IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech Health is delighted to be featured as part of Ireland’s exciting growth in the cell and gene therapy space. Hitech was the first commercial company to have a licence to manufacture these advanced medicines in Ireland. It works with some large global companies, but Managing Director Brian Harrison says most of the companies in the cell and gene therapy space are smaller companies including university spin outs.
In many cases, these advanced medicine companies have products in development, and need expertise to manufacture pre-clinical materials as is required for toxicology studies. Hitech Health can also manufacture clinical trial materials for these advanced medicine companies once the potential treatment has been approved by regulators to be used in patients . In some cases, large pharma companies outsource these advanced medicine products to contractors and they continue to use Hitech for support.
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 disruption to the intricate supply chains of cell and gene therapies and ultimately patients. HiTech Health explores 5 key considerations for a cross-functional team to examine when partaking in the CDMO selection process.
Does your CDMO have an experienced CGT team?
The complex and time-sensitive nature of CGT manufacturing processes makes it imperative to select a CDMO with a team who have deep knowledge of cell and gene therapies. The technical and regulatory landscapes in the CGT industry are changing frequently and ensuring your CDMO has in-depth expertise and flexibility is crucial to success. Assessing the CGT experience of the proposed CDMO team could reduce the risk of knowledge gaps later. A CDMO may have a strong track record of developing and manufacturing small molecule products and biologics but may have limited experience of CGTs. Are sufficient resources in place now and into the future?
Is there an integrated project management approach defined by the CDMO?
If you have shortlisted potential CDMO partners, have you enquired about their project management approach? How do the proposed approaches differ among the potential partners? Having an integrated project management approach that ensures seamless alignment between production, supply chain, QC testing personnel and many other functions is paramount given the stringent timeframe for supplying CGTs to patients. Understanding how frequently you will meet with the assigned CDMO project manager and how they will communicate with you should be clearly defined from the beginning.
Does the CDMO practice effective Quality by Design (QbD)?
Considering if a CDMO practices Quality by Design (QbD) is an important part of the due diligence process. The CDMO team may work closely with you to measure, analyse and report on the quality attributes of the CGT product. The team members who develop your upstream regulatory strategy and initial CMC plan need to be able to work closely with a trusted CDMO partner who can ensure quality and compliance goals are met. Have you considered an on-site audit of the CDMO before the final selection?
How flexible is the potential CDMO partner?
During the due diligence assessment, look at the CDMO’s internal systems and workflows for a true indication of their fit as a potential partner. The CDMO should be experienced and agile to help you navigate unforeseen challenges, open and transparent to help you mitigate risks and control your costs as well as being fully committed to the ultimate goal of providing CGTs to the patients who vitally need them. These are the characteristics of a resilient and long-lasting partnership, and the indicators of future success.
From the start of a project, the right CDMO will encourage an ongoing dialogue about the quality, pace and cost considerations of your project. They will focus on developing a robust and scalable approach that will work for the entire lifecycle of your project.
Is there a Business Continuity Plan (BCP) that has been implemented and managed effectively by the CDMO?
The CDMO’s ability to maintain essential functions during and after an unforeseen event has occurred is very important and should be assessed prior to signing a contract. Business continuity planning, in this case, relates to establishing risk management processes and procedures that aim to prevent interruptions to manufacturing and supplying CGTs. If an unforeseen event occurs, such as critical components not being available, how will the CDMO mitigate or manage the issues to ensure the effects on operations are minimised. Have you requested a copy of your shortlisted CDMO’s business continuity plan?
Learn more about our cell and gene therapy services by clicking here
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.
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.
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
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...
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.
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
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...
