Newsletter | September 16, 2019

09.16.19 -- Does Gender Disparity In Biotech Really Matter?

Webinar: Smarter Process Development Of Chromatography Steps

Presented by Peter Hagwall, Product Strategy Manager, Process Development Tools, GE Healthcare
September 24, 2019 | 11:00 am EDT

In this webinar you will learn three ways to help you reduce process development timelines and improve outcomes.
• In-silico process development and data-driven decisions
• Management of process variability through deeper process understanding
• Use of high-throughput methodologies

Register Now.

Featured Editorial
Does Gender Disparity In Biotech Really Matter?
By Matthew Pillar, editor, BioProcess Online

Why it does, and how one startup is winning the biotech talent wars with a diversity-centric strategy.

Negotiating Quality Technical Agreements: Strategies For Non-Quality Professionals
By Ray Sison, xCell Strategic Consulting, LLC

Of the four critical documents that must be negotiated and executed by both sponsor and CDMO (NDA, quotation, MSA/SA, and QTA), the QTA (quality technical agreement) is often the least-prioritized by the procurement team. Yet, in practice, the QTA will be the most useful for development- and clinical-stage companies, because it provides a framework for operations and a road map for building quality systems.

Industry Insights
5 Qualifying Questions To Evaluate Temperature-Controlled Shipping Solutions
Article | By Travis Hudson, Singota Solutions

Life sciences companies with complex warehousing and shipping requirements have a lot of questions. Here are the questions to ask to identify a logistics vendor with the right competency.

Chromatography Scale-Up: Don’t Get Tied Down By Bed Height
Article | By Kerstin Erickson, GE Healthcare Life Sciences

When scaling, you can make better use of existing chromatography columns while avoiding overcapacity. Try this alternative approach to achieve a constant residence time.

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.

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)

An important characteristic of an antibody is its Fc effector function, and antibodies are now being engineered for optimal binding to Fc receptors expressed on effector cells. Hence it is crucial to evaluate the binding interaction of monoclonal antibodies (mAbs) with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.

Now And Next: Mavupharma
Q&A | Jubilant Biosys

Saurabh Kapure, vice president, business development, USA for Jubilant Biosys, recently sat down with Michael Gallatin, Ph.D., president and cofounder of Mavupharma (Mavu), the drug discovery and development company, to discuss some of the latest developments in the industry and at Mavu. In this Q&A, Dr. Gallatin shares his thoughts about Mavupharma, his role at the company, the evolution of biopharma, drug discovery, development, and the road ahead for the industry.

A Highly Reproducible In Vivo Model For Bleomycin-Induced Lung Fibrosis In Mice To Evaluate Drugs For The Treatment Of IPF
White Paper | GVK Biosciences

Bleomycin-induced pulmonary fibrosis has been a useful preclinical model in several species and is most prevalent in rodent models to evaluate potential prophylactic and therapeutic drugs for IPF. Major drawbacks for this model have been its mortality rate and inconsistency in the induction of the disease. Access to a large portfolio of in vivo fibrosis models allowed for successful drug testing.

Capturing Market Share Through Geriatric, Pediatric Product Line Extension
Webinar | Thermo Fisher Scientific

During this webinar, Pharma Services' Kaspar van den Dries, senior director, formulation sciences, and Helena Teles, formulation development manager, discuss how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations. They share concepts, regulatory considerations, and case studies around the development and commercialization of the chewable softgel capsule for these different market segments.

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