- SK biotek’s new production line M3 has started operation to meet increasing orders from global pharmaceutical companies and demand from prospective new customers
- Once the M4 line is ready for production in 2024, the firm’s capacity and revenue are likely to increase two fold, expanding its pipeline of high value-added new drugs
- SK Inc., is fostering its CDMO business as a global top-tier player, significantly improving productivity and quality
SK Inc., the strategic investment holding company of South Korea’s SK Group, is expanding its pharmaceutical contract development and manufacturing organization (CDMO) capabilities with its eyes on the global market.
SK Inc. announced on October 4 that SK biotek, a CDMO subsidiary, has started the operation of its newly constructed M3 line in September. SK biotek is a Korean subsidiary of SK pharmteco, a global CDMO operation, wholly owned by SK Inc.
Located in Myeonghak General Industrial Complex in Sejong, SK biotek's Sejong plant has expanded its production capacity by approximately 50% from 190㎥ to 290㎥, which is equivalent to an annual capacity of 150 tonnes of small molecule active pharmaceutical ingredients (APIs). In response to growing orders, SK biotek launched a two-year project worth KRW 56 billion in 2020 to establish the M3 line.
With the addition of the M3 line, SK biotek’s annual sales are projected to increase over 1.5-fold from about KRW 150 billion in 2021 to KRW 220 billion in 2022. SK pharmteco recorded sales of KRW 830 billion in 2021, and its annual sales is likely to exceed KRW 1 trillion within the next two to three years, once ongoing capacity additions by subsidiaries in Korea, the U.S., and Ireland are complete.
SK biotek manufactures APIs for breakthrough drugs in diverse therapeutic areas such as diabetes, gastroesophageal reflux disease (GERD) and central nervous system diseases and exports to the US, Europe, and Japan. As SK biotek has been globally recognized for its ability to supply high-quality APIs, its order intake from major global pharmaceutical companies has increased over 20% every year since 2015.
The increase in orders from major pharmaceutical companies is attributable to SK biotek's continuous flow processing and high quality control capabilities, which are deemed among the world’s best. Continuous flow processing enables automated non-stop production throughout the whole processes. It is an eco-friendly technology that has superior cost competitiveness, productivity, quality, and safety compared to traditional batch processes and can significantly reduce waste generation. SK biotek is the first CDMO in Korea to introduce continuous flow process, meaningfully improving the productivity of API production.
Based on these operational and quality control capabilities, SK biotek's Sejong plant has achieved current Good Manufacturing Practices (cGMP) certification from regulatory authorities around the world including Korea’s Ministry of Food and Drug Safety, the US Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Australia’s Therapeutic Goods Administration (TGA). In addition, it has secured global competitiveness in the field of safety and environment by obtaining ISO 14001 and ISO 45001, international standards for environmental management and occupational health and safety, respectively.
“Equipped with distinctive technology and quality control capabilities, SK biotek has been a trusted partner for global pharmaceutical companies and is seeing a steady increase in new order intake,” said Keun-Joo Hwang, CEO of SK biotek. “SK biotek is set to expand its production capacity to 400㎥ with the completion of the M4 line in the second half of 2022 and is committed to positioning itself as a global-leading CDMO.”
SK pharmteco, established in 2019 as a holding company of SK Inc.’s CDMO business, has production bases around the world including Korea, the US, Ireland and France. SK Inc. established a global production network by acquiring an API manufacturing plant (now SK biotek Ireland) in Ireland in 2017 from Bristol-Myers Squibb (BMS), and AMPAC Fine Chemicals, a leading CDMO in the US in 2018. SK Inc. acquired Yposkesi, a French CDMO for cell and gene therapy (CGT), in March 2021 and invested USD 350 million in Center for Breakthrough Medicines (CBM), a US-based CGT CDMO, in March 2022, to become the second largest shareholder.