Leadgene Biomedical, Inc. - Fueling Breakthroughs & Innovation

As a pioneering manufacturer of recombinant proteins and antibodies, Leadgene Biomedical provides a comprehensive suite of platform development services, including lateral flow assays, ELISA kits, antibody engineering, and pharmacokinetic analysis.

We support our clients in establishing IVD platforms, offering end-to-end solutions from material design and production to system setup and assay manufacturing.

Our services can be bifurcated into two key categories:
A. Diagnostic Platform Development
a. Raw Materials
With an edge in antibody design, engineering, and development, Leadgene delivers high-quality, stable antibodies and recombinant proteins backed by an ISO13485-certified manufacturing system. We are a top choice for IVD raw materials, committed to delivering excellence and unmatched product specificity, sensitivity, and stability to our customers.

b. Lateral Flow Assay
Leadgene showcases exceptional innovation in diagnostic platform development. We responded swiftly to the SARS-CoV-2 pandemic by rapidly developing a broad range of premium COVID-19-related products and antibodies. We are proficient in developing highly sensitive, stable antibodies and proteins for lateral flow assays and assist clients in developing these platforms through antigen/antibody development, assay design, and uncut sheet manufacturing.

c. ELISA Assay
Leadgene excels in the development of rare antibodies, such as small molecular antibodies. We have successfully developed anti-indoxyl sulfate antibodies (anti-IS antibodies) and the corresponding IS ELISA Kit. Our LEADGENE® Indoxyl Sulfate (IS) ELISA is the world's first CKD detection CE-IVD, offering rapid, highly sensitive, cost-effective, and user-friendly monitoring of IS levels. We are not just pioneers in ELISA development but also proud holders of several global patents and the CE-IVD certification.

B. Biologics CDMO/CRO
If you're looking to kickstart your biologics research, Leadgene is your reliable partner. We offer a one-stop CDMO/CRO solution for protein/antibody development, antibody humanization, pharmacokinetic analysis, and cell line development. Our cell line development service includes establishing the cell bank, scaling up the cells, and assessing cell characteristics.

At Leadgene, we prioritize quality management for our products and services. Our professionalism is evident in our meticulous attention to detail. We are committed to relentlessly pursuing innovation and continuing to make significant contributions worldwide.