Newsletter | January 6, 2020

01.06.20 -- FDA FY2019 Drug Inspection Observations And Trends

  Central Lab Market Dynamics And Outsourcing Performance (2019 To 2022)

This report will help study sponsors understand the service areas expected to grow in demand and the geographic trends associated with central lab service provider use to ensure study sponsors are up to date with how industry peers are outsourcing their central lab work. For providers, it will help determine the attributes and metrics critical to study sponsors in their selection of service providers to internally assess your lab’s capabilities in these areas. More.

Featured Editorial
FDA FY2019 Drug Inspection Observations And Trends
By Barbara Unger, Unger Consulting Inc.

This article presents the most recent publication of GMP drug inspection data from CDER, published November 15, 2019, and addresses drug inspections conducted in FY2019. We'll also take a look at seven years’ worth of trends in drug GMP inspections.

The Journey To Get An Ovarian Cancer T-Cell Therapy Into Clinical Trials
By Kevin Honeycutt and Erin Graham, Alliance for Cancer Gene Therapy (ACGT)

Daniel J. Powell Jr., Ph.D., and his research team at the University of Pennsylvania have launched a new clinical trial to treat ovarian cancer with a pioneering therapy involving genetically modified T cells. The trial, which has treated its first patient, almost didn’t happen.

Industry Insights
Bioreactors And Fermentors: Tools For Resolving Cultivation Bottlenecks
White Paper | By Ulrike Rasche, Eppendorf

In this white paper we explain the key characteristics of stirred-tank bioreactors and which organisms are typically grown in them.

Adoption Of Single-Use For Final Filtration
White Paper | By Terri Love and Youness Cherradi, MilliporeSigma

Moving from stainless steel to single-use assemblies for final filtration helps meet production demands and cut costs. Pre-use integrity and prototype testing and handling are important considerations.

LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance
White Paper | GE Healthcare Life Sciences

Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

How To Minimize API Loss: A Case Study In Aseptic Fill/Finish
Case Study | Argonaut Manufacturing Services

With API values continuing to climb as production scales conversely drop, it is time to rethink our aseptic filling processes to minimize API loss.

Choosing The Right CDMO For Late-Phase Clinical Trials
Webinar | Thermo Fisher Scientific

Your CDMO should be able to manage all clinical stages and have the expertise to move compounds from early-stage to late clinical stage and through process validation process to commercial launch.

A New High-Performance AEX Resin
Webinar | Bio-Rad Laboratories, Inc.

Designed for large biomolecule purification, this strong anion exchange resin features a rigid bead with large pores and optimized surface extenders. Dr. Jiali Liao presents case studies and design features.

Optimize Biologic Drug Development With The Power Of Scientific Informatics
Webinar | Dassault Systemes Americas

The complex structure of biologics and the nature of the interactions with their partners requires an accurate modeling method to predict their physicochemical properties.


Now in it's 12th year, the 2020 Disposable Solutions for Biomanufacturing Forum is the only global forum that focuses on the use of disposable products and single-use systems in biomanufacturing. 

Join us for three packed days of case studies and interactive sessions to identify new technologies, determine how to approach automated systems, how to transition to continuous processes, and how to implement best practices in system testing and life cycle management!

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