KBI Biopharma
KBI Biopharma
Understanding what you need. And delivering it exceedingly well.
The advantages that 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.
With our unique expertise in biophysical characterization, and our extensive analytical expertise, KBI Biopharma can provide clients with a depth and breadth of product understanding that simply cannot be replicated anywhere else.
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.
By clearly defining the design space possibilities associated with a particular compound, our clients gain a roadmap 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 for our clients.
Scientific Expertise
Our scientists have extensive expertise in the development of proteins, peptides, antibodies, vaccines and small molecules. Our staff utilizes their specialized understanding of biopharmaceutical and pharmaceutical development and commercialization to deliver a high-quality technical package to our customers.
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, and our spacious facilities provides additional avenues for collaboration.
Ongoing Innovation
We are continually working on new technologies and new partnership opportunities to enhance biomanufacturing. Our proprietary Centrifugal BioReactor technology is just one example of how we are helping to move the industry forward.
Client Commitment
When you choose KBI Biopharma as your drug development partner, you can expect individualized attention, excellent communication and ongoing collaboration with the study director and senior scientists working on your project.
Finished product solutions driven by formulation expertise.
KBI Biopharma is expanding our cGMP clinical manufacturing facilities with state-of-the art equipment to include aseptic filling and lyophilization of Phase I and II clinical supplies. With the launch of these services we will provide seamless development of a variety of biopharmaceutical dosage forms, starting from preformulation to a finished product.
Our experienced Quality Assurance and Regulatory staff oversees the entire clinical manufacturing process and provides consulting for our as clients as needed.
Liquid Filling
Wide range of vial sizes ranging from 1mL to 100mL
Coated or standard 13-mm, 20-mm and 28-mm stopper configurations
Automated or Semi-automated filling equipment
Flip-off or tear-away seals
Lyophilization
Steam sterilizable lyophilizer accommodates 5,000 - 20,000 vials of 20mL and 1mL vials respectively
Fully capable of scaling-up lyophilization cycles developed at KBI or elsewhere.
PO Box 15579
Durham, NC 27704
(919) 479-9898
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