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CMO & CDMO

ISO 13485-certified manufacturing with integrated CMO/CDMO development capabilities and scalable technology transfer services. Reliable execution from development to large-scale production.

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CMO/CDMO Development

We offer both CMO and CDMO services. As a CMO, we provide contract manufacturing under defined specifications. As a CDMO, we additionally support limited development activities, including assay adaptation, optimization, and format adjustments, such as refining existing lateral flow immunoassays to meet specific technical or market requirements, without engaging in full-scale new product development.

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ISO 13485 manufacturing

Manufacturing is performed under an ISO 13485-certified quality management system, ensuring compliance with international medical device standards. All processes are controlled through defined procedures, documentation, and quality checks, supporting consistent production and traceability across all stages of manufacturing.

ISO

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Scalable tech transfer

We support the transition from technical concept or transferred process into stable, scalable manufacturing. This includes aligning materials, process parameters, and quality controls to ensure reproducibility and efficiency as production volumes increase.

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Shenzhen Kang Sheng Bao
Biotechnology Co., Ltd.

Second Floor, Block 3, Anda

Electronic Industrial Park,

Fuhai, Bao’an District,

518103 Shenzhen, 

Guangdong Province, PRC

 

+86 0755 27417763 

 

info@ksbbiotech.com