Newsletter | October 21, 2019

10.21.19 -- CAR T-Cell Therapies: Current Limitations & Future Opportunities

 
Featured Editorial
CAR T-Cell Therapies: Current Limitations And Future Opportunities
 
By Anamika Ghosh, Ph.D., and Dana Gheorghe, Ph.D., DRG Oncology

Novel technologies to address areas left unaddressed by Kymriah and Yescarta have started streaming into the research arena. This article focuses on the barriers to widespread commercial adoption of the currently available CAR-T cell therapies and opportunities for developers of next-generation treatments.

FDA’s New Population Pharmacokinetics Guidance: What You Need To Know
By Scott Thiel and Liisa Eisenlohr, Navigant

The FDA’s Population Pharmacokinetics Guidance for Industry draft calls for sponsors of new drug and biologics license applications to apply population pharmacokinetics (PK) analysis. This column covers the implications for drug and device manufacturers.

Industry Insights
Smoke Signals: One Plant’s Secret For Assuring Aseptic Control
White Paper | By Tony Pavell, Fresenius Kabi

Airflow visualization testing, conducted as part of a routine review program, can help assure that aseptic filling areas remain under a state of proper control.

Managing Demand Uncertainty In Biologics Production
White Paper | By Stephen Lam and John Ward, Thermo Fisher Scientific

How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

Single-Use Process Platforms Help Biomanufacturers Reduce Costs
White Paper | By Miriam Monge, Sartorius Stedim Biotech

Enhanced flexibility and reduced operating costs are being achieved through the widespread adoption of single-use technology either as part of completely single-use processes or as hybrid solutions.

Purification Of Antibodies With Hydrophobic Anion Exchange Resin
Case Study | By Xuemei He, Louisa Vang, Mark Syder, Payal Khandelwal, and Daniel Yoshikawa, Bio-Rad Laboratories, Inc.

A hydrophobic anion exchange mixed-mode resin has been developed to overcome challenges in antibody purification. This application note describes the purification of acidic and basic antibodies using this mixed-mode chromatography resin through bind-elute and flow-through modes of purification.

Improved Bioavailability Of Trio Medicines In 12 Weeks
Case Study | Catalent

Learn how a structured three-step approach can help overcome the challenge of molecular characterization and a limited budget.

3 Development Principles For Advanced Biopharma Tubing: Part 1
White Paper | Meissner Filtration Products

Tubing is one of the earliest components in the pharmaceutical industry to be associated with single-use technology (SUT). The development principles in this paper ensure active risk mitigation and cleaner materials in single-use tubing applications.

Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics
White Paper | GE Healthcare Life Sciences

Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, such as surface plasmon resonance, can help circumvent these issues and optimize development.

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