Formatech has added a second GMP lyophilizer, increasing its aseptic fill and finish capacity for lyophilized drug products. The Virtis Benchmark 3000 lyophilizer provides 36 sq. ft. of shelf area and can support production runs of as many as 13,000 vials per campaign. The installation and validation was completed in December 2008.
“Timely access to lyophilization capacity is a growing concern for the biotech and pharmaceutical industries,” said Jeffrey Bernard, director of business development. “This is especially true for companies that are producing clinical supplies. Given the cash burn rate of the typical emerging biotech or pharma company, a delay in production by even a week due to production capacity constraints may cost a client hundreds of thousands of dollars. By doubling our capacity for processing lyophilized products, we have reduced the bottleneck, can better meet our clients scheduling needs and most importantly get them to the clinic on time.”