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
New FDA ‘Super Office’ created for Cell and Gene Therapy Products
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
Importation of Medicinal Products: Understanding the EU requirements
The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in...
PMTC Spotlight – HiTech Health
HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight. HiTech Health is a full-service Contract Development and Manufacturing...
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