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ISO 13485 & 9001 certified
Operator at the control panel of a fermentation suite in the BIORI GMP workshop
Vials of lyophilized reagent beads under a capping station
Operator on the platform of a stainless-steel fermentation tank
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Enzyme engineering · Lyophilization · OEM manufacturing

Lyophilization-ReadyEnzymes & Master Mixes

BIORI engineers the enzyme, formulates it glycerol-free or freeze-dries the whole assay, and manufactures it under ISO 13485 for IVD, NGS, research and biopharma QC.

Enzyme engineering
Enzymes engineered in-houseProtein engineering and recombinant expression in-house. 1,000+ enzymes in the library, engineered in Zhuhai since 2012.
Lyophilization
Lyo-ready mixes and lyophilized beadsLyo-ready master mixes and 3 mm beads, with 18-month room-temperature data on tested mixes.
OEM manufacturing
OEM manufacturing under ISO 13485ISO 13485 and ISO 9001 (SGS). No MOQ on lyophilized batches, CoA with every lot.
Product lines

Reagents for diagnostics, NGS, research and biopharma.

Enzymes, master mixes, kits and QC tools, organised by the application you are building. Category links go straight to the product list.

Enzymes and master mixes across these lines are offered as standard, glycerol-free and lyo-ready formulations. Variant catalog numbers are searchable on each product page.

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Formulation

The same enzyme, in the format your assay needs.

The same validated enzyme can ship as a classic glycerol stock, a glycerol-free concentrate, a lyo-ready master mix or a finished lyophilized bead.

01

Standard glycerol stock

Conventional storage at −20 °C for research and assay development.

Research & development
02

Glycerol-free

Formulated for lyophilization and high-concentration mixes, for use in your own freeze-drying process.

For your freeze-dryer
03

Lyo-ready master mixes

Complete mixes ready to freeze-dry in your tube, plate or cartridge.

Tube · plate · cartridge
04

Lyophilized beads

3.0–3.4 mm beads at 25 µL, dispensed one per reaction, with continuous scheduling and no minimum order quantity.

Ready to ship

Storage and shipping conditions follow product-specific validation. Real-time stability data is published on tested lyophilized products.

Lyophilization service
Manufacturing & quality

ISO 13485 and ISO 9001 certified quality systems

Protein engineering, recombinant expression and process development happen in one Zhuhai facility, under ISO 13485 and ISO 9001 quality management.

ISO 9001:2015 certificate

ISO 9001:2015

Quality management system certificate

Download PDF
ISO 13485:2016 certificate issued by SGS

ISO 13485:2016

Medical device quality management system · SGS

Download PDF
GMP compliance statement

GMP Compliance Statement

GMP-grade products available for selected product lines

Request statement
ISO 13485 · ISO 9001SGS-certified quality management for reagents and IVD raw materials.
Lot traceabilityCoA and SDS with every shipment; batch records and change control on request.
GMP-grade linesSelected IVT enzymes and raw materials manufactured to GMP grade.
Audit supportQuality, manufacturing and R&D teams answer technical and audit questions directly.
Product catalogs

Download the full portfolio.

Original PDFs with specifications, formats and ordering information for every product line.

Molecular Diagnostic Raw Material Solutions brochure coverMolecular Diagnostics Brochure2026 · PDFDownload PDF
mRNA Therapeutics brochure covermRNA & IVT Brochure2026 · PDFDownload PDF
Biological products quality control brochure coverQuality Control (QC) Brochure2026 · PDFDownload PDF
NGS Library Series brochure coverNGS & Genomics Brochure2026 · PDFDownload PDF
Life Science product catalog coverLife Science Research Brochure2026 · PDFDownload PDF
BIORI Biotechnology headquarters in Zhuhai
About BIORI

An enzyme and reagent manufacturer for kit developers

Founded in 2012, Zhuhai Biori Biotechnology Co., Ltd. develops biological raw materials and reagent solutions for life science research, in vitro diagnostics and biopharmaceutical manufacturing. Protein engineering, recombinant expression, process development and application research sit under one roof, so a request for a new format can move from bench to pilot batch without leaving the building.

2012Founded in Zhuhai
1,000+Enzymes in the library
20,000+Customers served
3 locationsUSA · Hong Kong · Zhuhai
About BIORI
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