By Anil Doshi, R.Ph., Ph.D, President, Infinity Pharmaceutical Consulting
Process validation comprises three stages that take place over the life cycle of the pharmaceutical drug product. Stage 1, which will be the focus of this column, is referred to as process design, and encompasses pharmaceutical drug products in early development.
By Michiel Van Speybroeck, Ph.D., R&D Director, Formac Pharmaceuticals
It is estimated that around 70% to 90% of new chemical entities in discovery pipelines, and 40% of drugs on the market, are poorly soluble in water. Poor aqueous solubility may drastically limit oral bioavailability and ultimately compromise therapeutic outcome. It is becoming increasingly apparent that the adsorption of poorly water soluble drugs on mesoporous silica materials is a very effective way to address this solubility problem.
By Chris MacKinnon, Life Science Leader What do we do with the packaging on the products we buy? We throw them away, right? But if you consider past the idea that it's "just recyclable material," it's evident that packaging plays an essential role. When it comes to the pharmaceutical industry in particular, this couldn't be closer to the truth.
By R. Barry Holtz, Ph.D., President, G-Con Manufacturing, LLC, and Dennis Powers, Director, Integrated Solutions North America, Sartorius Stedim North America, Inc. With the age of the blockbuster drug passing, the business model for the biopharmaceutical industry is changing. The personalization of medicine, the emergence of biosimilars and biobetters, and the need to provide vaccines globally are just some of the factors forcing biomanufacturers to rethink how future manufacturing capability will be implemented.
By Rosario Quintero-Vives, Sr. Regulatory And Compliance Specialist, RQV Consulting Disregarding the rules in the regulated industry is like a contagious disease. If you don't control it in the beginning, you and your organization will be lost. In advanced stages, it could require the termination of many employees with this disease. When the FDA recommends you hire fresh eyes for quality systems on a warning letter, it actually means your problem is institutionalized.
By Peter Müller, Ph.D., CARBOGEN AMCIS AG Routine inspections by the U.S. FDA are just as important for non-U.S. pharmaceutical manufacturers as they are for U.S.-based companies. This is especially true for Swiss companies, which export a great share of their products to the United States.
By Lisa Choplo, Miele Professional Hand washing not only presents inherent safety risks for employees, but is also not a repeatable process and produces variable results. Automating the washing process is one step that can be taken to modernize the laboratory and make it a safer and greener work environment.