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 in a cleanroom, using only [...]
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 and storage methods, and novel [...]
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 studies provide only limited insight [...]
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, streamlining the selection of stable [...]
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 five reasons: 1. Rigorously validated [...]
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 turning to novel aseptic (sterile) [...]
The field has advanced considerably in recent years, but a number of key challenges remain. by Raymond E Peck, CEO of VxP Biologics Because injectable biologics are introduced directly into the body’s tissues, these formulations must be extraordinarily free from contamination of every kind. This requirement sets a high bar for the manufacturing of injectables. [...]
The correct choice of sterilized packaging is crucial, as is regulatory compliance. by Raymond E Peck, CEO of VxP Biologics While the potency and efficacy of active pharmaceutical ingredients (APIs) remain crucial in biologics manufacturing, the packaging of those drugs is equally critical in ensuring safety and stability. A wide variety of packaging types abound [...]
This powerful technique enables rapid identification and sorting of cells, streamlining the manufacture of many biologic pharmaceuticals. by Raymond E Peck, CEO of VxP Biologics In the manufacture of many types of biologics, flow cytometry is a crucial tool for identifying, analyzing and sorting cells. This technique can provide a wide range of data points [...]
To help accelerate MCM development, VxP Biologics has developed its Advanced Development and Manufacturing of Antibody Technologies (ADAMANT) platform. This platform integrates cell libraries, region design and selection techniques, and formulation standards into a high-throughput production format. By optimizing and standardizing antibody design and production, ADAMANT helps biologic developers bring new antibody candidates to the clinical trial stage more rapidly.
