KBI Biopharma

KBI Biopharma, a JSR Life Sciences company, is a global Contract Development and Manufacturing Organization (CDMO) specializing in developing and manufacturing biopharmaceuticals. Established in 1996, KBI offers comprehensive services designed to accelerate the drug development process for pharmaceutical and biotechnology companies worldwide.

Services Offered

• Cell Line Development: KBI provides mammalian and microbial cell line development services, ensuring efficient and scalable production of biologics.
• Process Development: Focuses on creating robust, reproducible, and scalable processes for new biologics, facilitating smooth transition from development to manufacturing.
• Analytical Development: Offers comprehensive analytical services at every phase of the project cycle, addressing complex challenges in biologics.
• Formulation Development: Utilizes a data-driven approach to develop optimized formulations enhancing stability and efficacy of therapeutic proteins.
• Characterization: Provides extensive characterization services to deepen understanding of molecules, ensuring quality and consistency.
• Clinical Manufacturing: Offers clinical biologics manufacturing services adhering to current Good Manufacturing Practice (cGMP) standards.
• Commercial Manufacturing: Delivers reliable GMP manufacturing services for commercial supply of biotherapeutics, ensuring scalability and compliance.

Innovative Platforms

• SUREtechnology Platform™: Powered by Selexis®, this platform offers premium, stable, and integrated Chinese Hamster Ovary (CHO)-based cell line development characterized by versatility, scalability, and efficiency.
• PUREplatform™: A new standard in E. coli expression providing clean and efficient therapeutic protein production, emphasizing increased efficiencies, exceptional quality, and suitability for commercial use.

Global Presence

KBI Biopharma operates multiple facilities across the United States and Europe, including:

• Durham, NC, USA
• Research Triangle Park, North Carolina
• Boulder, Colorado
• Louisville, Colorado
• The Woodlands, Texas
• Geneva, Switzerland
• Leuven, Belgium

Strategic Alliance

In January 2024, KBI Biopharma formed a strategic alliance with Argonaut Manufacturing Services, Inc. to offer integrated drug substance and drug product manufacturing solutions.

This collaboration aims to provide biopharmaceutical clients with end-to-end services, combining KBI's drug development and biologics manufacturing expertise with Argonaut's sterile fill-finish capabilities.

Commitment to Excellence

KBI Biopharma's dedication to quality, innovation, and customer-focused solutions has established it as a trusted partner for biopharmaceutical companies worldwide.

The company supports the advancement of drug candidates from preclinical stages to commercial production, ensuring reliable and scalable manufacturing solutions.