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 [...]
