Manufacturing & quality · Zhuhai, China

Reagent manufacturing & quality,documented lot by lot.

Expression, purification, formulation, filling and packaging run as one workflow under standardized SOPs and batch records. Every lot is released against predefined specifications and ships with a lot-specific CoA and SDS.

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Certificates

Certificates and selected GMP-grade product lines.

ISO 13485 certified by SGS and ISO 9001 certified by CQC. Download the certificates for your supplier file.

ISO 13485:2016

Certified by SGS · valid until 13 November 2027

Scope, as printed: “Design, development, production of proteins for in vitro diagnostic medical device”

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ISO 9001:2015

Certified by CQC · valid until 19 June 2027

Scope, as printed: “Research and development, Production of Molecular Diagnostics Enzymes (Amplification enzyme) and Amplification Reagents”

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GMP-grade for selected product lines

GMP-grade manufacturing for selected product lines, including GMP-grade IVT enzymes and nucleotide solutions for mRNA manufacturing.

mRNA raw materials

Manufacturing

One workflow, from expression to release.

Headquarters, R&D and manufacturing are in Zhuhai, Guangdong, China. Recombinant expression and fermentation are done in-house.

01Expression & fermentation
02Purification
03Formulation
04Filling & packaging
05Lot release

In-process controls at critical manufacturing steps.
Lot-to-lot consistency controls, including critical process parameters and release testing.
Flexible batch sizes from pilot runs to routine supply.

Fermentation suite with stainless-steel bioreactors in a BIORI cleanroom.

Lyophilized formatsLyophilized reagents are made in a Class 100,000 (ISO 8) cleanroom, with dispensing and capping below 10% RH. No minimum order quantity. Lyophilization service

Quality control

Quality checks built into every lot.

SOP-controlled operations, with deviation/CAPA and change control as daily practice.

SOPs & batch records

Standardized SOPs, with batch records for each production lot.

Change control

Deviation, CAPA and change control procedures support process consistency.

Lot release

Released against predefined specifications and acceptance criteria.

Traceability

Documentation and lot traceability across materials, manufacturing and QC.

Documents

Documents for your supplier file.

Certificates and product documents are online. Lot-specific documents come with quotes and orders.

Quality certificates

ISO 13485 and ISO 9001 certificates as PDF files.

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Manuals, CoA & SDS

Instruction manual, certificate of analysis and safety data sheet for every catalog number.

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Lot documents & audits

Lot-specific CoA and SDS with every lot. Key QC records and support for your customers’ audits on request.

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FAQ

Frequently asked questions.

Which manufacturing stages can BIORI support?

BIORI runs expression, purification, formulation, and filling or packaging as one integrated workflow, with flexible batch sizes from pilot runs to routine supply.

How does BIORI support lot-to-lot consistency?

BIORI uses standardized SOPs, batch records, in-process checks at critical steps, defined process parameters, release testing and change-control procedures.

What quality and traceability documentation is available?

Every lot ships with a lot-specific CoA and SDS. Key QC records and documentation for audits by your customers are available on request.

Can BIORI support scale-up and longer-term supply programs?

Yes. Defined scale-up strategies and lot-to-lot consistency controls carry a product from early evaluation to volume production. Batch sizes are flexible from pilot runs to routine supply. For OEM programs, long-term supply planning includes forecast alignment and capacity reservation options.

Next step

Need a document or have a quality question?

Tell us the catalog number and lot number, or request a quote for samples, pilot lots or routine supply.

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