TCAT at SNBTS
End-to-end solutions for Advanced Therapies.
About Us
An established developer and manufacturer of cell therapy products.
SNBTS have over 20 years’ experience delivering autologous and allogeneic products for in vivo studies and First in Human, Phase 1 and Phase 2 trials.
We also manufacture Cell Banks of somatic stem cells, hESC and iPSC lines.
As a NHS establishment we are uniquely positioned to support academic and other early-stage developers in the translation of their ‘proof of concept’ stage products into GMP-compatible processes, and to manufacture these products for early-stage clinical trials.
We have proven expertise working with somatic cells, pluripotent stem cells and their derivatives, and genetically modified cell therapies.
Alongside our GMP capability we have extensive in-house Quality Control capacity specifically developed for Advanced Therapy Medicinal Products (ATMPs), including endotoxin and sterility, cell identity and function, and stability studies.
Services
For over two decades we have maintained an international reputation as a leading developer and manufacturer of Advanced Therapy Medicinal Products.
End-to-end solutions
We offer a full range of consultancy, development, translation, CMC (chemistry, manufacture and control) and GMP-manufacturing services that can be tailored to your requirements.
Bespoke
We work with you in the way that you prefer, integrating with your team or acting as a stand-alone problem-solving partner.
Just starting out?
We offer ATMP-specific Research and Development, Quality Control (both sterility and cell identity testing), and manufacturing to early-stage developers who are not yet able to invest in their own in-house teams and facilities.
Take a closer look at how we can help you
From research data via proof of principle to clinical manufacturing
Development and Translation
GMP Quality and Manufacturing
GMP Sterility Testing
How we work
Our ethos is underpinned by the principles of safety, quality and efficacy.
SNBTS has an extensive track record of working with scientists, clinicians, and early-stage companies to technology transfer candidate ATMPs from a research setting into our facility, industrialise the cell production process, develop an accompanying analytics package, and train the final production / Quality Control package into the cleanroom setting for routine GMP-manufacture.
We have hands-on experience of working with different groups, across many different products including somatic cells, pluripotent stem cells and their derivatives, and genetically modified cell therapies, often at various stages
of development.
This means that SNBTS teams are highly adept problem solvers who are able to bring futureproofing expertise to projects from the outset.
We can integrate with your team to complement your expertise, supplement knowledge gaps and solve problems, act as a stand-alone service delivery partner, or something in between.
Facilities
Based in Edinburgh, we have two state-of-the-art GMP manufacturing facilities available as part of our service.
Our Microbiology Quality Control testing facility is located at the Pentlands Science Park, with cell / product characterisation Quality Control services co-located with our production cleanrooms at both the Jack Copland Centre and the Institute for Regeneration and Repair North, meeting the testing requirements for both fresh and cryopreserved products.
All of our Quality Control services – both Biological and Microbiological testing – are licenced appropriately by the MHRA.
Jack Copland Centre
Our main facility on Edinburgh’s Heriot Watt Research Park.
Institute for Regeneration and Repair – North
Our second facility within the Edinburgh BioQuarter.
Workforce
Translation Scientists
Our dedicated Development team of Translation Scientists, of whom 70% are PhD qualified, are responsible for industrialising the manufacturing process and analytics for transfer into the GMP cleanroom.
Production and Quality Control Scientists
More than 25 GMP-Production Scientists, GMP-Quality Control-Analytics Scientists, and Training and Compliance Officers supporting the manufacture of GMP products for clinical trial and patient use.
Operations Team
Support is provided by an Operations team responsible for project management, a specialist Quality Assurance and Regulations team, and a Quality Control-sterility team.
Licensure
SNBTS holds a range of licences enabling us to provide an end-to-end service from blood and tissue procurement to clinical product.
Blood Components
Blood Safety and Quality Regulations 2005 (as amended)
Blood Establishment Authorisation
Tissues and Cells
Human Tissues (Quality and Safety for Human Application) Regulations 2007 (as amended)
Human Tissue (Scotland) Act 2006 (as amended)
Human Tissue Authority (HTA) licence
Advanced Therapy Medicinal Products
Human Medicines Regulations SI 1916/2012 (as amended)
MIA, MIA(IMP), MS and GMP testing licences (MHRA)
Gametes and Reproductive Tissues
Human Fertilisation and Embryology Act 2008
HFEA licence
Where to find us
Contact us
Jack Copland Centre
52 Research Avenue North
Edinburgh EH14 4BE
Institute for Regeneration and Repair – North
5 Little France Avenue
Edinburgh EH16 4UU