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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. 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.

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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Due to the high costs associated with new drug development, pharmaceutical companies are under pressure to get effective drugs to market as fast as possible while ensuring they are safe for the intended patient population and dosing timeline, which can be lifelong for some drugs. billion and take over 10 years.

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

Pharmaceutical Technology

It is important for a CDMO to understand the market it serves and, in the dermatologic arena, that means the demand for topical agents across a broad array of indications. In vitro release testing to demonstrate bioequivalence. Expertise in analytical testing, validation, and quality control are also essential. Simplicity matters.