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.
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.
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.
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.
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.