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Leinco, founded by Patrick Leinert Sr. in 1992, is a specialty manufacturer of research products including antibodies, recombinant proteins, and ELISA kits with a commitment to verified and validated results.
IPM What makes Leinco stand out as a CDMO Services provider?
The growing team of scientific staff at Leinco has carried on the commitment to quality with expanded capabilities to include CDMO services for antibody conjugation, large-scale GLP manufacturing, and assay development to manufacturing of in vitro diagnostics (IVD), having partnered on over 100 such projects.
Beyond offering cutting-edge research and diagnostic reagents, the Leinco team also works closely with customers to understand their needs and guide them to the best solution. This may be in the form of an off-the-shelf antibody reagent or may lead to the discussion of a custom antibody development service or assay for their specific study or project. The combination of a collaborative approach, high-quality antibody reagents, and robust assay development processes are critical success factors to the reproducibility of an IVD assay for infectious diseases (e.g., influenza, SARS CoV-2, monkeypox), cancer, or other areas.
IPM Can you elaborate on the process for assay development?
Partnership and quality are fundamental to our four-step approach in assay development. We begin with planning which includes collaboration of design, antibody selections, and proof of concept. Step two is development, which focuses on assay optimization, integration of cassettes, sample handler, and reader systems, and performance verification. Next comes validation, which includes sample testing, QC assay performance qualification, and validation that the product meets the customer’s specifications. Finally, step four is cGMP manufacturing. In this step, we scale-up manufacturing, employ bulk production, perform lot release testing, and deliver the final kits along with documentation.
As part of the four-step assay development process, our partners can leverage the “Leinco Way”:
Partnership
• Highly experienced scientific and skilled project management staff
• Focused on transparent communication at every project stage and on recommending data-driven decisions
Process
• Stringent quality and adherence to ISO 13485 standards Proficiency
• Achieving goals more quickly using our biomarker immunoassay development and manufacturing experience for drug discovery and diagnostic applications
More about the outcomes of working closely on a lateral flow-based diagnostic assay can be found in our case study on Influenza A.
IPM Can you share an example of a partnership to develop an assay?
With a proof of concept for a novel cancer diagnostic assay in-hand, a biotech company approached Leinco interested in verifying and validating this assay. It quickly became apparent that an alternative assay platform would be needed in order to make the assay more patient-friendly. Collaboration and transparency, two things Leinco prides itself on, were critical to this customer. They wanted to be able to work alongside the scientists at Leinco, review the data as soon as it was generated, and understand the next steps to progressing the project. This continuous dialogue and detailed documentation enabled us to combine our technical expertise and knowhow with their understanding of the disease state and unmet market needs.
We welcomed this hands-on collaboration and will continue to encourage both new and long-standing customers to take this approach with us on future projects.
For additional information: www.leinco.com
