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 [...]
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 [...]
Improvements throughout the pipeline bring greater biologic yields, as well as higher quality. by Raymond E Peck, CEO of VxP Biologics Improvements throughout the pipeline bring greater biologic yields, as well as lower costs. Bioprocessing is the production of natural or genetically manipulated cells (or other organic parts). In the field of biologic pharmaceuticals, bioprocessing [...]
The creation, production and storage of viral vectors all pose highly unusual challenges. by Susan Thompson, Technical Director at VxP Biologics Traditional viral vaccines use attenuated or inactivated forms of viruses to trigger and “train” the body’s immune responses. In recent years, however, pharmaceutical developers have also begun to use viruses as vectors to deliver [...]
Advances in Biological Safety Level 3 technology offer advantages for agile biologic developers. by Raymond E Peck, CEO of VxP Biologics Many types of biologics include live populations of organisms, some of which may be highly infectious in active form. Vaccines, in particular, often contain deadly bacteria and viruses in live but attenuated forms. The [...]
As the biologics market expands, developers need support from expert contractors. by Raymond E Peck, CEO of VxP Biologics A growing number of pharmaceutical development companies are partnering with contract manufacturing organizations (CMOs) to meet the global demand for biologics. This investment comes with good reason: as of 2016, the global biopharmaceutical market was valued [...]
