Developing Scalable, Robust Processes That Result in Stable, Active Products

KBI Biopharma is a leading contract development organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners, including global pharmaceutical and biotechnology companies and organizations in biodefense. Our clients benefit from faster time to market and lower cost of manufactured goods.

Ongoing Innovation

We are continually working on new technologies and new partnership opportunities to enhance biomanufacturing. Our expertise in biophysical and biochemical protein characterization makes us highly successful in delivering optimal product stability and bioactivity for our clients. Biophysical characterization leads to optimized, predictable processes and rugged, effective formulations that allow for rapid approval, lower costs of goods and a decreased regulatory burden. We excel in formulation and analytical development and have positioned ourselves to expand our capabilities in other areas of biopharmaceutical product development such as process development, clinical manufacture (including fill/finish), and GMP release and stability testing.

Technical Differentiation

Scientific Expertise

our scientists have extensive expertise in the development of proteins, peptides, antibodies, vaccines, and small molecules. Our staff uses their specialized understanding of biopharmaceutical and pharmaceutical development and commercialization to deliver a high-quality technical package to our customers. Our scientific, quality, and regulatory staff possesses the experience — proven through numerous IND and NDA submissions — to meet the challenges that arise at all stages of drug development. The advantages we offer our customers stem from our knowledge of the key issues they face: the need to develop and commercialize biopharmaceuticals that will dramatically improve the quality of life in the 21st century — products that have to get to patients as quickly as possible while proving to be economically viable. By clearly defining the design space possibilities associated with a particular compound, our clients gain a road-map of opportunities for future growth.

Comprehensive Services

Our service offerings can take you from clone selection through supply of clinical trial material — which gives you control and predictability in planning and budgeting, faster time to the clinic, and seamless technology transfer to large-scale manufacturing.

Proven Processes

We provide our services using robust internal processes and quality systems that ensure you receive a quality technical package that meets or exceeds your expectations.

Extensive Facilities

Our qualified laboratories are CGMP-compliant and equipped with state-of-the-art technology to ensure rapid and accurate product characterization and method development. Our spacious facilities provide additional avenues for collaboration.

Client Commitment

When you choose KBI Biopharma as your drug development partner, you can expect individualized attention, excellent communication, and ongoing collaboration with a study director and senior scientists working on your project. The drug development process is long, expensive, and filled with twists and turns. At KBI Biopharma, we offer services that enable you to steer your way through critical stages in the process — productively, efficiently, and with the greatest opportunity for long-term success. We recognize the incredible investment you have already made to bring your compounds to this point. We structure your project specifically to take the output of your work to the next level. And we make it our goal to become a seamless and responsive extension of your own organization.