At Protheragen-ING AI-Pharma, we specialize in providing high-quality small molecule customized GMP manufacturing services. cGMP compliant manufacturing facilities, located in the USA and China, are dedicated to encompassing the complete lifecycle of drug production, from initial development through to large-scale manufacturing (mgs-tons). All sites boast a fully compliant cGMP laboratory and a multi-Kg scale cGMP commercial manufacturing facility. We specialize in:
Custom Synthesis Capabilities: Offering tailored synthesis solutions for complex molecules, from milligrams to tons at every stage ranging from Pre-clinical to Commercial Production.
Process: Feasibility Study & Planning→ Synthesis Development→ Analytical Methods Development→ Process Validation→ Impurity Isolation & Characterization→ Validation of Analytical Methods→ Pilot-Scale Production→ Commercial-Scale Production→ Stability Testing According to ICH Guidelines→ Quality Control Testing→ Documentation and Regulatory Submission→ Ongoing Stability Monitoring→ Process Optimization.
The manufacturing journey begins with a thorough consultation to understand your specific requirements, including drug formulation, scale, and production timelines. Our team of experts collaborates with you to define the project scope, establish technical specifications, and create a detailed manufacturing plan. This initial phase is crucial for aligning expectations and ensuring that all regulatory and quality requirements are addressed from the outset.
Once the planning phase is complete, we proceed to process development. Our scientists and engineers work to develop a robust, scalable manufacturing process for your small molecules drug. This includes optimizing synthesis routes, refining purification methods, and ensuring that the process meets GMP standards. We use state-of-the-art technology and analytical techniques to enhance efficiency, yield, and product quality.
With the process developed, we transition to scale-up and GMP production. Our facilities are equipped with advanced production systems designed to handle a range of scales, from small batches for clinical trials to large-scale commercial manufacturing. Throughout the production phase, we adhere strictly to GMP guidelines, ensuring that all processes are documented, validated, and executed with precision to produce consistent, high-quality products.
Quality is at the heart of our manufacturing services. We implement rigorous quality control (QC) and quality assurance (QA) measures throughout the production process. Our in-house QC laboratories conduct comprehensive testing, including raw material analysis, in-process controls, and final product testing, to ensure that every batch meets the highest standards of purity, potency, and safety. Our QA team oversees all aspects of compliance, documentation, and regulatory submissions to guarantee that our processes align with global standards.
Navigating regulatory requirements is a critical component of drug manufacturing. Our team is well-versed in the regulatory frameworks of various markets, including FDA, EMA, and ICH guidelines. We provide comprehensive documentation, including batch records, analytical reports, and validation documents, to support regulatory submissions and inspections. Our goal is to ensure that your product meets all regulatory requirements and facilitates a smooth path to market approval.
For more information or to discuss how our customized GMP manufacturing services can support your projects, please contact us.
We harness the power of artificial intelligence to transform the landscape of drug discovery. Our mission is to accelerate the development of life-saving medicines by leveraging cutting-edge AI technologies.
