SK pharmteco specializes in the commercial and clinical production of APIs, Advanced Intermediates, Registered Starting Materials and Key Building Blocks. Our offerings include process R&D, analytical method development and stability, scale-up and optimization, validation and commercial production of small molecules as well as extensive Adeno-Associated Virus (AAV) and Lentiviral vector development and cGMP production capabilities.
Our global operations include 7 cGMP manufacturing and development facilities across the US, Korea, Ireland and France. We also operate dedicated analytical services facilities.
We have a strong record of environmental, health, and safety performance. All our plants have been successfully audited by global regulatory agencies including the FDA (US), EMA (Europe), PMDA (Japan), & MFDS (Korea).
Extensive technology toolbox and ~1,000 m³ of global small-molecule capacity plus 5,000 m² of viral vector facilities.
Products & Services
SK pharmteco is a leader in operational excellence and continuous improvement. Our highly skilled team delivers innovative solutions across the following offerings:
– Continuous Flow Processing
– Chromatography: SMB & Batch
– High Potency (Up to 4 m³ scale & down to 10 ng/m³ containment)
– Energetic Chemistry
– Controlled Substances (US DEA Schedule II-V Manufacturing)
– Particle Engineering
– cGMP Manufacturing in Adherent & Suspension Systems for Viral Vectors
– Analytical & Process Development for Viral Vectors
We provide full regulatory support for all aspects of compliance including supporting PAI’s.