Ferdinand Dabu, Global Marketing Director, told us at the American Association of Pharmaceutical Scientists’ annual conference that the company is looking “to stay ahead” and there’s “more innovation coming.”
Most recently the company announced that its analytical laboratory in Livorno, Italy was cGMP accredited. The 1085m² laboratory employs 25 staff and is also ISO 9001 accredited. The accreditation enables the lab to demonstrate, on behalf of it clients, whether or not individual batches of their raw materials, or of their regulated product, are manufactured according to the highest quality standards.
Prior to the accreditation, SGS completed work on its fifth North American service laboratory in Carson, California. The 8,000 sq. ft. GMP/GLP facility houses 6,000 square feet of dedicated laboratory space and 2,000 square feet of offices, conference rooms, and client records.
The laboratory, opened Oct. 23, provides microbiological testing and bioanalytical services and initially employed seven scientific staff, with room for expansion in relation to customer demand.
Prior to the opening of the Carson facility, the company also expanded it sfacility in Glasgow, UK, for the testing of cell banks for vaccines, gene and cell therapies, monoclonal antibodies and other recombinant protein based biological medicines. The new laboratory adds an additional 500 m² and will be adjacent to SGS’ existing centre of excellence for viral safety, now totalling 1,124 m², with the enhanced capacity and capability in cell culture testing.
Employing over 45 scientific and quality personnel, the lab will offer a range of validated bioanalytical methods to support the manufacturing, biopharmaceutical stability and lot release of drug product, including host cell protein, endotoxin, ELISA, western blotting and residual impurity testing.
“Customers demand that facilities are up to date and evolving,” Dabu said.
In addition to the Glasgow investment, the company also invested in the French market, with a new facility in Villeneuve la Garenne. The new location, which will replace an existing laboratory in Clichy, is approximately 5km away, and complements the company’s strategy to increase its Quality Control service throughput and support an ever-expanding research and development pipeline of new biopharmaceutical drugs. The new laboratory will be completed in Q2 2015.
The 2000 m2 site is split over two floors, compared to the five floors at the previous site, and each is dedicated to a specific function. The services currently offered at Clichy, including analytical chemistry, microbiological analysis, stability studies and method development services, will be transferred to the new site, along with additional services for biopharmaceutical analysis, including amino acid analysis and mycoplasma testing.
Dabu told us that new instrumentation has been a significant capital expenditure.
Investment at the French site will also be made to increase the number of contained hoods to safely handle biological entities, as well as walk-in stability testing chambers for small molecules.