SK pharmteco’s SmartPure
Simulated Moving Bed and Batch Chromatographic Separation Processes
SK pharmteco is a global leader for continuous & batch chromatography.
SK Pharmteco (SKPT) has the largest CGMP Simulated Moving Bed (SMB) unit in the United States. We have also expanded our SMB technologies, offering (4.6 mm to 1,000 mm columns) by adding high-pressure preparative batch chromatography capabilities for difficult separations (oligonucleotides and other complex molecules) using column diameters from 10 mm up to 800 mm. These technologies and this expertise are an integral part of SmartPure, a one-stop shop for gram to multi-tons scale purification under CGMP guidelines. It can be utilized as a standalone service or in conjunction with other SK Platforms.
What is our specialty?
Our technology platforms are designed for robust, scalable, and efficient processes through the combination of engineering, chemical, and analytical expertise.
The SmartPlatform Portfolio provides the consistent integration of capabilities to support development and manufacture from lab to commercial scale. Our expertise in route development and manufacture at all scales using unique technologies means fewer steps, faster turnaround times, increased efficiency, and lower costs. SKPT offers complete manufacturing solutions under CGMP under stringent regulations and safety protocols.
Our offerings can support clinical to commercial-scale capabilities, incorporating expertise in route and method development, all available in-house.
This allows fewer steps, faster turnaround times, increased efficiency, and lower costs. Finally, this is done under CGMP guidelines at facilities worldwide, under the strictest regulations and safety protocols.
SK pharmteco’s SmartPure
Simulated Moving Bed and Batch Chromatographic Separation Processes
Plug & Play
Each technology platform is fully integrated within the SKPT SmartPlatform Portfolio. As a result, each technology can be transferred and seamlessly integrated across all our facilities. All data is organized, managed, tracked, and maintained to ensure CGMP compliance and transparency with our customers.
Productivity & Scalability
SmartPure is designed to provide a systematic approach for the development of chromatographic processes to assess a separation rapidly. Within a few weeks, our team will provide a feasibility study with accurate estimates of commercial-scale manufacturing for both batch and continuous separations. Our chromatographic processes are scalable from gram to multi-metric tons with minimum additional development required.
Time- & Cost-Savings
With the SmartPure technology platform, our experts can assess the feasibility of the chromatographic separations and estimate the production rate and manufacturing costs of the route. This gives our customers the necessary data to make informed decisions and ultimately reach the market faster with a fully scalable process.
Analytics
Our technology platforms are closely associated with data analytics to provide our customers with Key Performance Indicators. SKPT is moving towards digitalization to increase customer value and monitor and improve all our processes.
Robustness
SmartPure offers robust technology solutions for the purification of APIs and intermediates, providing consistency in throughput and quality at all scales.
Expertise
With over 100 years of combined experience, our team evaluates chromatographic processes, batch or continuous, with production in mind, making the scale-up straightforward to our larger assets. Our SMEs also provide our customers with all the data necessary to support regulatory filings and patent submissions.
Safety
All SKPT facilities adhere to the motto “Safety First, Quality Always.” These two essentials are at the heart of our process development and manufacturing capabilities. Regardless of the chemistry, our experienced team of technical professionals always spends the necessary time to assess the associated hazards with the process to ensure a safe scale-up at all our plants.
Regulatory Support
Our Quality/Regulatory team is experienced in interacting with regulatory agencies worldwide to support our customers with their filing. Through process development reports, critical parameter evaluations, or site audits, our chemists, engineers, and regulatory experts are experienced in bringing your product from development to commercialization through successful validation. Our track record with the regulatory agencies is impressive. Our success rate in Pre-approval Inspections ensures that validations and product launches occur without any regulatory concerns. Our history even shows a significant number of inspections being waived due to the high quality of our systems.
Project Management
Our Project Management Group has end-to-end responsibility for the assessment and execution of your program. The PM team will work closely with you to understand your needs and objectives and develop a plan to initiate and execute project deliverables. Once a project is awarded, a Project Manager will be assigned who will become the key point of contact for the Customer. The PM will be supported by an internal integrated cross-functional team responsible for project delivery. We will work with you to agree on the optimum arrangements for managing all elements of your project and enable the highest level of collaboration and problem-solving across technical groups. Timely, accurate, and transparent communication is vital to the success of our projects, and we maintain the highest levels of integrity in all our activities. Our ultimate goal is to deliver your project on time and right the first time.
