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, EMA 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 has developed an extractables screener database that allows the identification of over 2,000 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’.
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.
Rapid microbiology services
From significantly reduced time to result to improved sensitivity and specificity, shorter product release times, and improved process control, life science industries stand to gain more from rapid microbiology methods than just these key benefits. While these will undoubtedly yield considerable cost savings for sterility tests, rapid microbiology services from Toxikon can also play a significant role in bioburden assessment, environmental monitoring, as well as raw material, in-process, control, and microbial limit testing.
Toxikon uses the state-of-the-art AES Chemunex Scan RDI™ as well as GMP grade A isolator technology. This automated rapid microbiology platform directly distinguishes individual cells without requiring a time-consuming growth stage.
Combination drug products
A new and rapidly developing area is the combination of drug devices. This category includes the use of polymers or drugs for enhancing the performance of medical devices and the use of devices to improve drug efficacy and safety. This bio-convergence requires expertise in both medical device and pharmaceutical testing.
Services in this category include:
- Analytical chemistry
- Extractables and leachables testing
- Material compatibility
- Novel study protocols
Biopharmaceuticals as novel therapeutics for human disease
Biopharmaceuticals are becoming increasingly important as novel therapeutics for human disease. Many of these products are proteins or biopolymers in which there is no extensive toxicology or pharmacology information or experience as biotherapeutics. Added to these are more usual treatments using cell-base or stem cell therapies.
Specialised testing using molecular biology and immunoassay techniques is available as well as animal models to evaluate immunogenicity and immunotoxicology.
Toxicology / pharmacology services
Toxikon specialises in performing drug safety studies in rodents and non-rodents with various administration routes available such as oral, intravenous, ocular, subcutaneous and intraperitoneal.
Our services include:
- Repeat dose toxicity
- ADME studies
- Molecular testing
Support services include: histology, pathology, clinical chemistry, and hematology.
Non-clinical data generation for pharmaceuticals
Appropriate non-clinical data generation enhances the probability of a favourable outcome in the clinical phases of development. The following services are offered in this market:
Products and Services
Piet Christiaens, Ph.D., scientific director for Toxikon Europe (Leuven, Belgium), will present 'Extractable and Leachable Studies: How to Step Up the Right Testing Strategy', at the 4th Pre-Fill Syringe ConferenceRead more
Toxikon Europe, a preclinical contract research organisation specialised in extractables and leachables testing for the pharmaceutical and biopharmaceutical industries, is ramping up its research and development by investing approximately $500,000 annually over the next five years to further increase its extractables and leachables expertise and capabilitiesRead more