blog
The SoHO Regulation: A Step Forward in European Health and Safety
The European Union has recently introduced a landmark regulation aimed at enhancing the safety, quality, and accessibility of substances of…
Case study
How to Optimize CMC for Successful Cultured Meat Product Development
Cultured meat products are novel in the market, there are no regulatory and CMC guidelines specifically dedicated to them. Therefore,…
Case study
Key CMC Challenges for Innovative Healthcare Products
Have you encountered CMC challenges in the development of your innovative healthcare product? CMC includes all activities vital to product…
blog
Critical Materials considerations for Cell and Gene therapy product development – Part 2
In Part 1 of this blog, we covered the definitions of Starting Materials, Raw Materials, and Ancillary Materials. In Part…
blog
Critical Materials considerations for Cell and Gene therapy product development – Part 1
Raw and starting materials are an essential part of cell-based and gene therapy products (CGT). Frequently, the development of Cell…
whitepaper
Overcoming Regulatory and CMC Technical Challenges of Microbiome Product Development
In this white paper we provide a fleeting look at some of the CMC ‘building blocks’ that can be assembled…
