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We are committed to the process development, optimization and impurity characterization of organic intermediates and pharmaceutical APIs with high technical barriers, great difficulty and high added value. We have completed nearly 20 new drug process development projects for many pharmaceutical R&D companies and more than 100 new chemicals process development projects for chemical companies.
Our innovation continues, with ongoing product & process optimisation and long term continuous improvement. Examples of our approach can be seen in these Case Studies.Our service is completely confidential. To discuss your requirements, in confidence, please contact us.
Synbest provides contract and toll manufacturing services both with and without the provision of the customer's process and Intellectual Property (IP). In the case of manufacturing according to customers-provided IP, we offer strong corporate policies on Intellectual Property (IP) protection, ensuring that your projects are handled in the strictest of confidence at all times.
Our R&D laboratories are staffed by highly skilled teams of Research Chemists with a wide range of synthetic experience; being experts in process development, scale-up and optimisation. We can offer the following services:
? Synthetic route development
? Process scale-up from grams to multi-tonne quantities
? Process optimisation
? Continuous improvement activities
? Confidentiality and exclusivity
? Full analytical support including NMR, HPLC, GC-MS, UV-Vis spectroscopy.
We have a culture of continuous improvement. Our Process Improvement Groups review processes to improve the quality, safety, and efficiency of chemical manufacturing campaigns. This is all part of our approach to providing the highest quality of products for our customers.
We always take scientific research as the first task, take the customer as the center, carry out testing and analysis work under strict procedures, provide customers with product testing and quality control solutions, and wholeheartedly provide customers with professional and scientific inspection and testing, research and development analysis services, and effectively help customers develop new projects.
Our professional analytical and QC team provides customers with a full range of services from intermediates and apis to formulation development, including analytical method development and validation, release testing and stability studies.
? Development, validation and transfer of analytical methods to meet ICH requirements
? Process control and release testing in accordance with GMP requirements
? Forced degradation studies for impurity or degradation product detection
? Stability studies at different temperatures and humidity
? Use prep-HPLC, LC-MS, GC-MS, FT-IR, NMR, elemental analysis and other advanced equipment for impurity separation and identification
? Differential scanning calorimetry (DSC)
? Development and validation of methods for analysis of genotoxicity and elemental impurities
? Reference standard characterization and identification
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