Enrico Allegra

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As a Clinical Microbiologist, Enrico has been working in the regulatory world of pre-clinical safety assessment for over a decade. He graduated with a Bachelor of Science degree in Immunology with medical Microbiology followed by a master’s degree in clinical microbiology Queen Mary University of London in 2013.

As part of his MSc’s project, he collaborated with the Barts Health NHS Trust to develop a diagnostic PCR cycle to detect Pneumocystis jirovecii in samples from immunocompromised patients. This helped reduce the turnaround time from several days to less than 12 hours.
During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients. Over the last few years, he has been actively involved the scientific community publishing various peer-reviewed papers for the introduction of novelty assays of safety assessments. He positively contributed pioneering new alternative to in vivo testing for cytotoxicity using insect models alongside cell culture testing. He is a certified biosafety officer acting as the Technical Lead at Test Labs for any UKAS ISO 17025 testing.

During his career he has worked as a Study Director conducting pre-clinical testing under GLP requirements working for a large CRO company. In this role he was able to gain expert knowledge for product testing to meet the requirements for regulatory submission to various authorising bodies, such as FDA, EPA, MHRA. He was heavily involved in method transfer and development, with a keen interest in bringing innovative testing procedures to meet client needs. As a result, Enrico used all his previous knowledge and expertise to help setting up the new Medical Device testing facility for Test Labs.

As part of his new role Enrico has helped the company achieving various new accreditations for Medical Device testing including the reprocessing validation for Class Ir Medical Devices under the scope of ISO 17025. Guiding the analytical team for reprocessing testing he has gained invaluable knowledge in customising testing regimes to accommodate reprocessing of reusable Medical Devices with emphasis on process optimisation and safety aspect.

Here at Test Labs, he acts as the Head of Laboratory overseeing the operation of Medical Device testing spanning from microbiology, chemistry and product testing. Guided by a deep understanding of product development and regulatory standards, he strives for excellence in both clinical evaluations and technical assessments.

Articles by Enrico Allegra