DNA sequence-based technology aims to meet FDA aseptic processing requirements

05/01/2005

BY STEVE SMITH

FOSTER CITY, CA-An established DNA sequence-based technology developed by Applied Biosystems Corp. (www.appliedbiosystems.com) is now being touted for helping pharmaceutical makers meet recent FDA aseptic processing requirements for the manufacture of sterile drug and biological products.

At the annual meeting of the International Association for Pharmaceutical and Biopharmaceutical Science and Technology (PDA; www.pda.org), held in early April in Chicago, Applied Biosystems President Catherine Burzik announced that the company’s established MicroSeq Microbial Identification System will help pharmaceutical makers more accurately document sterility control per new FDA requirements while rapidly identifying microbial hazards.

The MicroSeq technology, says Burzik, “provides manufacturers a quality control tool to help them rapidly identify unknown organisms and mitigate the risks associated with production downtime and lot quarantine.”

Applied Biosystems claims that its MicroSeq technology is the first DNA sequence-based system to provide advanced identification of sterility isolates to the species level. Key to the technology is the system’s in vitro polymerase chain reaction (PCR)-based sequencing methods that amplify and rapidly identify organisms and DNA regions of interest. These sequences are then compared to a validated library for positive identification and taxonomic classifications. Methods are based on the DNA sequence of the 16S ribosomal RNA gene-believed to be an objective basis for bacterial taxonomic classification.

The MicroSeq system, already in use by clinical labs, environmental monitoring agencies, and pharmaceutical and vaccine manufacturers, is designed for developing properly documented manufacturing quality controls that can help quickly identify and solve sterility failures. While some methods for identifying bacteria or fungi can take several days before results are learned, the MicroSeq system claims same-day results that are reproducible from lab to lab.

The system features sample preparation reagents and protocols, bacterial and fungal application kits, analysis software designed for FDA 21CFR Part 11 compliance, validated libraries of bacterial and fungal ribosomal DNA sequences, and thermal cycling and sequencing systems.

According to the company, a basic workflow of four steps-sample prep, DNA amplification, cycle sequencing, and analysis and identification-is designed to be performed by bench scientists who may have little previous molecular biology experience.

“Properly documented sterility control is critical for all of our customers, especially those in pharmaceutical manufacturing,” says Mark Stevenson, division president/applied markets. “Not only do customers need products that speed up the manufacturing process, but they also need tools that will assist them to meet strict best practice guidelines for quality control and accuracy.” III