From a vision to a vial in 12 months - Process development and cGMP manufacture for Cleveland BioLabs Inc (CBLI) by SynCo Bio Pa

Posted: 05/11/2008

In September 2006, Cleveland BioLabs Inc. approached SynCo with a challenge – could they help to develop a production process, scale up, and manufacture a cGMP batch of their recombinant protein treatment for exposure to radiation (Protectan CBLB502) in approximately a year? Normally, developing a new production process and scaling up from 5L to 1500L to produce a cGMP batch suitable for Phase I clinical trials, including filling, can easily take 18 to 24 months.

SynCo accepted the challenge and, as a result of truly diverse thinking, excellent communication and teamwork between CBLI’s consultants and its staff, plus sheer smart work and a ‘can do’ attitude, SynCo was able to deliver filled final drug product suitable for Phase I clinical trial use in October 2007, 13 months after the start of the project. There were definitely times when the deadline was in jeopardy, but innovative problem solving in close collaboration with CBLI and its consultants got the project back on track.

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