Immunogenicity, defined as the ability of a substance to produce an immune response, is key to a successful and safe biopharmaceutical drug development program. Therapeutic Antibodies, enzyme therapies, peptides and […]

According to the ISO standard 10993, a medical device should be biocompatible i.e. not induce any adverse effects when it comes in contact with the patient. The standard provides a […]

Pharmacokinetic (PK) and Toxicokinetic (TK) analysis is an important aspect of drug development.  These studies may be exploratory in nature or more extensive and formal.  Understanding the bioavailability, exposure, half-life, […]

Last week I was privileged to be able to participate in a focus group for California East Bay biomanufacturing.The purpose of the focus group was to generate […]

Medical Device biocompatibility, once considered just a "box-checking" activity, continues to become more complex. This was the focus of a talk at the 2012 American College of Toxicology Annual Meeting […]

This year has been somewhat up and down for medical device developers. The medical device excise tax was approved, and any devices sold starting in 2013 will be subject to […]

Have you ever wondered what the difference is between the different types of botulinum toxin? There are seven distinct variations of the neurotoxin, botulinum toxin, which is produced by the bacteria, […]

As part of their effort to provide clearer directions for industry, the FDA recently published a new guidance document for ICH Q8, Q9, and Q10.This document is taken […]

Increasingly, device makers are discovering what pharmaceutical companies have known for many years – that using CROs to support regulatory testing can speed up development efforts and, ultimately, save money. The […]

Demand in the market for quality textiles that meet consumers’ demands for comfort and freshness has been increasing.  Antibacterial performance depends on its ability to inhibit the growth of bacteria.  […]