Cell and Gene Therapy
We are a Contract Development and Manufacturing Organisation (CDMO) for advanced medicines including cell and gene therapies. With our in-depth knowledge and experience of Cell and Gene Therapy products, HiTech Health offer a range of services to help develop and supply life-changing treatments.
Process and Analytical Assay Development
Our experts can provide comprehensive solutions and strategies for process development, supply pre-clinical products and quality control assay development.
Qualified Persons Specialising in CGT
Ensuring you have the right person to release your product to the clinic is essential for success and HiTech Health can support you with this critical role.
Audits of CDMOs and Contract Testing Laboratories
Let us help you to perform an independent audit of your key manufacturer or testing laboratory to ensure you are receiving a quality service.
One of the biggest bottlenecks in the CGT space is finding the right people. HiTech Health offer a unique range of personalised training in the CGT space.
Supply Chain Assessment for CGT
Cell and gene therapies are distinctly different from traditional biopharma product and their supply chains require uniquely designed logistics solutions.
We can provide a full GMP manufacturing service for ATMPs and offer quality and compliance services including QP release of products.
Clients & Collaborators
Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities...
HiTech Health presented at the 3rd Global Bioprocessing, Bioanalytical, and ATMP Manufacturing Congress in Dublin, Ireland
HiTech Health are delighted to have attended the 3rd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress on 16th and 17th May. HiTech Health’s Quality and Compliance Lead Julie-Anne O'Neill and Manager of Cell and Gene Therapy Operations Aoife Duffy...
On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
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