Monobind manufactures its products within a ISO 13485 Certified, CA Food and Drug Manufacturing Licensed, and a FDA Registered Establishment, following cGMP, FDA 21 CFR 820 and Part 210, in a 40,000+ square foot facility located in Lake Forest, California. Equipped with state-of-the-art automation, our facility supports large-scale production in compliance with GMP standards. We further promote worldwide sales with an immunoassay product and accessory line that is CE Marked.
From initial order entry to approval and raw material receipt to finished goods, an advanced CRP and ERP system integrates our operations. We have built proprietary software for QC and production departments, enabling total-quality management - from lot-number assignment and raw-material qualification to in-process QC, batch analysis, and final release. We support full traceability of product, utilize ink-jet identification on every product piece, innovative color-coding of components, and other features to ensure consistent and easy-to-use products.
Monobind employs a knowledgeable staff of renowned scientists, QC personnel, production experts, and supporting administrators. Dr. Frederick R. Jerome, Ph.D., an expert in immunoassay development and the president and founder of Monobind, oversees the design of the company's product line. And with more than 45 successful years in the biotechnology field, Monobind's team knows the value of efficiency, putting a premium on cross training departments, and implementing an advanced online manufacturing system that networks all operations.
