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)
HiTech Health can provide an end-to-end development and manufacturing expertise for cell and gene therapies as well as small volume aseptic products. We operate our development laboratories to Good laboratory Practice (GLP) standards and under the same quality management system (QMS) which ensures a cost effective and streamlined partnership for the manufacture of GMP product for your clinical trials.
HiTech Health’s range of services include:
- GMP manufacturing for advanced medicines including cell and gene therapies.
- GMP manufacturing for sterile products (clinical scale volumes) including vial and bag filling.
- Full service from analytical and process development through manufacturing, Quality Control (QC) testing, packaging, batch release and distribution.
- Sourcing and supply of starting materials.
- Ambient, cold chain and cryogenic storage solutions.
HiTech Health Authorised by the MHRA to Perform Batch Importation and Certification of Investigational Medicinal Products (IMPs)
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
Cell Therapy: Points to Consider When Choosing a CDMO
At the Advanced Therapies Congress 2024 in London, Amina Al-Mossawi, a Qualified Person (QP) at Hitech Health, delivered vital insights on the crucial considerations for biotech firms when selecting a Contract Development and Manufacturing Organisation (CDMO). With...
Accelerating Regenerative Medicine : CCRM Australia and HiTech Health Announce Strategic Partnership
Hitech Health is delighted to announce its latest partnership with CCRM Australia, a not-for-profit organisation supporting regenerative medicine commercialisation in the Australian market. CCRM Australia works to accelerate the commercialisation of regenerative...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Contact us
Get in touch anytime – we are always available to discuss your upcoming projects.