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16Nov20

Batch Testing and Release: Life after Brexit

We at KYMOS and ASPHALION are long-time partners in providing analytical and regulatory services to international pharma and biotech sectors. Our testimony goes beyond the conventional “CRO trading with UK clients” to overcome internalization barriers. Our respective services are part of a complex international supply chain that makes the effects of Brexit more visible and quantifiable. Quality Control (QC) is one of the most interdisciplinary departments at KYMOS with high demand from international clients, particularly for EU Batch Testing and Release for drug products and IMPs. The intrinsic characteristics of these services make them a great non-tariff indicator of the current mood of the market.

Brexit embarked on some important changes to the approval of drug products in the UK, where immediately following 31 January (Brexit day), they went into a transition period with the EU to give both sides breathing room to agree on the new arrangements. This transition period will last until 31 December 2020, when the new EU-UK relationship will begin as the deadline for extending the transition has now passed. Starting on 1st January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator and act as the sole barrier to apply in clinical trials, import and export, licensing and other activities.

When working with batch releases, it is crucial to have a well-established transfer of methods as delays can compromise the stock of pharmaceutical products around the world. Lluís Racionero, Director of QC, worked in the Dev/Val department at KYMOS before leading up the QC department, so his expertise spans every step of the process, from developing methods to validation, transfer and sample analysis. The demand for Batch Testing and Release (T&R) services has experienced a 5-fold increase during the last couple of years, possibly due to a lack of trust in the UK Government mitigating measures post-Brexit. 

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Moreover, most of KYMOS’ UK Batch T&R clients manufacture their Drug Products (DPs) outside of the UK, therefore, they may seek to ensure project continuity and to minimize risks through CROs and Quality Persons (QPs) based in continental Europe. In addition, KYMOS has not actively promoted their Batch T&R services indicating that the rise in demand is inbound and unprompted and likely attributed to the new regulatory requirements between the UK and EU post-Brexit.

KYMOS is a GMP and GLP-certified CRO inspected regularly by EMA and FDA. Clients working with KYMOS can have peace of mind they have a partner for every step of the process in a range of product forms from powders to injectable solutions analyses using a broad range of techniques. The high-quality standards of KYMOS are applied to every project with continuous improvement in data integration and compilation. Our clients know that they can trust not only the quality of our work but in our flexibility. When an urgent matter comes up, we do our best to adapt to our client's needs.  

Our partners at ASPHALION help out through their extensive experience in regulatory consultancy. They believe that Brexit will cause UK manufacturing, QPs and batch release activities to move into continental Europe to ensure EU approval after the transition period. This year, ASPHALION has supported several pharmaceutical companies to adapt their infrastructure/procedures according to the new expected legislations, defined by MHRA guidelines published on September the 1st, 2020 on how to act from the 1st of January, 2021 for the marketing of medicinal products in the United Kingdom. Some uncertainty still exists within these guidelines, nevertheless, during the transition period, ASPHALION recommends strongly following MHRA recommendations and employing the opinion of regulatory affairs consultants in both the UK and the EU. As a result, ASPHALION opened a new office in the city centre of London in 2020 to provide services to customers with ongoing or planned operations in the United Kingdom, one of Europe’s most important markets. The London office is the most recent addition to a growing list of established ASPHALION locations that now include Spain, Germany and the Netherlands.

If the assumptions regarding current trends outside the UK are correct, the increase in batch testing and release activities should persist during the 2020 transition, and beyond. Firms that went through the hassle of shifting to a continental CRO, including method transfer and validation as well as provider selection, may demand significant guarantees to shift back. The tandem KYMOS-ASPHALION can provide clients with robust regulatory consultancy services and the highest quality Batch Testing and Release services. 

KYMOS is a GLP/GMP-certified, GCP-compliant, EMA and FDA-inspected European contract laboratory organization specializing in CMC of small molecules and biologics.  Here you can view more information about KYMOS’ Batch Testing & Batch Release; Quality Control and Method Development, Validation and Transfer or contact us on info@kymos.com.

ASPHALION can support with in Regulatory aspects affecting Brexit offering services as acting as your UK-based MAH and UK-local contact with MHRA. ASPHALION also offers services such as Re-establish your SME status; UK PIP and YK Orphan designation,  Responsible Person for Import (RP-I),  Pharmacovigilance: Act as your UK-QPPV and  eSubmission: Publishing & submission thought UK portal, baselines for grandfathered centralized products. For more information contact info@asphalion.com.
 

 

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