Newsletter | June 10, 2019

06.10.19 -- "Work Harder" -- Ways To Completely Miss The Mark On Quality

  Antibody Fragment Capture With Next-Generation Protein A Resin

Following the wave of successful commercial monoclonal antibody products, various forms of antibody fragments are now becoming an important class of next-generation therapeutic proteins. However, due to the lack of an Fc region, these antibody fragments cannot be captured with most engineered Protein A affinity ligands. Amsphere™ A3 Protein A ligand, however, exhibits a high affinity for VHH single-domain antibodies. Click here to read more about Purification Of Antibody Fragments And Single Domain Antibodies With Amsphere™ A3 Protein A Resin.

Featured Editorial
“Work Harder” — And Other Ways To Completely Miss The Mark On Quality
By Ben Locwin, Ph.D.

Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect, in which they go along with the rhetoric because everyone else is.

The China Biosimilars Market: Rise Of A Potential Powerhouse
By Joseph Pategou

Since 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the U.S. How does the rise of the China biosimilars market fit this established picture?

Industry Insights
Is Your Biologic At Risk For Protein Aggregation? Part 1
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

The Upstream/Downstream Process Balancing Act
Article | By Serena Fries Smith and Hunter Malanson, Thermo Fisher Scientific

Early collaboration and open communication between upstream and downstream are crucial to ensure a consistent end-to-end bioprocess.

A Common Sense Approach To Sustainability In The Biosimilar Business
White Paper | By Ashok Kumar, IPCA

Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

Reference Methods For Packing Columns With IMAC Resin
Application Note | Bio-Rad Laboratories, Inc.

Reference methods for packing columns with Nuvia IMAC Resin: From Lab-Scale to Process Scale. This collateral details the packing of Nuvia IMAC in three different column sizes.

How Grünenthal’s Abuse-Deterrent Technology Combats Opioid Epidemic
Case Study | Thermo Fisher Scientific

While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. 

  2019 PDA/FDA Joint Regulatory Conference

The 2019 PDA/FDA Joint Regulatory Conference will highlight the evolving regulatory landscape and provide insight into how global companies are addressing regulatory challenges. Hear directly from senior FDA officials about program-specific initiatives and compliance updates. There will also be networking opportunities and an exhibition showcasing products and services to help improve your company’s product quality and manufacturing processes. Register now.

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