Emerging Trends in Sterile Fill and Finish Technology
New packaging materials, disposable devices and automated systems offer enhanced performance. The core goals of an aseptic fill and finish process have remained essentially the same for more than two decades. Manufacturers of sterile drugs seek to maintain uncontaminated conditions throughout the packaging process, performing the filling and finishing stages [...]
Prefilled Syringe Manufacturing for Biopharmaceuticals
Regulations in this sector are rapidly tightening, but advances in materials and manufacturing techniques can help manufacturers meet rising expectations. As biopharmaceutical formulations capture ever-greater market share, demand for self-administered delivery systems has fueled rapid advances in the manufacturing of prefilled syringes. With increasing volume have come innovations in packaging [...]
3 Challenging Complexities of Preclinical Toxicology Studies
Before a drug can proceed to the clinical trial stage, its developer must first pinpoint its likelihood of harming people by performing in vitro and in vivo toxicological studies. These studies involve a number of technical complexities, of which the following three are particularly challenging: 1. In vitro toxicology [...]
7 Critical Reasons to Invest in Pharmaceutical Analytical Services
Manufacturing competencies aren't the only reasons to partner with a contract manufacturing organization (CMO). Throughout every stage of your pharma development process, analytics can help increase efficiency, raise margins, and keep you ahead of your competition in all seven of the following ways: 1. Validation programs characterize useful compounds, [...]
5 Major Benefits of Vero Vaccine Development Pipelines
Rapid virus evolution challenges the medical industry with new strains every year. The Vero cell platform meets these challenges with a streamlined system for the rapid development of novel vaccines. The platform has proven effective at developing vaccines for SARS, avian influenza and other evolving threats, for the following [...]
Blow-Fill-Seal
This innovative process mitigates risks associated with the sterile biologics manufacturing. However, tight control of parameters is critical. The risk of contamination is always present throughout any pharmaceutical manufacturing pipeline. That risk is particularly acute in biologics fill and finish. For that reason, a growing number of biologic manufacturers are [...]