Chris Waine

Chris Waine

Principal Toxicologist

UKRT/ERT

Chris joined bibra at the beginning of 2013 after gaining an MChem in Chemistry with Forensic Science from the University of Manchester, and has been a European Registered Toxicologist since 2018.

He leads on several of bibra’s projects relating to the REACH regulation, helping clients in several sectors meet their registration obligations and respond to evaluation decisions. Chris is also heavily involved in projects in the medicines and medical devices areas, particularly the assessment of impurities and of extractables and leachables. He is also skilled at running (Q)SAR predictions of toxicology and incorporating these results into bibra’s reports. He works closely with Leadscope on several of their working groups, and is an expert panel member of the BSI and ISO Technical Committees relating to ISO 10993 on the biological evaluation of medical devices.

Outside of the office, Chris enjoys a wide range of music, and can often be found at the piano or with one of his guitars. He is an avid sports fan and enjoys regular trips to visit family and friends around Europe.

Chris's case studies and blog posts

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.

PDE for a leachable in an intravenous pharmaceutical

Case study

ICH defines a Permitted Daily Exposure (PDE) as a pharmaceutically acceptable intake “protective of public health for all patient populations” and provides specific guidance on the derivation of PDEs for threshold toxins identified as residual solvents (Q3C guideline) and elemental impurities (Q3D guideline) in pharmaceuticals.

Δ9-THC – a low-level impurity in food

Case study

The client identified a potential contamination risk in certain of their (non-cannabinoid) food products. Low levels of (-)-trans-delta-9-tetrahydrocannabinol (Δ9-THC) – the main psychoactive component of cannabis – were analytically determined in several foodstuffs, from a specific production line.

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