ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

Clinical laboratories achieves CAP accreditation

Confirms hVIVO laboratories high standard of excellence

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that its clinical laboratories in Queen Mary's Bioenterprise Centre and Plumbers Row (hLab) have been awarded accreditation by the College of American Pathologists ("CAP"). The Company sought the accreditation as part of its ongoing commitment to maintaining best in class quality systems.

The CAP is the world's largest organisation of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programmes. The accreditation "supports laboratories performing testing on specimens from human, using methodologies and clinical application within the expertise of the program". This further expands on the Company's Good Clinical Practice for Laboratories (GCLP) accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA) and provides additional quality assurances of its laboratory services for its clients, especially within the United States, thus ensuring the accuracy of test results and conforming to the requirements from the US Food and Drug Administration (FDA).

hLab is a highly specialised virology and immunology laboratory, offering a suite of services to support both pre-clinical and clinical respiratory drug and vaccine discovery and development. This includes assay development, transfer and optimisation across immunology, molecular and cell-based assays, including extensive options in sample matrix and stability testing and analysis. hLab is well equipped with Biosafety Level 2 and 3 facilities to provide high quality data outputs to enable clients to achieve early proof of concept, or to make a breakthrough discovery in the pathology and possible treatment of diseases with unmet medical needs. hLAB now provides services beyond supporting the Company's in-house human challenge trials, offering lab services as a standalone service to support vaccine and drug development from pre-clinical studies through Phases I - III clinical trials.

Brandon Londt, Development Operations Director, hLab Development at hVIVO, said: "We are proud to have received the CAP accreditation, which is recognition of the quality of our laboratory and further demonstrates our commitment to maintaining the highest standards of excellence and ensuring that our work practices meet the rigorous CAP assessment standards. This accreditation will provide current and future clients a further degree of confidence in the quality of work performed in our laboratory and assurances of the results we produce."

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Notes to Editors

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.