BioEngine

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BioEngine has developed nearly 100 types of serum-free media for different cell lines, which are suitable for antibodies, vaccines and cell and gene therapy (CGT) fields.
Technical Services
Technical Services

BioEngine provides biopharmaceutical companies and organizations with high-quality one-stop services from cell culture process development and optimization, medium formulation design to medium processing and manufacturing.
OEM
OEM

Relying on its international-leading production capacity, BioEngine guarantees the stable and rapid production of medium products, which meet the requirements of major quality systems in China and abroad.
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Media Center

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About BioEngine
About BioEngine

Get to know BioEngine and "Intelligent Manufacturing in China" serum-free medium.

Introduction & Process Advantages & Cases Manufacturing Process & Capacity Quality System Management

Home OEM Quality System Management

OEM

Quality System Management

Raw Material Quality Control

Up to 80% of local raw material proportion

Ensure stable and controllable quality of incoming materials

Strictly control supplier admittance and evaluation process to select suppliers that meet the requirements of the GMP system;

Establish testing release criteria and develop key control indicators for incoming raw materials;

Batch inspection of incoming materials to check whether raw material purity, impurity limit and other indicators meet the quality requirements;

Implement online monitoring of storage conditions and store raw materials in strict accordance with requirements.

Finished product quality assurance

Ensure comprehensive performance verification of finished products and full inspection of finished products before delivery

Comprehensive testing and detection capabilities for finishing products

Physical and chemical tests: pH meter, turbidity meter, osmometer, spectrophotometer, Karl Fischer moisture meter, laser particle size analyzer, total organic carbon analyzer, etc.
Analysis and detection: HPLC, GC, microplate reader, etc.
Microbial detection: clean workbench, biological safety cabinet, PCR machines, gel imagers, microbial incubators, etc.
Cell detection: cell counter, CO₂ shaker, CO₂ incubator, bio-reactor, etc.

Lean Management & Information Management

Beijin is equipped with 5 information systems (PLM, ERP, MES, LIMS and QMS) to ensure the accuracy of material use and weighing, guarantee the authenticity, compliance and traceability of data, and help customers to meet the requirements of major quality systems.

Continuously Upgraded Multiple Quality System Certification

Obtained ISO 13485 quality management system certification from the EU medical device authority (BSI)

Lead unit of Chinese culture medium production standard and compiler of serum-free culture medium group standard, jointly published "Serum-free medium standard for human cell and tissue culture" and "Serum-free medium standard for cell culture" in December 2022

Same qualification as top foreign culture media suppliers

Comply with the requirements of relevant regulations around the world for serum-free culture media products, helping customers to achieve double reporting in the US, China and Europe.

ISO13485:2016、MDSAP (FDA)、 GMP multi-system quality standard operation

Year	Quality system	Details
2016	ISO13485:2016	The 1st culture medium company in China certified by the EU medical device authority
2021	ISO13485:2016, GMP	ISO, GMP multi-system quality standard operation
2022	ISO13485:2016, MDSAP (FDA), GMP multi-system quality standard operation	ISO, FDA, GMP multi-system quality standards in operation

Quality Management System Certification

Let us contact you

We have a professional technical team to provide high quality one-stop cell culture service from process development
and optimization, medium formulation design to medium processing and manufacturing for all biopharmaceutical companies.

If you have any question, please click "Quick Message" and leave your message, we will reply to you as soon as possible.
If anything urgent, please call (86)21-68582660-2792.

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