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.

In silico assessment of impurities in a pharmaceutical

Case study

The client presented us with the structures of a number of impurities in a medicine currently in development for advanced cancer indications.

NAMs for NGRAs

Blog articles

Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.

Want to read more case studies and blog posts that Chris has been involved in? Click below to read more.

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