Upgrading the Fairfield, New Jersey facility to Biosafety Level 2 (BSL-2) rating extends the range of products SGS can work with, and therefore the firm is now able to offer its customers microbiological, chemical and stability testing of such substances as serum, antibodies, and phagocytes.
SGS spokesman Ferdinand Dabu told Outsourcing-Pharma the firm had received “very positive” feedback from its customers to the upgrade, and there is “already a large project that has started, and another one in the pipeline.”
The firm placed the need to upgrade down to an increased demand in biopharma firms involved in developing vaccines against pathogens such as Poliovirus, Rotavirus, Influenza A, and Hepatitis A, B and C.
Dabu was unable to disclose the monetary details of enhancing the facility’s containment capabilities, but the news comes three years after SGS ramped up its testing capacity, adding 15,000sq ft of GMP and GLP space.
According to the Centers for Disease Control and Prevention (CDC) guidelines, a BSL-2 facility requires specific procedures and staff training to ensure safety when working with agents that pose moderate hazards to personnel and the environment.
On top of the standard microbiological practices expected, SGS staff must be provided medical surveillance an demonstrate proficiency in standard and special microbiological practices, while there are more stringent rules on the handling and storing of substances and the decontamination of equipment.
There are four levels of Biosafety, the fourth and most extreme being “required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission,” according to the CDC.