IVD product development

Beacon Scientific is a lateral flow CDMO (Contract Development and Manufacturing Organization) specializing in lateral flow development and the creation of lateral flow assays (LFAs) for rapid, reliable, and cost-effective diagnostic solutions. The company offers IVD rapid prototyping, product development, and manufacturing, with decades of experience developing and commercializing medical devices. It operates under an ISO 13485:2016 Quality Management System and has developed products in oncology, veterinary medicine, chronic disease, infectious disease

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3PL planningbiobankingbiomarker discovery and validationcassette engineeringcell culturingconjugation scale-upcustom surface chemistryELISAIVD manufacturingIVD rapid prototypinglateral flow assay developmentlateral flow developmentLuminexlyophilizing reagentsMSDproject managementQMS integrationreagent formulationtech transfer management

Founded in 2002, Cellex Incorporated is a biotech company that develops technologies, instruments and assays for testing human diseases and conditions, particularly for point-of-care (POC) professional healthcare settings. Based in Morrisville, NC, it maintains a GMP manufacturing site in Suzhou, China (ISO 13485 certified, FDA QSR) and an exclusive manufacturing partner in Zhengzhou. It has a lineage of more than 50 IVD diagnostic products.

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GMP manufacturingHomogeneous Biochemiluminescence Assay (HBA)Lateral Flow Chromatographic ImmunoassayReal-Time PCR (qPCR)