Monthly Spotlight - HiTech Health

HiTech Health's GMP Clean Room at their state-of-the-art laboratories in Galway

Cell and Gene Therapy: A New Wave of Medicines

Cell and Gene Therapy (CGT) is a new generation of precision therapy by altering the body's cells or genes within cells to treat or prevent diseases. It provides innovative therapeutic concepts and technologies for intractable diseases, such as cancer, rare diseases, and chronic disorders, with long-term therapeutic efficacy that is not possible with traditional medicines. With more than 15 cell and gene therapy products approved by the FDA since the approval of Kymriah in 2017, this supports the rapid development of cell and gene therapy as a new wave of medicines.

With over 1,000 ongoing cell and gene therapies clinical trials registered with ClinicalTrials.gov, these new therapies have the potential to change the lives of many people who have rare and life changing illnesses.

Figure 1. Simplified overview of Advanced Therapy Medicinal Products (ATMPs) - these are medicines for human use that are based on genes, tissues or cells.

HiTech Health is well positioned to assist organisations to be at the forefront of this new wave of medicine. Since its inception in 2013, HiTech Health has developed into a unique full-service Contract Development and Manufacturing Organisation (CDMO) in the cell and gene therapy space, offering a range of CMC services to enable companies to develop, manufacture and launch their products including Qualified Person (QP) and Responsible Person (RP) services.

However, their CGT expertise extends beyond services. HiTech Health is delighted to announce the addition of GMP Clean Rooms at their state-of-the-art laboratories in Galway, allowing for the manufacture of clinical materials, in addition to process and analytical development.

HiTech Health officially has both a Manufacturer’s / Importer’s Authorisation (MIA) licence for Medicinal Products for Human Use (commercial) and an MIA licence for Investigational Medicinal Products for Human Use (IMPs / clinical trials).

HiTech Health will be delighted to help with your product development, manufacturing and supply chain needs. Contact HiTech Health to learn more;

Visit www.hitech-health.com/ to learn more about HiTech Health's Cell and Gene Therapy Services
Follow HiTech Health on LinkedIn
Please email info@hitech-health.com to request further information on the range of services HiTech Health can provide