HiTech Health awarded with €7m government funding for ‘disruptive’ project
HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund (DTIF), administered by Enterprise Ireland. This award will support the development of a novel treatment for Knee Osteoarthritis with the potential to regenerate the damaged knee joint whilst providing long-lasting pain relief.
Dr Brian Harrison, MD Hi-Tech Health, “We are excited to work with Relevium and Prof Garry Duffy’s team on the process development, scale up and GMP manufacturing of this novel therapeutic candidate at our Galway facilities. With all parties in the local area, we believe this will strengthen our partnership and help with developing this novel Knee Osteoarthritis therapy.”
Dr Alison Liddy, Founder and CEO Relevium, “This funding will enable Relevium and our partners to develop this ground-breaking treatment that has the potential to transform the lives of people living with Knee Osteoarthritis.”
Professor Garry Duffy, NUI Galway, “My team at NUI Galway are delighted to be part of this project and to work with industrial leaders to develop an impactful solution for Osteoarthritis.”
Temperature is a critical parameter in the transportation and storage of medicinal products. The temperature must be controlled and monitored from the manufacturing site through to the distributor and site of medicine use. When temperatures go outside the specified...
Many Cell and Gene Therapy (CGT) companies outsource product development and manufacturing activities to a Contract Development and Manufacturing Organisation (CDMO). It is critical to ensure that an informed decision is made when selecting a CDMO to prevent future...
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
HiTech Health and blood cancer charity Anthony Nolan have entered into an agreement to facilitate the development of novel cell and gene therapies.
Anthony Nolan Cell & Gene Therapy Services will support HiTech Health’s supply chain through the provision of a reliable, scalable source of high-quality starting material. Initially provision of cellular material will be for research and development (R&D) programmes with a view to scale up in the future to clinical application and manufacturing. The parties are open to collaboration with cell and gene therapy developers and will work with them to provide bespoke offerings specific to the client’s requirements.
Anthony Nolan Cell & Gene Therapy Services brings expertise in cell sourcing, selection and provision of high-quality starting material to complement HiTech Health’s end-to-end service from product development to manufacturing and launch of life-changing treatments.
In partnering we aim to support cell and gene therapy researchers and developers to bring life-saving treatments to patients who need them.
Diana Hernandez, Head of Immunotherapy Research at Anthony Nolan says: “This is a significant step towards establishing a sustainable chain in cell and gene therapy development as we move towards allogeneic therapies. This collaboration ensures supply of ethically sourced starting material to developers of new therapies, which we hope will improve the treatment and care of thousands of patients in the future. It also allows the parties to share information regarding quality attributes of the material, which can help inform future improvements.”
Aoife Duffy, Cell and Gene Therapy Operations Manager, HiTech Health says: “HiTech Health’s collaboration with Anthony Nolan will be a great benefit to our clients. Anthony Nolan’s reputation for supply of high quality starting materials provides assurance to our clients and collaborators that a robust supply chain is in place for the manufacturing and supply of Cell and Gene Therapy Products. With this collaboration with Anthony Nolan, we now have a supply of starting material that is crucial to enable manufacturing of these novel therapies. This collaboration adds to our current R&D experience and future expansion into GMP manufacturing. Our expertise in quality, QP approval, and management of product supply and logistics will also be an important role in this collaboration. We are very excited about this collaboration and are looking forward to the possibilities that we can achieve together with the ultimate goal of treating patients who have an unmet medical need.”
About Anthony Nolan Cell and Gene Therapy Services
Anthony Nolan is the pioneering charity that saves the lives of people with blood cancer and blood disorders who need a stem cell transplant. Anthony Nolan’s Cell and Gene Therapy Services aim to facilitate ethical research and development through the sourcing and supply of donor starting materials to researchers and developers. With a register of over 850,000 donors, a cord blood bank, and four decades of experience providing stem cells, Anthony Nolan has the infrastructure, the expertise, and the skills to support the needs of the cell and gene therapy industry
HiTech Health bring an in-depth knowledge and experience of Cell and Gene Therapy products, We offer a range of services to help develop and supply life-changing treatments. Our experts can provide comprehensive solutions and strategies for process development, supply pre-clinical products and quality control assay development. We also have the GMP experience and expertise including QP support to ensure GMP compliance and product release. We also have the demonstrated supply chain and logistics expertise to enable cell and gene therapy products to be imported into Europe and the UK.
HiTech Health, SextonBio and MedInstitute announce collaboration to develop and publish workflows for integrating unit operations in cell therapy manufacturing using flexible automation systems.
Sexton Biotechnologies, in partnership with HiTech Health and Med Institute, is working towards continued innovations in flexible automation. As cell and gene therapy manufacturers move to close and automate processes, the challenge of integrating existing systems is a pain point for the industry. Flexible automation of traditionally manual process offers a new solution with lower capital expenditures and greater potential for downstream success.
HiTech Health is focused on product development, manufacture, launch, and supply of cell and gene therapies. Aoife Duffy, Cell and Gene Therapy Operations Manager, leads a team that has successfully developed multiple cell and gene therapy products.
“We think it is important to collaborate with other companies so that we can add to our expertise in operational activities,” said Aoife. “Cell and gene therapy products are expensive to develop and manufacture. Working with Sexton and the Med institute to bring the new fluid management system to the market will help with making processing more efficient. HiTech Health is bringing our extensive operational and GMP Manufacturing expertise to this collaboration. We are expanding our capabilities to cell and gene therapy process development and manufacturing. Additional expertise we bring to the collaboration includes quality, QP approval, and management of supply chain. In the end, we believe that this collaboration will lead to time and cost savings, along with greater downstream success in the manufacture of cell therapy products.”
Read the Business Post article “HiTech Health is on a different level after refining elevator pitch” with HiTech Health’s Managing Director Brian Harrison by clicking on the link below:
Temperature is a critical parameter in the transportation and storage of medicinal products. The temperature must be controlled and monitored from the manufacturing site through to the distributor and site of medicine use. When temperatures go outside the specified...
Many Cell and Gene Therapy (CGT) companies outsource product development and manufacturing activities to a Contract Development and Manufacturing Organisation (CDMO). It is critical to ensure that an informed decision is made when selecting a CDMO to prevent future...
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
In early January 2020, HiTech Health officially obtained 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). This marks the successful application to the HPRA and audit conducted on-site at HiTech Health’s Dublin office. The newly received MIA licences for commercial products and IMPs is an opportunity for our clients to partner with us to provide them with EU Qualified Person (QP) and importation and certification services of medicinal products in the EU.
Commercial MIA
For all companies wishing to import and/or release batches of medicines in the EU , it is a legal requirement to hold a commercial MIA licence granted by a European country’s national regulatory authority. A commercial MIA licence is also required for repackaging or relabelling of medicinal products as well as any analytical retesting of imported finished product. HiTech Health are now in an excellent position to offer clients the opportunity to avail of our commercial MIA licence to certify medicinal products for release to the EU market. This offers the benefit of companies not having to substantially invest in the costly and thorough process of obtaining their own MIA licence which involves implementing a full quality management system (QMS). By partnering with HiTech Health, companies could potentially benefit from the three main advantages below:
Experienced cross-functional team to support clients every step of the way. HiTech Health employees have over 100 years of combined industry experience in Quality, Operations and Supply Chain and have a proven track record of delivering results for clients.
Financial savings: Instead of setting up an office and hiring a team of full-time employees in the EU, it is financially more cost effective to contract HiTech Health to provide the required quality services with no obligations for long-term commitments.
Timeline reduction: Developing a QMS and starting the MIA application process could take up to 12 months. Collaborating with HiTech Health can accelerate this lead-time to 3-4 months and help patients in a quicker time frame. After Brexit, Ireland is the only English-speaking country in the European Union.
Clinical Trials MIA (IMPs)
In addition to commercial drug batches, HiTech Health is now authorised to import and certify Investigational Medicinal Products (IMPs) for use in clinical trials within the EU. We can support the release and supply of IMPs to clinical trial sponsor sites throughout the EU in a cost effective and timely manner. After confirming a product has been manufactured and tested in accordance with EU GMP requirements, the HiTech Health MIA licence enables us to import and certify IMPs on behalf of clients allowing them to focus on their other core business activities. Our experienced in-house team have extensive knowledge of clinical trial sponsors and centres across Europe and can assist with supporting products to commercialisation.
Temperature is a critical parameter in the transportation and storage of medicinal products. The temperature must be controlled and monitored from the manufacturing site through to the distributor and site of medicine use. When temperatures go outside the specified...
Many Cell and Gene Therapy (CGT) companies outsource product development and manufacturing activities to a Contract Development and Manufacturing Organisation (CDMO). It is critical to ensure that an informed decision is made when selecting a CDMO to prevent future...
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
