KBI Biopharma is a leading contract development and manufacturing organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners.
Our Core Facilities include:
*Mass Spec Core Facility: KBI’s state-of-the-art mass spectrometry core facility delivers unparalleled structural characterization services to our clients.
*Particle Characterization Core Facility: KBI’s Particle Characterization Core Facility provides specialized, state-of-the-art analysis for subvisible particles ranging in size from nanometer to micron.
Our core capabilities include:
*Cell Line Development;
*Process Development;
*Analytical Development;
*Qualification, Validation;
*Biophysical Characterization;
*Formulation Development;
*Mammalian cGMP Manufacturing;
*Microbial cGMP Manufacturing;
*GMP Release and Stability.
*Cell Therapy
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.