Kalon Biotherapeutics, now FUJIFILM Diosynth Biotechnologies Texas, LLC
Kalon Biotherapeutics was founded as a biologics development and manufacturing service provider in College Station, Texas.
In December 2014, Kalon joined FUJIFILM Diosynth Biotechnologies, adding its viral and cell culture vaccine capabilities to the comprehensive microbial, mammalian, and insect cell development, analytics, and commercial production expertise of FUJIFILM Diosynth Biotechnologies.
The company’s modern development centers in Texas apply the most advanced single-use technology, containment, and process systems for accelerating all stages of product development and scale-up.
Drug Development Project Management
Kalon Biotherapeutics utilizes a proven and active communicative approach to managing all aspects of preclinical through Phase III clinical manufacturing. Its project management systems allow for an open communication philosophy to accelerate the drug development process at every stage.
Kalon’s experienced project management teams help to set project goals, objectives, and deliverables to help achieve success in accelerating drug development.
National Center for Therapeutics Manufacturing
Kalon Biotherapeutics operates the National Center for Therapeutics Manufacturing (NCTM), offering flexible manufacturing environments and technologies to biological therapeutics. The center includes 110,000 square feet of cGMP space, and houses over 20 modular clean rooms.
The NCTM’s facilities are state-of-the-art and are ideal for biotherapeutics research, development, workforce training, and GMP manufacturing.
Mobile Clean Rooms
The National Center of Therapeutics Manufacturing’s portable modular cleanroom pods is walk-in biological safety cabinets with flexibility in size to accommodate upstream and downstream bioprocessing activities.
Each modular clean room is used for a unique, biologically distinct technology to eliminate cross-contamination and comply with all regulatory agency standards. These clean room labs offer the flexibility that a drug manufacturer needs to develop drugs at any location.