Positioned primarily to meet the needs of the pharmaceutical and biotechnology industries, the company has unique expertise in ensuring the control of biological, chemical and microbiological contamination. We met Pierre Devaux, Scientific Director, and Elodie Pastre, CEO. Interview.
Introduce us to Theraxel…
Theraxel is the meeting of a chemical engineer and a microbiologist pharmacist. We are based in Beaune in the Côte d’Or. We are very attached to our region of Burgundy-Franche-Comté, a European crossroads located between Paris, Brussels, Strasbourg, Geneva and Lyon, bordering Switzerland and Germany. Theraxel is a company with a European and international outlook, already active in Scandinavia, the United States, China and Africa. Our team is present throughout France. We have taken the gamble of hiring senior experts on permanent contracts who bring us their skills in our key areas.
What is your core business ?
Controlling the biological, chemical and microbiological contamination of health products. This consists of guaranteeing our customers the quality of each of the units produced, while ensuring that the strict regulatory context coexists with industrial and economic realities.
Four themes are particularly important to us, and they are not the only ones:
– Sterility assurance, which is subject to very strict regulations and which has just evolved via Annex 1 published by the EMA in which all the stages in the life cycle of a sterile medicinal product are well described. A strategic summary document entitled Contamination Control Strategy (CCS) must be provided and our knowledge allows us to create it.
– Expertise in cleaning and disinfection: On the one hand, the cleaning and disinfection of the general surfaces of our premises and on the other hand, the cleaning and disinfection of the surfaces of the equipment we use. In both cases, this is based on processes that must be reproducible and effective. We ensure the control of cross-contamination.
– Preparing for or responding to audits/inspections: We help our clients prepare for audits or inspections by the Health Authorities. Our experts are able to identify discrepancies and propose appropriate strategies. Our goal is to do everything possible to avoid major deviations for our clients. We are committed to this.
– Conducting investigations for cases of contamination of areas or products directly: this involves identifying the cause(s) of the contamination and providing the answers to restart the activity, to destroy or release the batch or batches potentially impacted by the issue in order to guarantee the safety of patients, which is, above all, the top priority. We are setting up a dedicated team on the subject and are making our reactivity a major issue.
How is your development progressing ?
Elodie created Theraxel in 2013 and I joined her in November 2018. There were two of us. Today, Theraxel has twenty people. Our team now has the skills to help you design the factories of tomorrow. As long as we have the trust of our customers, we evolve with them. Our customers are our ambition.
At the beginning of 2021, we created Isotec’xel, a little sister company to Theraxel, specialising in isotechnics. The challenge is to work on the design of new barrier technologies and new associated process technologies in order to facilitate the work of operators but also to make processes as safe as possible through robotics and automation.