Our Quality Management System Fulfills all the Requirements for IVD Assays and Kits

Our regulatory-compliant facilities accommodate a wide range of services and our laboratory is fully equipped with apparatus that is regularly maintained and calibrated in accordance with stringent quality assurance and regulatory requirements. We provide you with products or components produced under ISO 9001:2008 and ISO 13485:2003 guidelines to comply with medical device regulations. Accurate lot documentation and traceability are standard in our processes, and we work with you to define the ideal manufacturing specifications and tolerances to meet your needs.

Superior Enzyme OEM Solutions

Enzymatics' manufacturing team has decades of combined experience in enzyme design and production. The company has a proven track record of successes with business-to-business solutions for life science reagent and molecular diagnostics companies. Made to order products, standard-setting quality systems, technical expertise, and dedicated OEM customer service, enable us to provide the highest quality enzymes for your products and services.

Products Manufactured Under the Highest-Quality Standards for Molecular Diagnostic Assays

Enzymatics manufacturing facilities achieve the highest standards. Our propriety production process ensures that you receive products that exceed the quality of similar products produced by other suppliers. We have a growing and global list of satisfied partners in the fields of molecular diagnostics, life science research products and biotechnology that have already benefited from our high standards and quality as well as our lower prices. Our OEM partners' competitive advantage is enhanced by our commitment to supreme quality at paradigm shifting prices.

Superior Product Quality

Superior Quality starts with enhanced production and purification methods and finishes with unparalleled QC testing. Enzymatics has developed and applied industry-leading approaches to understanding enzyme quality that far surpass previous standards. We employ state of the art purification methods and conduct much more vigorous purification processes than are standard in the industry. We also apply highly sensitive and proprietary testing to our enzymes prior to release of materials to our customers.

Advanced QC tests include:

• Measurement of nuclease contamination using a proprietary test methodology
  • Provides significantly greater sensitivity than methods used by other providers
  • Ensures unsurpassed nuclease contamination monitoring in our products
• Specific Activity Testing: Assay every lot for functional activity and compare results to the amount of enzyme required to generate that level of activity
• SDS-Page Gels using Silver Nitrate Staining
  • 50 Times more sensitive than Coomassie
  • Currently the only OEM supplier providing Silver Nitrate Staining
  • Standard of ≥99% purity
• Nucleic Acid Contamination
  • Test every lot of protein we produce for contaminating host E.coli DNA using a TaqMan assay with probes against the 16s rRNA subunit
  • Reject lots that contain >10 copies more genomic DNA sequence than our negative controls

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