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Animal Product-Free Bulk Enzymes
Products EPICENTRE has a long history of manufacturing enzymes for use as raw materials for pharmaceutical companies. Some of these companies use EPICENTRE's products in their development of injectable drugs and vaccines. We are among the elite few whose enzymes can be made without use of animal products, a.k.a. animal product-free (APF). EPICENTRE's APF products avoid animal products to ensure Bird Flu (H5N1) and Transmissible Spongiform Encephalopathies, such as scrapie, BSE, and variant Creutzfeldt-Jakob Disease (vCJD), are not present in our raw materials or processes. These processes are validated and controlled to ensure quality manufacture. Synonyms for animal product-free include animal product-safe, animal-free enzyme and animal-free product. A current list of non-catalog enzymes and enzyme formulations that EPICENTRE has produced animal product-free include:
These enzymes are typically used for DNA and RNA vaccines, transcription reactions or bacterial cell lysis for protein or nucleic acid extraction. Contact For further inquiries please email us at custom_orders@EpiBio.com Reliability EPICENTRE is a reliable supplier of biotechnology products. We work with customers to ensure timely delivery of custom or bulk products. Quality Control and Quality Assurance Products are rigidly tested by EPICENTRE's experienced Quality Control Department using robust protocols to determine product efficacy. Our Quality Control keeps retention samples, performs shelf life and stability studies, and validates assays. Quality Assurance maintains EPICENTRE's Quality System, performs internal and external audits, reviews protocol changes and ensures processes are reproducible and reliable. EPICENTRE has the expertise to test for nuclease, protease, bioburden, endotoxin, and adventitious agent contaminants to ensure the quality of our bulk pharmaceutical raw materials. Regulatory Compliance EPICENTRE complies with local, state and federal regulations where they apply to its operations. EPICENTRE's manufacturing personnel are trained in Quality System and cGMP requirements. A comprehensive safety program is in place with training for all employees. Facilities and Equipment EPICENTRE has been in business in Madison, Wisconsin since 1987, and is now located at 726 Post Road in a new state-of-the-art biotechnology facility. EPICENTRE has significant capacity for scale-up to handle almost any customer demand. Environmentally controlled work areas are available for bulk pharmaceutical raw material manufacturing. Environmentally controlled work areas include fermentation, protein purification suites, filling areas and clean benches. Our bacterial fermentation facility includes a 100 liter fermentation system. The protein purification work suites and non-environmentally controlled support areas are segregated and secured to protect product and materials. Utilities such as compressed air, water, utility and clean steam and HVAC air are designed to protect product integrity. EPICENTRE production uses USP Purified water and USP Water for Injection (WFI) for manufacturing. Training EPICENTRE manufacturing personnel are extensively trained in the techniques necessary to make biotechnology products. In addition, they are trained in documentation, regulatory compliance and equipment and process validation. Training is documented and is a part of EPICENTRE's Quality System. |
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EPICENTRE® Biotechnologies—Enzyme Systems for RNA
and DNA Research |
EPICENTRE
Biotechnologies manufactures enzymes as raw materials for pharmaceutical
and diagnostic companies. We will work with customers on their custom
manufacturing needs for our existing products and consider new product proposals
based on their value to the broader bioprocessing market. EPICENTRE's Quality
System guarantees process consistency and product reliability. If you have
a need for custom manufacturing, please contact us at