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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. In fact, from year 2016 to 2020 more than 300 IND filing for cell and gene therapy product have been recorded, indicating that several developers and innovators are more attracted towards the cell and gene therapies.

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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Drug discovery and development is an arduous process that can cost upwards of $2.6 Drug discovery and development New pharmaceutical small molecule drugs require extensive safety testing before the manufacturer can obtain regulatory approval for use in humans. 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 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. Optimising development and scale-up. Simplicity matters. Particle distribution.