Newsletter | June 24, 2019

06.24.19 -- The Biopharma Pipeline Is Strong, But Are New Innovations Reaching Patients?

 
Featured Editorial
Is Biopharma's Strong Pipeline Poised To Reach Patients?
 
By Eduardo Schur, Justin Zamirowski, Atin Patel, and Maya Desai, Navigant

The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5 percent. The pipeline is strong, but how many innovations are actually reaching patients?

7 Tools For Breakthrough Quality And Performance In 30 Days
By Ben Locwin, Ph.D.

In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the “7 Tools of Quality.”

Industry Insights
A New Process For Reducing Glass Breakage
Article | By Mads Reedtz Espersen, Novo Nordisk

Glass breakage is commonly acknowledged as a major nuisance in parenteral manufacturing. It causes a plethora of problems, such as disruption of production, particle contamination, and loss of sterility.

Achieving Unique Synergies In Antibody Expression
Poster | By Rachel Kravitz, Wendy Vredenburgh, Victoria Chrostowski and Greg Bleck, Catalent

Combining Catalent’s GPEx cell line development technology with the Berkeley Lights, Inc. Beacon platform for clonal cell line selection resulted in stable, higher-expressing clones in a shortened timeframe.

Development Of Binding Assays To Measure Interactions Between Fc Regions Of Therapeutic Monoclonal Antibodies And Fc Receptors Using Surface Plasmon Resonance
Poster | By Deepa Raghu, Yu-Ting Hsu, Ludmila Kelly, Pamela Hamill, and Marian McKee, MilliporeSigma (Product Characterization)

It's crucial to evaluate the binding interaction of monoclonal antibodys (mAbs) with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.

10 Questions To Ask Your Clinical Supply Vendor About Temperature-Sensitive Drugs
White Paper | Thermo Fisher Scientific

Keeping investigational products at the right temperature and environmental conditions takes careful coordination of resources and, when required, tight integration with an experienced vendor.

Freezing Cellular Raw Materials For Cell Therapy Production
Article | GE Healthcare Life Sciences

Key Biologics is harnessing new freezing technology to help deliver the future of medicine. Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies.

Evaluation Of Chromassette Packed With Cation Exchange Resin
Application Note | JSR Life Sciences

A modular chromatography technology that readily meets today’s bioseparation scale-up demands for improved ease of use.

Solutions
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HyPerforma G3Lab Bioprocess Controller
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