Toxikon Europe - Preclinical Safety Studies and GMP-GLP Compliance Testing

Toxikon is a leading contract research organisation (CRO) that provides comprehensive analytical services for all stages of product development, from concept to final product release. The scientific approach of our experienced staff provides comprehensive techniques for the pharmaceutical and biotechnology industries, including method development and validation, stability studies, extractables and leachables and bio-analytical services.

Our facilities and experienced laboratory management can offer the highest quality of work in compliance with GMP, GLP OECD and ISO 17025. With decades of experience, our team will collaborate with you as an extension of your company to facilitate drug and device development, achieve product safety, regulatory compliance, as well as maintain the highest levels of laboratory quality control.

Toxikon can offer you services that will facilitate product development by reducing the potential for product and process failure. By partnering with us and learning your application, Toxikon provides specific solutions and results that will facilitate development.

Extractables and leachables testing

Toxikon Europe has a wealth of experience in extractables and leachables (E&L) testing. Its laboratory runs the GMP programmes that are necessary to meet FDA, EMA and PQRI requirements.

The extractables and leachables protocols developed by Toxikon are 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.

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.

Biocompatibility testing

Toxikon Europe provides services in physico-chemical, in-vitro and in-vivo biocompatibility testing, according to European, US and Japanese pharmacopoeias.

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

Toxicological assessments for extractables and leachables studies

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

Analytical and bio-analytical services and EU batch release testing

Toxikon Europe is recognised for the analysis and control of pharmaceutical products by the Belgian Ministry of Health. This recognition means EU-GMP compliance. The Toxikon Europe laboratory is inspected and recognised by the Belgian Federal Agency for Medicinal and Healthcare Products (FAMHP), GLP certified by the Scientific Institute of Public Health (IPH) (identification number: T02), FDA registered (FDA Establishment Identifier (FEI): 3005742674) and ISO 17025 accredited by BELAC (identification number: 363-TEST). All testing is carried out according to European GMP Guidelines and a certificate of analysis is released by a Qualified Person.

Analytical services include, but are not limited to, EU lot release testing, API, ICH stability storage and testing, routine formulation analysis, method development / transfer / validation, raw and finished product testing, physicochemical studies (EP, USP and JP), accelerated aging, forced degradation, photostability, identification and synthetisation of degradation products, particle size distribution / analysis, dissolution testing and water content.

Bio-analytical services include, but are not limited to, method development / transfer / validation, dose formulation analysis, preclinical and clinical sample analysis, toxicokinetics / pharmacokinetics, LC / MC /MS, immmunoassays and metabolite isolation / identification

Complementary services include, but are not limited to, compendial testing, physicochemical, residue on ignition, non-volatile residue, heavy metals analysis, residual solvent testing, total organic carbon, total inorganic carbon, impurity identification and impurity synthesis.

Traditional microbiology services

As part of its range of traditional microbiology services, Toxikon offers comprehensive programmes including routine lot release and specialised microbiology assays for efficacy evaluations:

• Bioburden
• Sterility testing
• Bacterial endotoxin (LAL)
• Biological indicator testing
• Microbial barrier challenge
• Preservative effectiveness
• Antimicrobial assays
• Reusable device validations (cleaning, disinfection, sterilisation)

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. Sterility testing could be reduced to obtain results within the same day.