SK pharmteco’s SmartForm
Material Science Solutions
SK pharmteco is a global leader in particle design, from crystallization through particle engineering.
SmartForm can be utilized as a standalone service or with other SK pharmteco (SKPT) Platforms.
Material Science is intended for designing intermediates and APIs to:
- Give the correct solvate and hydrate.
- Reduce particle size through milling and micronization.
- Give the correct crystal polymorph.
- Assist with spray drying development.
- Design amorphous solids.
- Co-develop with drug product formulation.
- Improve filtrations and isolations for better manufacturing performance.
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 SmartForm
Particle design, from crystallization through particle engineering.
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
SmartSize is designed to provide opportunities to improve the physical characteristics of intermediates and APIs with the on-scale capability to implement efficient crystallization/isolation/drying conditions and particle size reduction via milling in a reliable and scalable manner. SK pharmteco’s SmartSize Platform can go from lab to commercial scale, all within a CGMP environment. The platform can also support the development, improvement, and implementation of a spray drying process under non-GMP conditions to meet API solubility needs.
Time- & Cost-Savings
Designed to be time and cost-effective, reducing production hours and increasing output, SmartSize is specifically designed to streamline development and scaling activities. With our strong understanding of the linkage of API physical characteristics with DP formulation and utilizing SmartSize particle engineering capabilities from bench to plant and extensive internal physical characterization testing capabilities, projects can be fully supported at one site.
SmartForm utilizes well-established and extensive material physical characterization testing capabilities. With SK pharmteco’s expertise in statistical analysis (e.g., DOE, MVA), we can develop/optimize crystallization or milling procedures and investigate relationships between your product’s performance and its physical attributes. It is tested with proven and optimized analytical methods, and we provide an understanding of the testing and exactly where your project is within the workflow. All analytics are integrated within the platform and reported to you by your dedicated Project Manager.
SmartForm ensures that robustness has been built into the development and implementation of efficient processes, leveraging the extensive analytical testing capabilities to monitor and modify, as appropriate, processing conditions to maintain the process in a state of control throughout the lifecycle.
SK pharmteco expertise consists of decades of experience in the development and manufacture of chemical compounds at any stage of the product lifecycle. Our expertise and extensive testing capabilities in material physical attributes (PXRD, DSC, TGA, DVS, surface area, material flow properties and rheometry, optical and hot stage scanning electron microscopy, FT-IR/NIR, Raman spectroscopy). 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 available within SK pharmteco (wet-, pin- and jet-milling) at multiple scales from lab to CGMP plant scale.
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.