As cell therapies become more complex, the need for robust analytical tools to characterize such products as they enter the clinic has increased in kind, especially those related to flow cytometry.

Client programs using CHOMax follow platform-defined workflows and phase-appropriate practices across the development lifecycle.

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

The Center for Clinical and Translational Science (CCTS) is pleased to announce the latest recipients of CCTS Statistical and Analytic Methods Development support. This competitive program is designed ...

A platform approach to bioprocessing uses the same set of protocols and systems found during early phase development. Scientists then transfer the protocols, by either scaling-up or scaling-out, ...

Analytical research and development (AR&D) involves numerous processes required for drug development. AR&D includes processes such as reference standard qualification, validation of analytical methods ...

The Food & Drug Administration's recent approval of process analytical technology (PAT) for use in the pharmaceutical industry is being hailed by drug manufacturers because it encourages process ...

This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...

Bench to bedside, the Center for Clinical and Translational Science (CCTS) seeks to improve well-being and health in communities across the Deep South through collaborative partnerships and scientific ...

Process Development Scientists (process chemists) research and develop ways to manufacture products and monitor existing processes and products for quality and efficiency. A process development ...

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...