Quality is our 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