SK pharmteco is an innovative leader in developing & manufacturing using continuous processing.
We have a long and rich history of successfully and safely manufacturing chemicals using continuous processes at all scales and multiple sites. SK pharmteco (SKPT) provides development and manufacturing experience for gram to multi-tons. The SmartFlow Platform is an integral part of a one-stop shop for gram to multi-tons scale production, under CGMP guidelines. It can be utilized as a standalone service or in conjunction with other SKPT 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.
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
SmartFlow is designed to provide rapid development of continuous processes to support CGMP kilo, pilot, and commercial in a reliable and scalable manner. The concept of this process design is to provide a more seamless transition into a commercial continuous process. SK pharmteco’s SmartFlow is based on prequalified modules that can be assembled in days to provide a manufacturing line operating under CGMP. This modular approach is well characterized and can be scaled to provide the required quantities to support clinical development through commercial manufacturing at a fraction of the cost.
Time-Savings
Designed to be time and cost-effective, reducing production hours and increasing output, SmartFlow is specifically designed to streamline development and scaling. Utilizing SmartFlow as your dedicated continuous processing service can result in cost savings with fast development and minimal downtime. Our continuous processing experts are flexible and responsive in supporting rapid development in fully continuous and hybrid processes. Our Plug & Play design allows us to quickly transition between processes using our existing library of modules. We are continually designing and building new modules to expand our library to handle new chemical transformations, and we welcome a challenge in designing a process for a new transformation.
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
When we develop our continuous processes, they are fully characterized to provide a robust solution. Our SmartFlow platform uses an engineering approach and digital twins to provide a deeper understanding of the process to reduce variability and failures. Our expertise in operating continuous processes provides processes with consistent quality attributes.
Expertise
Our history in the continuous processing space has evolved from the petrochemical and aerospace industries to apply this technology to manufacture pharmaceuticals under CGMP at multiple sites. SK pharmteco has been performing continuous chromatographic purifications for over two decades using SMB to support commercial-scale API production up to hundreds of metric tons per year. Continuous catalytic hydrogenation under high pressure and temperature is a core technology from bench to commercial volumes. Our facilities include CGMP kilo-scale and pilot-scale units to support smaller quantities. Additionally, SKPT has launched a cart-based design to enable continuous processes at an earlier stage of drug development. SK pharmteco has in-house equipment development and automation capabilities, along with modeling and simulation tools, to facilitate the most efficient path.
SmartFlow features include:
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 well experienced in interacting with regulatory agencies from around the world to support our customers with their filling. Through process development reports, critical parameters evaluation, or site audits, our teams of chemists, engineers, and regulatory experts are well-experienced in bringing your product from development to commercialization through successful validation. Our track record with the regulatory agencies is impressive: more than 30 pre-approval inspections over the past decade, with 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.
