Cell and Gene Therapy CDMO Services
YOUR TRUSTED AND RELIABLE CDMO PARTNER FOR ADVANCED THERAPIES
We are a GMP-certified Contract Development and Manufacturing Organisation (CDMO) for advanced medicines including cell and gene therapies. With our in-depth knowledge and experience of a diverse range of advanced therapies, our team can support from preclinical development through GMP manufacturing and supply of advanced therapies to patients.
Qualified Persons (QPs)
We have a deeply experienced team of Qualified Persons (QPs) across the EU and UK to support with batch importation and QP release of your advanced therapy. Our QP team are committed to helping you conduct clinical trials and launching commercial therapies.
GMP Cell & Gene Therapy Manufacturing
HiTech Health is a GMP manufacturer of advanced therapies including cell and gene therapies. Our team can provide an end-to-end GMP manufacturing service and support with final product release by our in-house QPs.
CDMO Sterile Manufacturing - Aseptic Fill-Finish
HiTech Health offers clinical scale fill-finish services, including vial and bag filling in our GMP state–of the–art cleanroom facilities in a strategic EU location.
Packaging, Labelling, Storage & Distribution
HiTech Health provides solutions for clinical packaging, labelling, storage and distribution of your advanced therapy.
Supply Chain Management
We provide Good Distribution Practice (GDP) compliant supply chain management services. This including management of temperature controlled shipments, Importer / Exporter of Record (IoR / EoR) solutions, and EU Responsible Person (RP) services.
QC, Analytical Testing and Process Development
Quality Control (QC), analytical testing and process development support for your advanced therapy. Our GMP facility is equipment with state-of-the-art equipment to support your product testing requirements.
