We use cookies to understand how you use our site and to improve the overall user experience. This includes personalizing content and advertising. Read our Privacy Policy
Accept Cookies
At Protheragen AI-Pharma, we offer tailored GMP manufacturing solutions designed to meet the diverse needs of our clients in the pharmaceutical and biotechnology industries. Our expertise spans a broad range of services, including small molecule drug CDMO, small nucleic acid drug CDMO, and formulation development and scale-up production, supporting from preclinical to commercial stages. Delivering timely, high-quality, reasonably priced active pharmaceutical ingredients (API) and final formulation dosages is Protheragen AI-Pharma's ultimate commitment.
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 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.
Based on synthetic biology technology and liquid phase molecular synthesis technology, Protheragen AI-Pharma is committed to the research and development of new liquid phase and liquid-solid coupling synthesis technology and production process, providing the research and development, production and process of a series of products such as modified nucleotide monomers, nucleoside phosphoramidites, oligonucleotides, and cyclic dinucleotides.
Protheragen AI-Pharma offers comprehensive formulation development and GMP-compliant scale-up production services designed to support the successful transition of your product from concept to market. Our formulation development process begins with in-depth pre-formulation studies to assess the API's characteristics and compatibility with excipients. We leverage this data to design robust, efficient formulations tailored to your specific needs, until this formulation can be seamlessly transitioned to scale-up production. Protheragen AI-Pharma meticulously adheres to Good Manufacturing Practice (GMP) standards, optimizing the manufacturing process to maintain consistency, quality, and regulatory compliance throughout.
Custom Development Capabilities: From traditional formulations to novel drug delivery systems, Protheragen AI-Pharma is capable of gathering all resources to meet customers' formulation development needs.
Process: Pre-formulation Evaluation & Design→ Formulation Development→ Analytical Methods Development→ Process Validation→ Batch Production for Trials→ Stability Testing→ Pilot-Scale Production→ Technology Transfer→ Process Validation→ Cleaning Validation→ Product Quality Testing → Documentation and Regulatory Submission→ Full-Scale Production→ Ongoing Stability Monitoring→ Process Optimization.
Our zeal for finding solutions to challenging drug development problems motivates us at Protheragen AI-Pharma. Protheragen AI-Pharma has adopted sustainable methods in pharmaceutical manufacturing and process development as part of our unwavering commitment to excellence. Prestigious international regulatory agencies, such as the FDA (USA) and NMPA (China FDA), have routinely passed rigorous PAI inspections and routine audits of the manufacturing facilities, demonstrating our dedication to upholding the highest standards of quality and safety.
Selecting Protheragen AI-Pharma as a partner entails working with a pioneer in the development of green processes, someone who infuses each project with a unique blend of quality, innovation, and environmental responsibility. Come along as we create a healthy future.
For more information or to discuss how our customized GMP manufacturing services can support your projects, please contact us.
Our mission is to accelerate the development of life-saving drugs by leveraging cutting-edge AI technologies.
Certification
