Introducing our GMP manufacturing facility
We are proud to announce the launch of our new GMP manufacturing facility, expanding our capabilities to support the growing demands of the biotechnology and pharmaceutical industries.
Designed to meet stringent quality standards, the facility enables reliable, scalable production of high-quality enzymes for regulated workflows, empowering our partners to move from development to commercial supply with confidence.
Facility design optimized for quality and scale
Alphazyme’s GMP enzyme manufacturing facility spans 5,000 square feet and is designed to support high-quality, end-to-end enzyme production. The space includes four dedicated production suites, with two operating at Grade D / ISO 8 standards, enabling controlled and compliant processing environments. The facility is fully equipped for upstream operations, buffer preparation, downstream processing, and final formulation with fill-finish capabilities. In addition, it features a dedicated GMP warehouse, as well as essential support areas such as QC laboratories, ensuring efficient workflow, material handling, and regulatory compliance for GMP customers. All operations are supported by an ISO 13485 certified quality management system, ensuring consistent quality and traceability for regulated applications.
Commitment to quality and operational excellence
Our manufacturing and quality systems are designed to ensure consistent product safety, purity, and performance at every stage of production. Guided by internationally recognized quality standards and supported by robust facility controls, testing programs, and quality oversight, we implement comprehensive measures from raw material qualification through final product release. The following capabilities highlight the key elements of our quality framework.
Our GMP enzyme portfolio
GMP enzymes are produced under stringent quality systems to ensure high purity, consistency, and full traceability for regulated applications. They undergo rigorous testing and controlled manufacturing to minimize risk and meet regulatory expectations. The list of GMP enzymes:
- CleanScribe ™ RNA Polymerase (GE107)
- WT T7 RNA Polymerase (GE053)
- E. coli Inorganic Pyrophosphatase (GE051)
- Engineered RNase Inhibitor (GE075)
- DNase I (GE139)
- BspQI (GE097)
- 2'-O-Methyltransferase (GE019)
- Vaccinia Capping Enzyme (VCE) (GE023)
- T4 RNA Ligase I (GE129)
What sets Alphazyme apart
Alphazyme boasts a best in class team renowned for its ability to think outside the box and redefine the production of molecular biology enzymes. Our focus is on:
Built for scale
Alphazyme excels in meeting increased supply demands without the need for extensive expansion or hiring. Our expertise ensures reduced lot-to-lot variability by leveraging larger batches for production.
Quality assurance
With an ISO 13485:2016 Quality Management System at our core and eQMS backbone, Alphazyme supports Amplification, NGS, and mRNA technologies. Our locked process design minimizes variability, offering customizable specifications to meet regulatory requirements and support partners’ commercialization pathways.
Competitive pricing
Alphazyme offers targeted pricing solutions, empowering customers to enhance profitability and success in their markets
Rapid turnaround
We prioritize efficiency with short turnaround, ensuring swift delivery and responsiveness to customer needs.
