SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology sectors with integrated solutions spanning small molecule synthesis, peptides, advanced modalities, and viral vector manufacturing. The company operates CGMP facilities across the US, Europe, and Asia, supporting clients from preclinical to commercial supply. Its offerings include process and analytical development, custom manufacturing, regulatory support, cell and viral banking, and the application of sustainable practices throughout the product lifecycle. Environmental responsibility, compliance, and innovation in manufacturing and analytics are core to their operations.
Industries
N/A
SK pharmteco
12460 Akron Street, Suite 100, Rancho Cordova, CA 95742, USA
Services
Custom design, optimization, and scale-up of synthetic routes for small molecule APIs, including risk assessments, route selection, and process transfer support.
Manufacturing of APIs at any scale under CGMP conditions, including highly potent and hazardous substances, with full project management and regulatory support.
CGMP production and supply of clinical trial materials, including APIs, intermediates, and substances for all clinical phases, with regulatory documentation support.
Method development, validation, transfer, reference standard management, physical and chemical characterization, raw material testing, and release testing for small molecules using advanced instrumentation.
Advanced analytical testing for trace nitrosamines and genotoxic impurities in drug substances and products using LC-HRMS, LC-MS/MS, and GC-MS.
Design and execution of ICH-compliant stability and forced degradation studies for drug products and substances, including storage, testing, and protocol preparation.
Custom design, optimization, and scale-up of synthetic routes for small molecule APIs, including risk assessments, route selection, and process transfer support.
Manufacturing of APIs at any scale under CGMP conditions, including highly potent and hazardous substances, with full project management and regulatory support.
CGMP production and supply of clinical trial materials, including APIs, intermediates, and substances for all clinical phases, with regulatory documentation support.
Method development, validation, transfer, reference standard management, physical and chemical characterization, raw material testing, and release testing for small molecules using advanced instrumentation.
Advanced analytical testing for trace nitrosamines and genotoxic impurities in drug substances and products using LC-HRMS, LC-MS/MS, and GC-MS.
Design and execution of ICH-compliant stability and forced degradation studies for drug products and substances, including storage, testing, and protocol preparation.
Expertise Areas
- Small molecule drug development
- API process development and manufacturing
- Clinical trial material production
- High-potency and energetic chemistry
Key Technologies
- Continuous flow processing
- Simulated moving bed chromatography
- High containment HPAPI manufacturing
- Solid-phase peptide synthesis
Key People
General Counsel
Vice President, Finance
Chief Commercial Officer
Chief Operating Officer
Head of Small Molecule, North America
General Counsel
Vice President, Finance
Chief Commercial Officer
Chief Operating Officer
Head of Small Molecule, North America
News & Updates
Achieved official validation of greenhouse gas emissions reduction targets by the Science Based Targets initiative.
Qualification of a large-scale viral vector manufacturing facility in Corbeil-Essonnes, France to CGMP standards.
Demonstrated regulatory compliance and successful completion of FDA inspection for the small molecule manufacturing site in Texas.
Invested $6.1 million to expand solid-phase peptide synthesis and purification capabilities in California.
Discussion of SMB technology benefits for API purification.
Webinar exploring challenges and solutions in small molecule development.
Achieved official validation of greenhouse gas emissions reduction targets by the Science Based Targets initiative.
Qualification of a large-scale viral vector manufacturing facility in Corbeil-Essonnes, France to CGMP standards.
Demonstrated regulatory compliance and successful completion of FDA inspection for the small molecule manufacturing site in Texas.
Invested $6.1 million to expand solid-phase peptide synthesis and purification capabilities in California.
Discussion of SMB technology benefits for API purification.
Webinar exploring challenges and solutions in small molecule development.