Case study
Creating a complex IND whilst safeguarding confidential data between a CGT spin-off and CDMO
When submitting and IND for CGT product/therapy, it’s crucial to confirm that the viral vector in use is appropriate, especially…
blog
Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene…
In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
webinar
Key CMC and NC considerations for cell and gene therapy development
ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US,…
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…
webinar
Patient access to Advanced Therapies in Europe 2009-2021: from early access failures to current challenges
The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its…
blog
Advice on Non-clinical and Clinical Development for ATMPs from an Ex-CAT member
Gene Therapies and Cell-based products, referred to as Regenerative Medicine Advanced Therapy (RMAT) in the USA and as Advanced Therapy Medicinal…
