The Alachua contract manufacturing organization (CMO), which makes biopharmaceuticals for Phase I and II clinical trials, installed a 400L disposable bioreactor at its production plant and a 10L culture vessel at its process development laboratory.
The firm has also increased its class aseptic filling capacity by 70 per cent, enabling its class 1000 fill suite to fill batches of 5,000 vials for containers in the 0.1ml to 3L size range.
In a press statement, Synder said the investment “underscores [Florida Biologix’] commitment to continue to meet the needs of our clients who appreciate how we are able to find cost-effective solutions for their clinical projects, overcome difficult technical challenges and deliver released products on-time”.
He added that: “We believe that the best way to build long-term relationships with our clients is through frequent, open communication, delivering on-time and providing clients full ownership of their manufacturing process.“
Spokesperson Chris Aytug told Outsourcing-pharma that demand for larger capacity had been a key motivation for the expansion, explaining that the firm’s deal with America Stem Cell had “played a role in the decision, but was not the only factor. They will be utilizing the capacity along with others.”
Aytug went on to speak about recovering demand for this type of contract manufacturing work in the clinical trials sector, after the industry-wide drop that has accompanied the economic downturn over the last 18 months.
"Inquiries and contracts dipped in late 2008 and the first half of 2009, but then picked up dramatically for us in the second half of the year. Activity this year seems to be picking up again, but time will tell."