Newsletter | February 6, 2020

02.06.20 -- Have Biosimilars Lived Up To Their Promise?

  Webinar: 2019 Year In Review

ISR is a market research firm operating exclusively in the pharmaceutical manufacturing and clinical research space. In 2019, they conducted approximately two dozen individual pieces of market research for syndication. This webinar will summarize many of the important learnings from these projects, providing attendees with real, usable data for 2020 activities.

Featured Editorial
Sandoz Executives: Have Biosimilars Lived Up To Their Promise?
By Anna Rose Welch, editor, Biosimilar Development

In the first part of this two-part article, I picked two Sandoz executives' brains about the progress they’ve observed and how challenges for the industry have evolved over the past 10 years.

6 Important Elements Of The New STRONGER Patents Act
By John Serio, Burns & Levinson

Over the past decade, patent reform has been an area of emphasis for Congress. This article explores several of the main tenets of the STRONGER legislation, which biologics and biosimilar makers should be aware of as the Inter Partes Review (IPR) currently remains a critical part of patent litigation today.

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.

Key Steps To Ensure Optimized And Reproducible qPCR Experiments
Article | Bio-Rad Laboratories, Inc.

Real-time quantitative PCR (qPCR) is a powerful and commonly used method for quantifying gene expression. It is an accessible technology that can be quickly learned. However, by keeping a few key steps in mind as you plan and run your real-time PCR (polymerase chain reaction) experiments you can optimize your qPCR experiments and ensure high-quality data and reproducible results.

Process Effects On Drug Product Quality In Pharmaceutical Manufacturing: A Validated Measurement Process
White Paper | GE Healthcare Life Sciences

This white paper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes and how a systematic approach with validated SPR (surface plasmon resonance) assays can help in this respect.

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