SK Biotek

www.skbiotek.com

Watery Lane
Swards
Dublin

Ireland

Activities

Summary

SK biotek is a global life science company known for its presence in custom chemical development, advanced intermediates and active pharmaceutical ingredient (API) manufacturing. We have extensive experience in custom development from clinical phases to commercial manufacturing for global pharmaceutical markets

Profile

SK pharmteco - a new name with 75+ years’ experience…

SK pharmteco is the single market-facing team comprised of SK biotek and AMPAC Fine Chemicals. Creating substantial market synergies in the API CDMO space by combining highly complementary assets and expertise this union enables us to provide the highest-quality services to our customers.

Our scientists and engineers are leaders in continuous manufacturing methodologies, having successfully developed processes from low kilograms through to 10s of tonnes

SK pharmteco is a wholly owned subsidiary of the South Korean conglomerate SK, a global leader in energy, chemicals and information technology; it is the cornerstone of SK holdings growth strategy.

With world-class state-of-the-art facilities and technology, increased capabilities: energetic chemistry, continuous flow process, controlled substances, particle engineering, high potency - with world-class potent handling capability (down to low nanogram per cubic meter levels). We have multiple cGMP manufacturing and development sites, with over 1020 m³ of capacity among 6 sites including USA, Korea and Ireland.

Our scientists and engineers are leaders in continuous manufacturing methodologies (tubular and fixed bed reactions and CSTRs), having successfully developed processes from low kilograms through to 10s of tonnes.

We are a world leader in Simulated Moving Bed technology (SMB) and offer this powerful technology from lab through pilot to large commercial scale. We have a proven track record in successfully developing processes involving highly energetic chemistry and now offer supply capability for Controlled Substances from our DEA-approved facilities in Virginia and California.

In addition to providing analytical development and validation for all of the products that we manufacture in our global network, we also provide this same service for other customers as a stand-alone business at our Analytical Services facility in California.

As leaders in operational excellence and continuous improvement and boast exceptional technical capabilities. The global presence of our highly skilled and experienced team offers total support from development through to commercial production including seamless project transfer and management plus flexibility in R&D and manufacturing.

We have the capability and capacity to support all your API and Intermediate needs across the full lifecycle

All our plants have been approved by global regulatory agencies including the FDA, EMEA, PDMA and Korean MFDS.

We specialize in the commercial and clinical production of APIs, Advanced Intermediates, Highly Potent APIs, Controlled Substances, Registered Starting Materials and Key Building Blocks. Our offering includes process research and development, analytical method development, scale-up and optimization, validation and stability.

We provide PAI and full regulatory support as well as complete confidentiality. We have a strong record of environment, health and safety performance.

With a strong technology toolbox and over 1020 m³ of global capacity, spread across three continents, we have the capability and capacity to support all your API and Intermediate needs across the full lifecycle.

We have been producing many of the world’s most recognized drugs for over 75 years. As an SK customer, you will have our commitment to work with you and your product as if it were our own.