Cell and Gene at the Abbey 2021 – Galway, Ireland

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 year’s conference and are already looking forward to hosting the event in 2022.

Over the course of 3 days at the beautiful setting of the Glenlo Abbey in Galway, there were amazing insights from global leaders in the cell and gene therapy space. Overcoming production and supply chain challenges was a key focus with speakers from around the world attending the event. The exciting list of speakers included Power List 2020 in Advanced Medicines featured experts Bruce Levine, Massimo Dominici and Qasim Rafiq who spoke about development and regulatory approvals, challenges in scaling up, supply chain and manufacturing and the opportunities to solve them. An update on the European regulatory environment for Advanced Medicines from Niamh Curran of the HPRA was of benefit to all.

Attendees were able to see first-hand some of the latest technologies in cell processing technologies from many of  the event’s sponsors Cellexus, ChemoMetec, Miltenyi Biotec, Sexton Biotechnologies, Terumo, VivaBioCel, AccuScience and MeiraGTx. Cell and Gene therapies are at the forefront of regenerative medicine and HiTech Health are continuing to grow rapidly in this sector. Find out how we can support you on your development and commercialisation journey by contacting us today.

HiTech-Health awarded with government funding

HiTech-Health awarded with government funding

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.”

Relevium Medical awarded with government funding

HiTech Health awarded with government funding

NUI Galway awarded with government funding

Read the full Irish Times article here: Government to provide €95m in funding for ‘disruptive’ projects

Find out more about Relevium: www.relevium-medical.com

Find out more about NUI Galway: www.nuigalway.ie/medicine-nursing-and-health-sciences/

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HiTech Health and Anthony Nolan announce collaboration

HiTech Health and Anthony Nolan announce collaboration

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

Website: www.anthonynolan.org/clinicians-and-researchers/cell-and-gene-therapy-services
LinkedIn: www.linkedin.com/showcase/anthony-nolan-cell-&-gene-therapy-services/
Contact: Katie Griffee, Business Development Manager – katie.griffee@anthonynolan.org

About HiTech Health

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.

Find out more about Cell & Gene Therapy: www.hitech-health.com/cell-and-gene-therapy/
Find us on LinkedIn: www.linkedin.com/company/hitech-health
Contact: Aoife Duffy, Cell & Gene Therapy Operations Manager – aduffy@hitech-health.com

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HiTech Health, SextonBio and MedInstitute announce collaboration

HiTech Health, SextonBio and MedInstitute announce collaboration

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.”

Click here for more details.

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Brexit Deal: Ensuring Continuity of Drug Supply

Brexit Deal: Ensuring Continuity of Drug Supply


On the 24th December 2020, a Trade and Cooperation Agreement (TCA) was struck between the EU and UK. This is welcomed by the pharmaceutical industry as it helps with maintaining continuity of supply and flow of medicinal products as well as other products between EU and the UK.

From a high-level perspective there will be significant changes to customs procedures which came into effect from the 01st January 2021. The most catastrophic disruption of a no deal scenario has been avoided and companies can now begin to invest in long-term future supply plans. One of the challenges companies now face is that they have had little time to adjust to the conditions of the deal which may cause initial delays and errors in certification, importation/exportation documentation, and transportation of medical products between the UK and EU and vice versa. The trade deal has significant consequences for the movement of medicinal products both to and from the EU. Let us have a look at these in more detail.


UK companies supplying product to the EU

The three primary areas where businesses should keep an eye out for changes include Transportation and Shipping, Regulatory and Quality and Compliance. Here is what you need to know.

Shipments of medicinal products from the UK to the EU no longer fall under the free movement of goods and therefore are categorised as a cross-border activity. There will be a requirement for additional paperwork such as customs declarations. Companies may need to use brokerage service providers which may result in an increased end user price of the product. Fortunately, the deal means there will be no tariffs placed on any products. UK companies will need to engage EU businesses to act as the Importer of Record (IoR) for products moving from the UK to the EU. It will be extremely important to ensure the correct paperwork is in order for shipments going forward, especially for products with a very short shelf that are being transport under strict time and temperature constraints.

From a regulatory perspective, there are two important things to note. Marketing Authorisation (MA) holders, if held in the UK, will have to be transferred to an EU or EEA country. Secondly, for products that are being imported from the UK to the EU, the EU site of batch release must be named on the MA.

Each batch of UK manufactured drug product intended for the EU/EEA market will need to be imported to a site of physical importation and released by a QP operating under an MIA within the EU/EEA. Until a Mutual Recognition Agreement is in place between the EU and UK, each batch of finished medicinal product must undergo, in an EU Member State, a full qualitative analysis, a quantitative analysis of all the active substances. Pharmacovigilance of drug products placed on the EU/EEA market will need to be managed from a location within the EU/EEA. This means the Qualified Person Responsible for Pharmacovigilance (QPPV) must also reside and operate in the EU/EEA from 1st January 2021.


EU companies supplying product to the UK

Transportation and shipping changes for EU companies supplying product to the UK looks similar to what was mentioned above with additional paperwork including customs declarations being the critical requirement going forward.

If EU companies wish to conduct clinical trials in the UK, the UK regulatory authority will require that exported product to the UK have a certification by a UK QP before it can be administered to a patient (1).

If you are the Sponsor of a UK clinical trial using IMPs imported from into the UK from countries on the ‘approved country for import’ list (initially, all EU and EEA countries) you will require a UK Manufacturing and Import Authorisation (MIA (IMP)) holder to put in place the assurance system to check these IMPs have been certified by a Qualified Person (QP) in a listed country, before being they are used in a clinical trial setting (1). IMPs will not require recertification, however. A wholesaler may only import certified medicines from the EU if the appropriate checks are made by the UK Responsible Person (RP). The RP must reside in the UK, as well as a number of other factors which can be found on the MHRA website (2). It is therefore important to engage with the right personnel in order to successfully put in place the infrastructure necessary to continue to supply medicinal products between the EU and the UK.

For more information on QP batch certification and importation, Importer of Record (IoR) and Responsible Person services, please contact the author Robert Hanly at rhanly@hitech-health.com or email info@hitech-health.com.

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EU Market Access for UK Companies

EU Market Access for UK Companies

EU Market Access for UK Companies

The UK life sciences industry contributes over £30 billion to the UK economy, and supports almost half a million UK jobs. The UK is a leading centre of medical research and biopharmaceutical innovation and is at the forefront of drug development and approval. With the Brexit transition period ending in less than six weeks, the UK pharmaceutical industry is increasingly focused on taking actions to ensure the continuity of supply of their products to patients during this transition, and to ensure their companies’ long-term access to markets and providing products to patients throughout Europe. This has been made all the made difficult by Covid-19 and its devastating impacts.

What we know so far is that, from 1st January 2021, the following will occur:

  • Marketing Authorisation (MA) holders, if held in UK, will have to be transferred to an EU or EEA country.
  • Each consignment of UK-manufactured Active Pharmaceutical Ingredients (APIs) to the EU/EEA needs to be accompanied by an MHRA certificate of conformation to EU GMPs.
  • Each batch of UK-manufactured drug product intended for the EU/EEA market will need to be released by a QP within the EU/EEA.
  • Pharmacovigilance of drug products placed on the EU/EEA market will need to be managed from a location within the EU/EEA.
  • There will no longer be unrestricted transport of goods between the EU and the UK.
  • Expect added paperwork, transport delays, and likely customs duties.


HiTech Health can act as an extension to your internal team within Europe. We offer Qualified Person (QP) services for the batch release and supply of medicinal products that can save you time and money when compared to building this expertise internally in Europe. With existing customers in the UK, we can provide a team to enable all the EU activities including product importation, QP certification and management of supply chain through to your distributor.

For the importation of medicinal products from the Great Britain (GB) to the EU, HiTech Health can act as the Importer of Record (IoR) for your company. Movement of goods from GB to the EU will be classified as international movements. Therefore, such movements will require transit declarations and tariffs. These tariffs will depend on the provision of a product identification code and HiTech Health can fully support you with this process.

The support we provide will be tailored to your company’s needs. Please email us at info@hitech-health.com to request further information on the range of services we can provide.

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