Charles River Laboratories International has officially opened the doors of its Alderley Park site in Cheshire, UK, a purpose-built High Quality (HQ) plasmid manufacturing facility to support the development of potentially transformative cell and gene therapies (C>s).
Key highlights:
- The UK is one of the leading countries in the C> space, with a total UK investment in ATMPs for human use totalled at £3.8bn.
- The facility, based within the Alderley Park campus, is the latest in Charles River’s growing global CDMO network.
- Charles River offers three grades of plasmid DNA, research, HQ and GMP, to for a seamless transition to a program development journey.
To meet increasing demand for C>s with accelerated clinical development, there is a need for manufacturers to rapidly supply phase-appropriate plasmid DNA, a critical starting material, to therapeutic developers. Charles River offers three grades of plasmid DNA, research, HQ and GMP, to transition seamlessly throughout your program development journey.
HQ plasmid is manufactured by Charles River to the principles of GMP, with the added benefit of a 5+ week turnaround from initiation to release, reducing time to clinic.
With an established quality infrastructure and 20+ year track record, the facility, based within the Alderley Park campus, is the latest in Charles River’s growing global contract development and manufacturing (CDMO) network. The site will help ensure demand for these DNA vectors can be met, furthermore supporting the growth of the industry in the UK.
Niall Dinwoodie, executive director, Gene Manufacturing Europe, Charles River: “The new 16,000 square foot facility expands our capabilities and will help fast-track the process of bringing therapies to market, address global supply shortages and support therapeutic developers through rapid access to material. As new gene therapies are launched around the world with the potential to change lives, our investment is a further vote of confidence in the future of this exciting and transformative industry here in the UK.”
UK C> Industry
The UK is a global leader in the C> space, with the largest cluster of therapeutic development companies outside the US. UK investment in ATMPs for human use totalled at £3.8bn, resulting in nine therapies reimbursed and reaching patients, and 38 therapies in Phase III of clinical development at the end of 2021. By 2035, the UK is expected to have a 15% share of C> global market activity, contributing £10bn in revenue and providing 18,000 jobs.
Matthew Durdy, CEO, Cell and Gene Therapy Catapult: “The funding and launch of the new Charles River facility represents a powerful and vital addition to the national manufacturing network and marks a huge step forward for the UK’s infrastructure needs. The rapid expansion of our manufacturing capabilities is fundamental both to meeting the growing global demand for ATMPs and developing the UK’s standing as a leading international hub for cell and gene therapy.
“Overcoming key challenges to further open up local and international market opportunities remains crucial to the sector’s continued growth. Moreover, world class manufacturing technology and robust supply chain solutions become increasingly pivotal as the market evolves to target these life-changing therapies at high prevalence diseases. Capabilities such as those now established at Alderley Park, are central to addressing these challenges and to ensuring that the UK continues to excel and be a global leader in cell and gene therapies.”
Cell and Gene Therapies
C>s utilise genetic material, or live cells, to treat or potentially cure a disease, and can allow for the creation of highly personalised therapies, with approved products already on the market for indications such as multiple myeloma, retinal dystrophy, and Spinal Muscular Atrophy (SMA). Advanced Therapy Medicinal Products (ATMPs) are widely regarded as having the potential to change the way we manage difficult, life-changing conditions including various cancers and neurological diseases such as Parkinson’s and Alzheimer’s, also demonstrating their importance in the development of COVID-19 vaccines.