Clinical Manufacturing

Engineering New Biologics, At Scale

Making Complex Applications Possible with Mammalian-Based and Microbial-Based Expression for New Biologics

 

KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical and clinical supply.

KBI’s experienced team produces high-quality therapeutics and vaccines through processes developed in-house or through processes transferred in from our clients.

Our state-of-the-art manufacturing facilities meet global regulatory requirements and employ the latest disposable production technologies, allowing maximum flexibility and short turn-around times.

Our clinical manufacturing services include:

• Clinical Mammalian
• Clinical Microbial
• Clinical Release & Stability

Our cell culture and microbial manufacturing facilities are fully separated, including independency for specific utility systems serving only their assigned production areas. Multiple HVAC zones, unidirectional flow of personnel and materials, and strict environmental monitoring schema ensure the highest environmental quality for your clinical manufacturing process.

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