Medicilon currently features a cGMP-based API production line based on IND requirements. From preclinical laboratory-scale testing and process development to commercialized production, we meet the needs of our clients throughout the comprehensive supply chain, including R&D, purchase and production. From the mg- and g-level to kg level, our processes allow flexible adjustments to fit in client innovative process R&D and scale production.
From QBD-oriented process design to process R&D in laboratories, commercialized production to data-based filings, our analysis and quality inspection teams promise professional services and comprehensive analytical research, including method development and verification, process verification, impurity identification and separation, API and intermediates research, and API stability tests.
With years of experience and the construction of laboratories, the Medicilon Process Department can not only perform R&D, testing and stability studies of generic drugs for customers, but also R&D, production, testing and stability studies of innovative drugs in clinical phase I and phase II, gradually developing from process R&D to industrial commercial production and transforming from CRO to CDMO.
Generally, an API involves multiple process routes. The selection of routes will affect not only the possibility of industrial manufacturing, but also the material cost, product quality, and even the environment. We provide services that include the customization of initial API, as well as the design and determination of synthetic routes. With our research into products to be developed and information checked, we will analyze the feasibility of such routes, and the source of synthetic materials, to check if such routes are involved in intellectual property issues, if the cost is acceptable, and if such routes are in compliance with green chemistry principles. After that, we will conduct route selection, process optimization, quality research, and process verification to ensure project quality.
Our Process Department employs the principle of QBD in API process development ,and strives to select the best route suitable for our clients, optimizing the API production process to improve product quality and manufacturing efficiency.
We offer API production services, including production for laboratory-scale testing, batch production for safety evaluations, production for pilot-scale testing, and GMP-based production. Our lab can support the production of clinical API for phase I and phase II, as well as advanced intermediates.
The production of APIs often involves complex chemical and biological changes. As the production processes are based on chemical unit reactions and chemical unit operations, resulting in by-products, purification and refinement is necessary. Impurities such as API-related substances, residual organic solvents, and inorganic impurities, as well as their physical and chemical properties, the stability of APIs, and the possibility of contamination and cross-contamination are key considerations regarding the quality, safety and effectiveness of APIs.
Medicilon offers API related services including impurity identification and separation, as well as quality research and stability testing.
We provide drug master file (DMF) services for the API manufacturing process of generic drugs.
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