article thumbnail

Cell and Gene Therapy Bioassay – A Prerequisite for the ATMPs Development

Roots Analysis

Bioassay – A Prerequisite for the Cell and Gene Therapy Development. Therefore, increase in development of cell and gene therapy domain has led to the rise in demand of bioassay services for cell and gene therapy. Bioassays are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance.

article thumbnail

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. Drug discovery and development is an arduous process that can cost upwards of $2.6 billion and take over 10 years. This stage is more highly regulated and consists of both preclinical testing and clinical trials.

article thumbnail

Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

In vitro release testing to demonstrate bioequivalence. It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. Simplicity matters.