High Potent APIs

Our facilities use advanced containment systems and engineering controls to safely handle compounds with occupational exposure limits down to 10 ng/m³.

Our production ranges from milligram to kilogram quantities, supporting both clinical and commercial supply.

We support antibody drug conjugate services that include payloads and linkers development and manufacturing under strict safety and quality standards.

We have decades of experience producing highly potent compounds and has successfully translated this expertise to other modalities, including ADC payloads. We are a trusted launch and commercial CDMO for multiple oncology and virology therapies.

We provide access to powerful in-house analytical services to support HPAPIs, including ADCs payloads and linkers to ensure quality, safety, and compliance. These services include, analytical method development, validation and optimization, release testing, reference standard qualification, compound characterization, particle size analysis and material science, impurities analysis, stability, storage, and more.

SK pharmteco’s manufacturing excellence is demonstrated by a strong regulatory track record: 31 PAIs approved over the past decade, 9 recent PAIs waived, and 37 successful regulatory inspections since 2020, including two recently conducted simultaneously with no observations. Additionally, we have 39 approved products currently in production across all sites, underscoring our commitment to safety, quality, and compliance.