We perform toxicity testing and toxicological screening studied in vitro on a variety of products, such as pharmaceuticals, biopharmaceuticals, medical devices, cosmetics, personal care products, disinfectants, special chemicals, and tobacco, etc. Over the past few decades, testing toxicity using non-animal methods (in vitro, ex vivo, and in silica) have become more and more popular thanks to the advancement of science, collaborative development and validation efforts, consumer pressure and regulatory acceptance.
Biopharmaceutical products have an inherent risk of transmitting infectious viruses due to variables in source materials, manufacturing processes and the route of administration employed throughout production. In order to mitigate the viral contamination risk, we work with client project teams on a multi-faceted, complementary approach, including selecting and testing the starting materials, direct testing of the product at various stages of production, and incorporating and validating viral inactivation and removal steps (i.e., “viral clearance” studies).
Biologics have an inherent risk of viral contamination. In order to mitigate the viral contamination risk, we work with clients on a tried and true approach required by regulatory authorities. We collaborate closely with client teams on selecting and testing the starting materials, direct testing of the product at various stages of production, and incorporating and validating viral clearance steps.
We offer innovative technical consulting that has assisted manufacturers in the medical device, diagnostic, pharmaceutical, and related industries. Our material specialists have a strong background in materials applications, uses and environmental effects on materials. In the medical device and diagnostic industries our expertise cover a broad range of consulting and testing services. GMP medical device manufacturers can partner with Microbac in accordance with 21 CFR 820.50 and be considered an extension of the manufacturer’s quality system.
Analytical chemistry and in vitro toxicology testing are used to test the interaction between a medical device and physiological system to assess patient safety. Our expertise in materials science, chemistry of component materials and in vitro toxicology work together to meet global compliance requirements per ISO 10993.
Understanding a product’s shelf life, or how long the item will last before its quality or safety is compromised, is critical to its success in the marketplace. Shelf life life can be difficult to determine because each product is different chemically and may be utilized under varying conditions. Shelf life testing can assist in your research and development, as well as quality assurance management for a variety of product types.
Microbac performs product shelf life testing for a number of different industries, including: Pharmaceuticals, Nutraceuticals, Cosmetics, Raw Materials, Finished Product, Development Products, Dietary Supplements. Our approach is to define a protocols specific to your application and recreate the conditions required to provide the most reliable study possible. We evaluate the risks associated with your product and determine a testing scheme to address those risks. A team of dedicated shelf life testing experts and product testing facilities provide accurate and empowering results.
Product shelf life testing design needs to be scientifically sound to support the eventual results that will be utilized in the marketplace. We utilize the full range of FDA and USDA tools, as well as additional academic and industry-proven research sources to design a shelf life tests to evaluate various product qualities. Our studies are performed in a cGMP compliant laboratory and we offer ISO 17025:2005 accredited Quality Management Services.
Our in vivo clinical trial testing includes a collaboration with our client’s for the development of the study protocol. We have a large database of volunteers and superior project management. Our clients are provided with frequent updates to track study progress through the enrollment, conduct and reporting process. Microbac’s performance, data integrity and quality assurance are the foundation of the studies performed at our laboratories.