Testing

Genalyte, Inc. today announced the launch of its MT-ADA anti-drug antibody (ADA) immunogenicity assay designed to run on the Maverick Detection System.  This test combines screening for the presence of ADAs and the characterization of each detected ADA with a full isotype profile.  With minimal required sample preparation and its combination of detection and characterization in a single assay, the MT-ADA assay streamlines ADA testing for both mouse and human samples, providing real-time detection without the use of dyes, fluorescent probes or radioactive labels.

Genalyte, Inc. today announced the launch of its MT-ADA anti-drug antibody (ADA) immunogenicity assay designed to run on the Maverick Detection System.  This test combines screening for the presence of ADAs and the characterization of each detected ADA with a full isotype profile.  With minimal required sample preparation and its combination of detection and characterization in a single assay, the MT-ADA assay streamlines ADA testing for both mouse and human samples, providing real-time detection without the use of dyes, fluorescent probes or radioactive labels.

UL (Underwriters Laboratories), a world leader in advancing safety, announced today the expansion of the South Bend, Indiana analytical laboratory to offer non-clinical testing services for the medical device industry.

UL (Underwriters Laboratories), a world leader in advancing safety, announced today the expansion of the South Bend, Indiana analytical laboratory to offer non-clinical testing services for the medical device industry.

In May, the U.S. Pharmacopeia will host a workshop, “Pharmaceutical Packaging: Moisture Permeation.” One of the main functions of the workshop will be to discuss proposed new revisions to General Chapter <671> Containers—Performance Testing that will be included in Pharmacopeial Forum 39(2 ) March-April 2013.

By Hugh G. Willett
Technology Journalist

Developing a new drug-delivery device requires detailed knowledge about all components as well as device performance in different situations. Medical device development companies are using advanced characterization and testing of materials at the product development stage to ensure quality in design and high-volume manufacturing.

Today Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche's biological products. It is the first commercially available mycoplasma PCR test accepted by the FDA for release testing of a biopharmaceutical product that can replace conventional and time-consuming mycoplasma detection assays based on culture methods.

The US Drug Watchdog says, "There are about 500,000 US recipients of a metal on metal hip implant, and unfortunately some European health agencies are suggesting failure rates of 50% with all metal hip implants.

A new white paper is available to assist medical device manufacturers with understanding recent changes to the U.S. Food and Drug Administration's (FDA) thinking regarding endotoxin testing. The paper is available to download from the Web here. .