GMP 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.
GMP Manufacturing
Our GMP facilities (EU GMP Approved) are specifically designed to manufacture sterile formulations and advanced therapies, providing you with end-to-end development and manufacturing services. The range of services include sourcing and supply of starting materials for products, offering GMP manufacturing, QC analytical and microbiological testing including rapid safety test methods (Sterility, Endotoxin and Mycoplasma) and the development of potency and release assays. Designing and performing stability studies, which are critical for product development and filing, are also available at the site. In addition we offer batch approval using our own Qualified Personnel (QP’s) for both the EU and UK.
We can support our clients with material importation and shipping of products. This includes cryogenic, cold chain and ambient shipments.
We also support our clients with regulatory documentation preparation, such as the Investigational Medicinal Product Dossier (IMPD) and CT Protocol.
Cell and Gene Therapies: 3 Key Supply Considerations
Personalised medicines involve an increased degree of complexity when it comes to manufacturing and supply in comparison to traditional pharmaceuticals. The Horizon 2020 Advisory Group defines personalised medicine as 'a medical model using the characterisation of...
EMA Regulation of Cell and Gene Therapies (CGTs)
Cell and Gene Therapy products and other Advanced Therapy Medicinal Products (ATMPs) have to comply with European Medicines Agency (EMA) legislation at different stages of the development process, including Good clinical practice (GCP), Good manufacturing practice...
Cell and Gene at the Abbey 2021 – Galway, Ireland
From 10th to 12th November, HiTech Health hosted ‘Cell and Gene at the Abbey’, a world-leading conference focusing on Production, Scale-up and Globalisation of cell and gene therapies. We would like to sincerely thank all the speakers, sponsors and attendees of this...
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.