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.
Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
Temperature Controlled Transportation of Medicinal Products
Temperature is a critical parameter in the transportation and storage of medicinal products. The temperature must be controlled and monitored from the manufacturing site through to the distributor and site of medicine use. When temperatures go outside the specified...
Five Key Considerations When Selecting a Cell and Gene Therapy CDMO
Many Cell and Gene Therapy (CGT) companies outsource product development and manufacturing activities to a Contract Development and Manufacturing Organisation (CDMO). It is critical to ensure that an informed decision is made when selecting a CDMO to prevent future...
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.