s fueled by our common goal to bring life-saving medicines to patients. DIA 2020 consists of 250+ sessions woven through 13 unique tracks with nine different learning formats, ensuring all have the best learning experience.

ÄKTA go Chromatography System
GE Healthcare Life Sciences
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