Charles Johnson

Charlie Johnson

Senior Toxicologist

UKRT/ERT

Charlie joined the bibra team in mid-2015 after he completed his MChem degree, which included a six-month organic chemistry project in Queensland, Australia. He is now a senior toxicologist and manages a range of projects, notably for clients within the medical device, pharmaceutical and e-cigarette industries. He has a wealth of experience in the medical device sector. He has conducted biological evaluations for a variety of interesting devices with numerous medical applications, and routinely provides scientific advice to clients with a consideration of biocompatibility testing strategy. He actively keeps up to date with scientific and regulatory advances in the industry, notably with respect to the development of ISO 10993 standards.

Charlie has also been involved in projects assessing safety of e-cigarettes and e-liquids, often in the context of the EU Tobacco Products Directive (TPD) and US FDA Premarket Tobacco Product Application (PMTA) frameworks. He has also co-authored a poster (along with Richard Young) on "Application of the Human Health Risk Assessment Process for Evaluation Electronic Cigarettes" - click here to download.

Charlie’s interest in science is not limited to toxicology, but also extends to the world of beer and brewing. After moving out of London and into rural Kent, he is now an active homebrewer, and is always keen to discuss the amber nectar (with anybody that will listen)!

Charlie's case studies and blog posts

FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS

Blog articles

As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).

ISO 18562 evaluation of a medical device in contact with the breathing gas pathway

Case study

As part of a large programme of work in evaluating the safety of a new endotracheal tube device, bibra was asked to evaluate the health risks posed by exposure to potentially hazardous substances that may be transferred to the patient via the gas stream during device use.

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.

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

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