Case Study: Alphazyme achieves rapid, scalable molecular enzyme production with Qualio

Alphazyme Uses Qualio to Produce Molecular Enzymes at Scale for Biotech Companies

Alphazyme, a Jupiter, Florida–based biotechnology manufacturer that produces custom enzymes for large-scale biotech companies, needed a paperless, ISO 13485–compatible quality system from day one to avoid the limitations of paper records. After evaluating roughly 15 solutions, Alphazyme selected Qualio’s eQMS (1.5 years, 30+ users) to serve as a single source of truth for experiment data and external collaboration.

Qualio was implemented as Alphazyme’s foundational quality system—handling lab notebooks, document control, reviews and approvals—which enabled rapid product development (bringing multiple enzyme projects online in months), streamlined remote collaboration with easy PDF exports for clients, improved team productivity as headcount grew, and helped prepare the company for ISO 13485:2016 certification; clients and auditors praised the approach. Overall, Qualio accelerated Alphazyme’s development timelines, increased transparency, and future-proofed their quality processes.

Alphazyme

Christopher Benoit

Chief Executive Officer