SAFC completes protein purification capacity expansion
announced it has completed the construction of two protein active
pharmaceutical ingredient (API) facilities at its US manufacturing
site.
The company invested $16m (€12m) in the expansion in order to meet increased market demand for therapeutic proteins derived from plant- and animal-sourced materials. The new operations, located at the company's Missouri manufacturing campus, feature two separate facilities in order to eliminate potential cross-contamination, SAFC said. A new 25,000 sq. ft biologics manufacturing facility with a purification and manufacturing suite will be dedicated to transgenic plant and non-animal derived protein APIs while animal-derived protein purification will be conducted in a separate 6,000 sq. ft facility, the company said. SAFC claims the biologics facility features some of the largest extraction and purification suites of their kind in the industry. The Class 100,000 (ISO 8) and Class 10,000 (ISO 7) clean rooms will accommodate multiple one-meter chromatography columns and ultrafiltration operations, with API target quantities in the 5 kg range. Also featured is a Class 10,000 (ISO 7) lyophilization suite. Meanwhile, the facility for animal-derived API purification also features similar clean rooms. These will also include multiple one-meter chromatography columns and ultrafiltration operations to give API quantities in the five-kilogram range. Validation for commercial operation of the expansion at the 400,000 sq. ft. St Louis manufacturing site is expected by mid-year 2007. "The expanded capacity responds to the increased demand for large-scale supply and will meet late-stage clinical trial and commercial manufacturing needs for both transgenic and naturally-sourced APIs," said SAFC President Frank Wicks. The company said it had several projects moving into late-stage clinical trials and commercial manufacturing and decided to expand to meet higher demand from customers.
