Toxikon Europe - Preclinical Safety Studies and QC Testing for the Life Science Community

For more than 30 years Toxikon has been a leading contract research organisation (CRO) providing high-quality preclinical safety studies to the life science community.

Toxikon operates state-of-the-art facilities in the US as well as Europe, both locations being FDA registered and ISO 17025 accredited. As a CRO the company offers services in worldwide GMP-GLP compliance testing for the medical, pharmaceutical and biotech industries.

Extractables and leachables studies

Toxikon Europe has vast expertise in extractables and leachables (E&L) testing, and in this field of expertise its laboratory is running the GMP programmes that are necessary to meet FDA, EMEA and PQRI requirements.

The E&L protocols developed by Toxikon are well accepted by all market-leading container / closure manufacturers and pharma companies. Customised protocols can be developed for specific applications, including disposables, injectables and parenterals, inhalables and ophthalmics.

Container / closure testing and physico-chemical, in-vitro and in-vivo biocompatibility testing

Toxikon Europe cooperates with leading container / closure manufacturers and pharmaceutical companies to help these industries comply with the new requirements of container / closure testing.

In addition to a comprehensive analytical approach, based on a broad array of analytical techniques to study container / content interactions, Toxikon Europe also provides services in physico-chemical, in-vitro and in-vivo biocompatibility testing, according to European, US and Japanese pharmacopoeias.

Extractables screener database - TOX-RAY™

Toxikon developed an extractables screener database that allows identifying over 1600 compounds in a unique way. Reducing the number of "unknown compounds" is one of the most important benefits of this exceptional tool.

Toxicological risk assessment for extractables and leachables studies

In addition, Toxikon can assist in the assessment of the scientific data obtained in both extractables and leachables studies, via a toxicological risk assessment. These toxicological studies try to assess if the E&L concentration levels present in the active substance / medicinal product can be considered as "toxicologically safe".

The extractables and leachables -protocols, developed by Toxikon, are well accepted by all market leading container / closure manufacturers and pharma companies. Customised protocols can be developed for specific applications: disposables, injectables and parenterals, inhalables, ophthalmics.

QP-batch controls, rapid microbiology development and preclinical testing capabilities

The company is knowledgeable in all regulatory pathways and strategies, many of which are negotiated based on scientific data with the regulatory agencies. Toxikon participates in defending product submissions and negotiating strategies for its clients. Its services will continue to change as regulatory testing requirements dictate these changes, and as testing technology and instrumentation improve.

Toxikon Europe is currently expanding its services into the pharmaceutical and biotech industry sectors related to stability testing and batch controls as well as the development of rapid microbiology techniques. Toxikon's Qualified Person guarantees a compliant release of Certificates of Analysis using validated Sponsor Specific Protocols, according to current cGMP requirements.

Toxikon Europe nv
Romeinsestraat 12
B-3001 Leuven
Belgium

Jos Bollen – director, Europe
Dr Piet Christiaens – scientific director
Tel: +32 16 400484
Fax: +32 16 401304
info@toxikon.be
www.toxikon.be