GMP Cell & Gene Therapy Manufacturing
We can provide a full GMP manufacturing service for sterile formulations and advanced therapies, including cell and gene therapies. Our team provide quality and compliance services including QP release of products.
Cell and Gene Therapies & Small Volume Aseptic Products
Contract Development and Manufacturing Organisation (CDMO)
Our GMP facilities are specifically designed to manufacture sterile formulations and advanced therapies, providing you with end-to-end development and manufacturing services. HiTech Health’s range of services include:
- GMP manufacturing for advanced medicines
- Batch approval for EU & UK
- Sourcing and supply of starting materials for products
- Ambient, cold chain and cryogenic storage solutions
HiTech Health’s capabilities extend to clinical scale sterile filling of vials and bags, providing end-to-end solutions from formulation to final packaging in a controlled aseptic environment. Our GMP facility ensures the highest quality and compliance for pharmaceutical and biologic products, meeting stringent regulatory standards.
Cell and Gene Expertise
Our Cell and Gene team have extensive experience supporting a wide range of cell types for research, development, and GMP manufacturing including:
- Induced Pluripotent Stem Cells (iPSCs)
- T Cells, including Regulatory T Cells (Tregs)
- Natural Killer (NK) Cells
- Peripheral Blood Mononuclear Cells (PBMCs)
- Mesenchymal Stem Cells (MSCs)
- Primary tissues (fibroblast and blood processing)
- We also support a broad range of other cell types.