Eurofins BPT expands biopharma testing services in Canada
Douglas J. Turk, PhD, Business Unit Manager, EBPT Toronto
With the integration of Eurofins BioPharma Product Testing (EBPT) Canada to its North American group of companies, EBPT adds a key player to its product testing and release service capabilities and further expands its geographic footprint. Joining our existing EBPT testing laboratories in Lancaster, Columbia, Portage, Charlotte, Cary, Jacksonville, and San Diego, our Canadian facility (based in Toronto) offers many of the same API and finished product cGMP testing capabilities that our customers have come to expect from our premier T&C organization.
Our North American network of cGMP biopharma product testing laboratories delivers a harmonized approach to laboratory services that ensures all global customers receive the same quality of service at any of our facilities. All of our EBPT laboratories operate under a uniform Global Quality Policy manual, utilize the same CAPA/Exceptions Management system, the same Document Management and Control system, and provide our customers with one of the most innovative, comprehensive, and user-friendly data management tools in the industry through our secure online LabAccess.com portal. We offer our clients flexible service delivery models such as the traditional Fee-for-Service (FFS), Full Time Equivalent (FTE) programs with dedicated full-time employees to work on client projects at our GMP facilities, and Professional Scientific Services (PSS) with full-time scientists and technical support staff managed by PSS at clients’ facilities.
Each EBPT operation has a wide range of chemistry and microbiology expertise along with a variety of state-of-the-art instrumentation necessary to perform raw material and finished product testing. Our EBPT experts provide comprehensive materials testing against specifications for identity, potency, impurities, physical properties, and stability under strict cGMP compliance.
Our laboratories are organized by function to enable our analysts to apply their specialized techniques to individual client needs. Our Toronto Chemistry Team performs raw materials and finished product testing, using compendial methods, client specific methods, and internal house methods. We have a vast array of analytical techniques capable of performing a variety of physical characterization tests, including dissolution, disintegration, titrations, friability, hardness, as well as assays for active components, label claims, pesticides, residual solvents, and elemental and chromatographic impurities. EBPT Toronto has an extensive controlled substance and narcotics license authorized by Health Canada that facilitates the GMP analytical testing of controlled substances and psychedelics, such as psilocybin, psilocin, DMT, LSD, mescaline, cannabis, cocaine, and MDMA.
Our Microbiology Team performs comprehensive microbiology testing for both sterile and non-sterile products, using client-specific and compendial assays. The team performs microbial validations (suitability testing), microbial identification, and microbial limit testing (MLT) on a variety of organisms. The team is able to conduct a number of antibiotic assays as per USP <81> in addition to disinfectant and bioburden studies, as well as antimicrobial effectiveness and endotoxin testing (inhibition & enhancement studies). EBPT Toronto’s indispensable R&D Team assists our clients with method development, method transfer, and method validation or verification activities, which can be customized to meet our clients’ specific requirements.
Our Regulatory Consulting Team offers another distinct asset to EBPT Toronto. Our regulatory services unit can support our clients quality and compliance management needs from concept to operation in regards to Health Canada regulations for drugs, medical devices, natural health products, and cosmetics. In addition to these core testing and consultation services, EBPT Toronto offers a well-established stability program that complies with ICH (Q1) guidelines. The laboratory is equipped with temperature and humidity controlled climatic environmental chambers as well as a number of incubators, refrigerators, and freezers that can perform stability studies (temperature, humidity, light, and cycling), according to specific regulations for virtually any type of product.
Our EBPT Toronto Team is proud to be part of the largest network of harmonized biopharmaceutical cGMP testing laboratories in the world. Eurofins BioPharma Product Testing North America continues to enable our clients to advance their drug candidates from development through commercialization while ensuring regulatory compliance, cost effectiveness, on-time delivery, and always with our highest customer focus available in the industry.