Open Orphan PLC CAP accreditation
September 01 2022 - 2:20AM
RNS Non-Regulatory
TIDMORPH
Open Orphan PLC
01 September 2022
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 s upport 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."
For further information please contact:
Open Orphan plc +44 (0) 20 7756 1300
Yamin Khan, Chief Executive Officer
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Stephanie Cuthbert / Phillip Marriage +44 (0) 7796 794 663 / +44 (0) 7867
/ 984 082 /
Louis Ashe-Jepson +44 (0) 7747 515 393
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(R) platform, this unique dataset includes clinical,
immunological, virological, and digital (wearable) biomarkers.
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