In general, the work done in a laboratory cannot be simply multiplied up to an industrial scale because of the inevitable consequences of increased scale, such as a decrease in surface area and volume ratio. This may seem insignificant in the lab (for example a bit of foam), but it may be significant at industrial scale (the bit of foam has its own structure and impedes the addition of other materials).
Creative Biolabs has the integrated project teams that are supported by a highly experienced and dedicated group of scale-up chemists. We can understand the ultimate goal of your drug discovery project and the challenges you face in moving from lead optimization to preclinical research. Our team is able to carry out process and scale-up chemistry, and help you with a smooth transition from discovery into pre-clinical development, and subsequent GMP manufacture.
The task of process and scale-up chemistry is to identify a safe, cost- and labor-effective, "green" and repeatable chemical processes. When looking for the shortest, most efficient synthetic route, optimal reaction conditions must be devised to eliminate expensive functional group operations and oxidation or reduction steps. The ideal chemistry process can work very well in different kinds of metrics. Therefore, large-scale pharmaceutical process and manufacturing departments need to select the most suitable path for scale-up chemical production by optimizing the reaction conditions.
Choosing the right route is the key point to ensuring and supporting process and scale-up that is rapidly evolving and expanding. In the route scouting and development, lots of integrated routes have been proposed and explored. These routes are designed using the available literature and the wealth of experience of our team. To achieve this goal, different aspects are considered: process safety, environmental impact, cost, atomic efficiency, reaction quality efficiency, quality and delivery, and the sustainable development of the pharmaceutical industry.
Unlike laboratories, impurities are generally not accepted in industrial process because contaminants may render the product unacceptable. The usual purpose of industrial production is to reduce impurities, which means to increase yields and produce better products. As it may be impractical or too expensive to completely remove every impurity, the general question is which impurities to remove and which ones to control. The pharmaceutical industry has strict guidelines on the level of acceptable impurities, so it is necessary to have impurity characterization and management according to the guidelines.
The API reference standards can be prepared by drawing raw materials from a GMP batch. A specification reference standard and certificate of analysis will be issued. The reference standard can be described in a variety of ways using many spectroscopic and chromatographic techniques: including measuring the exact molecular mass determined by reflectron QTOF MS analysis, calculating amino acid ratio obtained by amino acid analysis and so on.
Creative Biolabs is focus on providing customers with process and scale-up service. Various technologies such as MS, NMR will be provided in the process. We are happy to hear from you and look forward to working with you.
For lab research use only.