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

In silico prediction of genotoxicity and carcinogenicity

Case study

As part of their overall regulatory requirements, the client was asked to provide an assessment of the known or predicted genotoxicity and carcinogenicity of a number of ingredients in their products. Bibra were provided with a list of several substances and asked to carry out this work following the genetic toxicology in silico (GIST) protocol.

Updating REACH dossiers following ECHA Evaluation decisions

Case study

Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to the European Chemicals Agency (ECHA). The Agency can, after evaluating the information provided by the registrant, require the company to update or amend their dossier, including with the addition of new experimental data. This is called a “Compliance Check decision”

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.

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