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Quality is our foundation

Quality: Alphazyme's foundation

Alphazyme was founded on the belief that “Quality” is far more than a set of   specifications, a management system, or a department to assure compliance. Quality is the foundation of our business and a mindset that touches every aspect of our organization, team, and decision-making process.

Alphazyme is a manufacturer of molecular biology enzymes, featuring a growing portfolio of enzymes used in the fields of molecular diagnostics and nucleic acid therapies. Our business is entirely focused on partnerships within the genomics industry, serving start-ups to Fortune 100 companies. Through PCR tests and mRNA vaccines, the global pandemic ushered “genetic literacy” to the forefront of medicine. A strong Quality Management System is central to Alphazyme’s ability to support these technologies, and Alphazyme selected the ISO 13485:2016 standard as the foundation of our Quality Management System based on its relevance to our molecular diagnostic industry partners and the Standard’s alignment, as a QMS, with the FDA’s ICH Q10 guidelines for pharmaceutical manufacturing.

Some key features of the Alphazyme Quality System include:

  • Full product lifecycle traceability within our eQMS:
    • Comprehensive design history files
    • Full equipment traceability
    • Stage-appropriate labeling/product Certificates of Analysis
    • Formal review, approval process on all experimental/production documentation
    • Comprehensive batch records for each product lot
  • Purpose-build enzyme production facility:
    • Vertical integration of all enzyme development, production, and testing operations
    • BSE/TSE compliant environment (all processes, all the time)
    • Access-controlled laboratory suites separated by function
    • Environmental controls (single-pass HEPA filtration, pressure/temperature/humidity monitoring)
  • Production Process Controls:
    • Complete training history files for all staff
    • Process development tracked in electronic lab notebooks, with reviews/approvals
    • Formal production batch records, with product grade-appropriate oversight
    • Full set of QC tests to support life science, diagnostic, and pharmaceutical product use-cases
  • Audit-readiness:
    • eQMS system supports rapid retrieval/sharing of critical documents
    • Auditors granted limited QMS access to facilitate “remote” auditing
    • ISO 13485:2016 certification ensures harmonization with ICH Q10 QMS expectations

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