SK pharmteco’s SmartShield
Highly Potent Chemistry for APIs and ADC payloads
SK pharmteco is the leader in the synthesis & purification of highly potent compounds for use in the pharmaceutical industry.
SmartShield can be utilized as a standalone service or with other SK pharmteco (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.
SK pharmteco’s SmartShield
Highly Potent Chemistry
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
SmartShield is designed to provide customers with R&D and commercial capacity to synthesize highly potent compounds with an OEL (Occupational Exposure Limit) as low as 10 ng/m3 in suitably designed equipment up to 90 L for OEL < 100 ng/m3 and 2,000 for OEL < 1.0 ug/m3, in a reliable and scalable manner.
Cost- and Time- Savings
Designed to be time and cost-effective, reducing production hours and increasing output, SmartShield is specifically designed to streamline development and production activities. Our significant expertise in handling highly potent compounds and complex chemistry allows the development and implementation on a scale of the most efficient processes. Our extensive internal technical capabilities, from process safety to analytical testing, ensure that our processes can be scaled quickly and efficiently.
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.
SmartShield ensures that all potent compounds are handled safely by optimized process design, use of appropriate engineering controls, and adherence to strict administrative controls and procedures. This facilitates a resilient and robust process and project flow.
SK pharmteco expertise consists of decades of experience in developing and manufacturing highly potent compounds, including APIs, at any stage of the product lifecycle (from pre-clinical to commercial). In addition to in-house independent CGMP-compliant manufacturing facilities for highly potent compounds, SK pharmteco maintains R&D laboratories dedicated to high-containment chemistry and a dedicated facility for preparing and handling highly potent compounds.
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.
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.
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.