We can provide a full GMP manufacturing service for Advanced Therapeutic Medicinal Products (ATMPs) and offer quality and compliance services including QP release of products.
Our facilities are specifically designed to manufacture ATMPs where we can offer start to end manufacturing services. We can supply starting materials for ATMPS and offer manufacture, analytical and microbiological testing including rapid test methods and development of potency and other release assays. In addition we offer batch approval using our own Qualified Personnel (QP’s).
We can support our clients with material importation and shipping of quality samples as well as final product. This includes cold chain shipping of product.
We also support our clients with data preparation for use in their Investigational Medicinal Product Dossier (IMPD) regulatory filings.
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...
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