Newsletter | May 22, 2019

05.22.19 -- Aseptic Technique Training: How To Avoid The Pitfalls

  Bioprocessing Market Trends And Outsourcing Dynamics

This report affords readers the opportunity to gain insight into the bioprocessing market and where it’s heading. It provides an overview of the current market dynamics for bioprocessing as well as an outlook on what our survey respondents predict the marketplace will look like in five years. You can purchase the full report or download a free preview by clicking here.

Featured Editorial
Training Production Operators In Aseptic Technique: Common Pitfalls And How To Avoid Them
By Paula Peacos, ValSource, Inc.

Retraining an operator involved in a microbiological excursion is almost always part of the corrective and preventative action (CAPA), yet repeat excursions and deviations due to improper aseptic technique still routinely occur. So, why do some operators still have difficulty executing the task after completing such intensive training programs?

How The Purple Book Continuity Act Could Challenge Biosimilars And The FDA
By Kate Cook, Greenleaf Health

The Purple Book Continuity Act of 2019 represents a laudable effort to build on the FDA’s initial work in establishing the Purple Book and supporting the development of biosimilars. However, efforts to address data standards for biosimilars or to include patent listings in the Purple Book are misplaced.

Industry Insights
Using A CMO To Streamline Process Characterization
White Paper | By Evan Pasenello and Daniel Sayut, AbbVie

While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

A "QUICK" Guide To Selecting A CMO
Article | By Brittany Cloud, Eurofins Medical Device Testing

A thorough and systematic process to holistically gauge the attributes of a firm that are critical to creating an effective outsourcing relationship.

Cell Growth Performance In Single-Use Bags
White Paper | Sartorius Stedim Biotech

Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trend are towards higher cell densities and protein titers.

Converting From ELISA To Biacore SPR Assays
Application Note | GE Healthcare Life Sciences

Biacore SPR assays provide an automated and reproducible real-time determination of active concentrations that can be considered an alternative to traditional ELISA approach. This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR assay and, by doing so, shows how you can get results in less than half the time compared with ELISA.

Benefits Of Mixed-Mode Cation Exchange Chromatography
Application Note | Pall Biotech

This note addresses the performance of Pall’s mixed-mode cation exchange (CEX) CMM HyperCel sorbent, which can be applied to both monoclonal antibody (mAb) polishing and recombinant protein purification.

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