SAFC Pharma extends its assay development capabilities

SAFC Pharma, a division of the US Sigma-Aldrich group, has begun operations at its new 7,000sq ft laboratory complex in Carlsbad, California.

Located next to the company's flagship viral substance production facility, the new laboratories support SAFC Pharma's biologics offering for the pharma and biotechnology markets and complement its biologics capabilities through process improvement, technology transfers of processes and assays, and characterisation of active ingredients.

The new complex includes a dedicated polymerase chain reaction (PCR) facility, a tissue culture laboratory and stability suite supported by microbiology and regular testing labs. It houses a scientific team focused on quality control (QC), process development, assay development and validation.

The new PCR facility consists of separate suites with uni-directional personnel flow for sample processing, reaction assembly and PCR amplification.

In addition to PCR assays, the unit is capable of performing cell-based, molecular and immunological assays, as well as analytical assays such as HPLC. All suites are equipped for independent air handling with air pressure gradients to prevent cross-contamination.

On-site QC functions will include environmental monitoring and microbiology, stability, product and raw materials release, plus analysis of in-process samples using advanced instrumentation. All standard operating procedures and protocols to be carried out in the laboratories are designed to follow cGMP guidelines.

Commissioning of the new laboratories at Carlsbad follows SAFC's 2008 announcement of a US$12m expansion at the site to construct two fully segregated manufacturing suites. Due to be operational before the end of the year, these suites will add an additional 8,000sq ft of manufacturing space and enable 100-litre batch production in stirred tank bioreactors and 500-1,000-litre batch manufacturing in disposable bioreactors. The expansion will add commercial manufacturing capacity within the current 44,000sq ft site and is planned to be Biosafety Level 2 compliant, allowing manipulation of human pathogens.