Small Molecule Platforms CDMO Services

SK pharmteco has a rich history in catalyst development and manufacturing, specializing in catalysts optimized for continuous flow processing. These catalysts offer higher selectivity, improved impurity profiles, safer operating conditions, and more predictable small molecule synthesis processes at scale, leading to cost-effective manufacturing. SmartCat boasts an extensive library of metals supporting various chemical transformations. We offer manufacturing solutions from laboratory to commercial scale under CGMP using off-the-shelf and product-specific catalysts, which can be designed and manufactured in-house to meet specific needs.

SK pharmteco’s SmartShield solution, designed for safe scalability, streamlines the development and production of highly potent APIs (HPAPIs) with minimal occupational exposure while increasing output. With extensive internal technical capabilities from process safety to analytical testing, our processes can be scaled quickly and efficiently. SmartShield provides customers with R&D and commercial capacity to reliably synthesize HPAPIs with occupational exposure limits (OEL) as low as 10 ng/m3, in suitably designed equipment up to 90 L for OEL < 100 ng/m3, and 2,000 L for OEL < 1.0 ug/m3.

Our SmartForm Platform is a particle design solution spanning from crystallization to drug particle engineering. SmartForm is designed to provide opportunities to improve the physical characteristics of small molecule intermediates and APIs in a reliable and scalable manner. Our crystallization expertise allows particle size control, improved yields, optimized impurity rejection, and improved product isolation. Particle size reduction can also be achieved via a range of milling technologies, including wet-, pin-, and jet-milling. SmartForm can also support the development, improvement, and implementation of a spray drying process under non-CGMP conditions to meet API solubility needs. With comprehensive material testing capabilities, SK pharmteco can investigate relationships between your product’s performance and physical attributes to develop and optimize production processes.

SK pharmteco is an innovative leader in small molecule development and manufacturing using continuous flow processing. Our SmartFlow Platform is designed to provide an efficient, seamless transition into a commercial continuous process based on prequalified modules that can be assembled in days to create a CGMP-operating manufacturing line. This modular, ‘Plug & Play’ design allows quick transitions between processes using our existing module library, with ongoing expansion to handle new chemical transformations. SmartFlow streamlines development and scaling, reducing production hours and increasing output for cost savings and minimal downtime. Our experts are flexible and responsive, supporting rapid development in fully continuous and hybrid processes.

SmartPure is an all-in-one solution for gram to multi-ton scale purification of drug substances under CGMP guidelines. The platform is designed to provide a systematic approach to the development of chromatographic separation processes, giving partners complete insights into the feasibility, production rate, and manufacturing costs of a batch or continuous chromatographic separation route. With over 80 years of combined experience, our expert team evaluates processes with production in mind to make scale-up straightforward and cost-effective.

SmartTest is an analytical testing solution for pharmaceutical intermediates, formulated drug products, and APIs, including highly potent and cytotoxic compounds as well as controlled substances. We can build a strong analytical foundation with the product lifecycle in mind, focusing on phase-appropriate method development and validation while staying efficient. With an impressive record of regulatory training, the experts behind SmartTest supply the support required for regulatory filings and patent efforts. Using SmartTest as your dedicated analytical service frees up critical resources, allowing you to focus on other key development tasks.