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

Roots Analysis

Bioassay – A Prerequisite for the Cell and Gene Therapy Development. Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. Bioassays are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance.

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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.

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

Pharmaceutical Technology

Formulating products that have the proper composition, viscosity, texture, and stability, and can also be shown to be safe and effective, is both a science and an art. Without proper precautions, knowledge gaps can occur and important details may be overlooked when a product is transferred from one site to another. Simplicity matters.