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INNOVATION

Research & Development

Since 2002, our R&D has focused on developing a simple and reliable panel screening test for neurodegenerative diseases with our platform technology, Multimer Detection System (MDS). Originally, MDS was designed to specifically detect prion oligomers in blood. After having developed Prion Scrapie blood test, MDS was applied for the diagnostics of Alzheimer’s disease (AD) and focused on developing a simple blood diagnostic tool for AD. Our R&D have completed the development of AD blood test kit, “inBlood OAβ Test” and it’s currently in process of FDA approval in Korea. As a big step forward for the completion of blood screening panel for neurodegenerative disease, the development of blood test for Parkinson’s disease by detecting oligomerized Alpha Synucleins (α-Synuclein) has been undertaken upon confirmation of great preliminary results.

Measuring CSF Biomarker (Aβ42, p-Tau, t-Tau)

Measurements of biological markers in the cerebrospinal fluid (CSF) can be used as supplemental tests to aid in the diagnosis of Alzheimer’s disease. A low level of beta-amyloid 42 (Aβ42) with high level of total tau (t-Tau) and phosphorylated tau (p-Tau) in CSF reflects an increased likelihood of AD.

Measuring Oligomerized Aβ

Soluble oligomers of beta-amyloid (Aβ) are now widely believed to be the toxic form in the peptide. Oligomeric forms of Aβ are known to suppress learning and memory, and kill neurons in various experimental systems. Measuring Oligomeric Aβ is directly related to the onset of AD. Using MDS platform technology, PeopleBio developed AD blood test, a simple and reliable blood-based test to detect oligomerized Aβ from a plasma of AD patients.

Measuring Exosome (Aβ42, p-Tau, t-Tau)

Exosomes that enter blood from the central nervous system stand out as potential blood-based biomarkers for AD. Studies reported neuronally derived plasma exosomes in AD patients carry more Aβ42 and p-Tau. We can apply our highly sensitive ELISA technology to quantify the different protein levels in the exosomes.

Therapeutic Antibody

While we tried to generate and engineer high-affinity recombinant humanized monoclonal antibodies to improve the assay, 12 novel monoclonal antibodies were created from phage display. These antibodies target different terminal regions of Aβ with comparable or higher affinity to commercially available diagnostic antibodies. Some unique antibodies specifically target against conformational epitopes found on toxic oligomeric Aβ which could be developed as a new potential disease-modifying drug candidate for AD.

α-Synuclein

Large aggregates of misfolded α-synuclein form the characteristic Lewy bodies found in Parkinson's disease (PD) and other α-synucleinopathies. Measuring α-synuclein oligomer levels in body fluids of PD patients with MDS technology, we confirmed the potential utility of a specific α-synuclein oligomer measurement in preliminary experiment to put forward the development as a diagnostic test for PD.

FACILITY

Our R&D facilities and equipment are designed, maintained, calibrated and operated according to Standard Operating Procedures (SOPs) and researchers executing each study are well-experienced to perform assigned tasks. To ensure the quality and integrity of designed study for each R&D project, the study is performed in accordance with pre-defined protocol, SOPs, and Quality Management System (QMS). Test data and reports are reviewed by Quality monitoring team to ensure that the technicians followed the relevant test methods, SOPs, no errors occurred, and the integrity of study is maintained. We established our own GMP facility for production of medical device in compliance with FDA established quality system regulation to ensure the safety, purity, consistency, and reproducibility of produced IVD (in-vitro diagnostics).

Research and Development Center

The core of the PeopleBio, Inc., R&D center is committed to the development of pathfinding diagnostic products in neurodegenerative diseases based upon PeopleBio’s core technology. For researchers to solely concentrate on discovery and the development of innovative technologies, our R&D center is well equipped for carrying out researches which investigate into the etiology, pathogenesis, and diagnosis of neurodegenerative diseases. To ensure our R&D center to perform the highest quality of lab testing, PeopleBio will continue to reinforce R&D’s capabilities by facilitating state-of-the-art instrumentation and technology to combat devastating neurodegenerative diseases.

GMP Facilities

To ensure the safety, purity, consistency, and reproducibility of produced IVD (in-vitro diagnostics), PeopleBio established its own medical device production facility in compliance with FDA established quality system regulation under the Code of Federal Regulations (CFR). We believe extensive control and validation process determines product quality that can impact critical medical decisions. From R&D center to GMP, we aim to make easy transition from RUO to IVD by aligning specifications and methods from research to GMP. Our GMP is ready to facilitate OEM services for manufacturing in-vitro diagnostic medical devices and antibody based immunochemistry diagnostic tests, and ensure that your products are made to your specifications with 100% process control and traceability.