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.
EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of...
HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA
Hitech Health's Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate's Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for...
Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head...
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.