Newsletter | February 20, 2020

02.20.20 -- The Nurse's Perspective On Biosimilars

Featured Editorial
The Nurse’s Perspective On Biosimilars In Oncology Care
By Anna Rose Welch, editor, Biosimilar Development

Seeing as Sheldon has been in oncology care for almost 40 years and still works as an oncology nurse practitioner, she was the perfect person to speak to about the trends she’s observing in oncology care, in addition to the current role biosimilars play — and could still play — in oncology.

Litigation Review: BPCIA Federal Circuit Appeals Pending And Recently Decided
By P. Chen, F. Eyzaguirre, T. Francis, and J. Shmuel, Fish & Richardson

This is the third article in a four-part series on 2019 legal developments related to the biosimilar sector. Here, we review BPCIA Federal Circuit appeals that are pending and those that were recently decided.

An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report
By Barbara Unger, Unger Consulting Inc.

To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily digestible prose, to save you the spreadsheet struggle. 

Industry Insights
Expanded Droplet Digital PCR Multiplexing Capability Using Two Different Strategies
Application Note | By Dianna Maar, Nicholas J. Heredia, and Shawn Hodges, Bio-Rad Laboratories, Inc.

Droplet digital polymerase chain reaction (ddPCR) enables easy multiplexing of numerous targets within each fluorescent channel. Amplitude-based multiplexing achieves this by varying primer and/or probe concentrations. In probe-mixing multiplexing, probes are mixed at desired concentrations to place targets in a defined position on a 2D plot. This paper describes strategies for both approaches using the large portfolio of ddPCR assays readily available through Bio Rad.

How To Adapt Your Existing Biomanufacturing Process To Maximize Production
Article | By Patrick Guertin and Yasser Kehail, GE Healthcare Life Sciences

Achieving “smarter,” more flexible workflows requires a complete understanding of today’s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry.

Sterile Injectables Fill-Finish
Pfizer CentreOne Contract Manufacturing
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