Jessica Gagalang

Jessica Gagalang

Toxicologist

Jessica joined bibra in 2021 after completing her master’s degree in Analytical Toxicology from King’s College London. She also holds a BSc in Natural Sciences from UCL, specialising in organic chemistry and biomedical sciences.

Since joining, Jessica has been involved in various projects, including the production of screening assessments of extractables and leachables, evaluating and summarising biocompatibility studies on medical devices in compliance with ISO 10993 guidance and preparing hazard assessments on cosmetic ingredients.

Additionally, Jessica regularly scans Expert Group websites and writes brief summaries on newly released toxicity reports for Toxicology and Regulatory News, bibra’s monthly publication.

Outside of work Jessica loves cooking and trying out new food, and then burning it all off training in Wing Chun and Brazilian Jiu Jitsu.

Jessica's primary areas of focus

Risk Assessment

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Hazard Characterisation

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Literature Searching

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Extractables + Leachables

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Jessica's case studies and blog posts

Biocompatibility evaluation of a series of autoinjector medical devices

Case study

The company manufactures a range of parts for use as components in a variety of medical devices.

Toxicological risk assessment of leachables from a combination product

Case study

The client was developing a ready-to-use (RTU) process for the administration of a viral-based product in a clinical setting. Bibra was requested to assist with the assessment of extractables during the development phase and leachables in the final RTU process - viral vector product.

Literature review and in silico prediction of metabolites

Case study

As part of their overall regulatory requirements, the client was asked to provide information on the known or predicted metabolites of a number of ingredients in their products. This formed part of a broader programme of work that bibra conducted for this client.

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