KOLON BIOTECH

KOLON BIOTECH Contract Manufacturing & Development (CDMO) Profile

Kolon Biotech: Your Trusted Partner in Biopharmaceutical Manufacturing

Kolon Biotech, a subsidiary of the renowned KOLON group, is a leader in Cell and Gene Therapy CDMO services, offering over 20 years of expertise in the biopharmaceutical industry. The KOLON group is one of South Korea’s top conglomerates, involved in sectors such as construction, key materials, fashion, energy, and Bio & Healthcare.

Our rich legacy and vast experience make us a reliable partner for companies looking to innovate and scale up their biopharmaceutical projects. Kolon Biotech has a strong track record of manufacturing and supplying commercial products in South Korea. We are actively expanding our market presence in the USA, Japan, and Europe, honing in on advanced scaling-up technologies to better serve our clients.

Why Choose Kolon Biotech?

1. Proven Expertise and Global Reach : With a history of pioneering advancements and over two decades of experience in the Bio field, Kolon Biotech stands out as a leader in Cell and Gene Therapy CDMO. Our strategic partnerships with global leaders and robust quality systems ensure adherence to international regulatory standards such as ICH, PIC/S, and WHO.

2.Comprehensive End-to-End Services : We provide a full spectrum of services encompassing Cell banking, Process Development, GMP Manufacturing, Quality Tests, CMC Documentation, and Storage. Our approach enables seamless progression from clinical trials to commercial production, ensuring consistency and reliability throughout the product lifecycle.

3.Innovative Technological Solutions : Our advanced 2D automated manufacturing technology minimizes contamination risks and ensures batch comparability and reduced process durations. We are also pioneering 3D adherent cell culture technology, enhancing our capability to tackle complex and novel biopharmaceutical projects.

4.Strategic Facilities and Scalable Processes : Our bio plants in Chung-ju, South Korea, are designed to meet diverse client needs. Bio Plant 1 caters to early commercial stages, while Bio Plant 2, equipped with advanced automation, focuses on global mass production, ready to comply with cGMP and JGMP standards by 2027.

We offer flexible production slots and set scalable processes from the early stages, ensuring that your late-stage scale-up is smooth and efficient.

5.Quality and Compliance : Our operations are underpinned by a robust quality system compliant with global standards. We offer in-house QC Tests and can develop custom analytical methods to meet your specific requirements.

Partner with Us

Choosing Kolon Biotech means partnering with a company that combines deep industry expertise, state-of-the-art facilities, and innovative technologies to deliver reliable and scalable biopharmaceutical manufacturing solutions. Our commitment to quality, global compliance, and client-centric services ensures that your R&D and production goals are met efficiently.

Reach out to us today to explore how Kolon Biotech can support your biopharmaceutical manufacturing needs and drive your projects to success.

CDMO Services:
Cell & Gene Therapy Liquids; Lyophilized amps/vials; Sterile Vials Analytical Development; Drug Delivery System; Formulation Development; ICH Stability Testing; Process Development Live Biotherapeutic Products

Year Founded: 1990

Head Office: Seoul,

Number of Facilities: 1-2

Facility locations: East Asia

Website: Visit the KOLON BIOTECH website

Linkedin: Connect on Linkedin

Current Capacity: We have reserved Future areas in our existing facilities and possess additional land for expansion. In Cell and Gene Therapy, we are open to all investment and business opportunities, ready to discuss potential partnerships.