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. 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.

article thumbnail

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.

article thumbnail

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

Pharmaceutical Technology

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Optimising development and scale-up. Particle distribution. Grittiness.