An overview of the tools and technologies available for development of viral vectors and to provide insights into techniques that viral vector manufacturers can use to intensify their production processes.
The pharmaceutical landscape continues to evolve, with much R&D focusing on more specialized medicines. As the biological activity and specificity of the API increases, dosage strengths decrease – resulting in increased potency of the APIs in terms of occupational handling for drug product manufacture. This paper examines the process of successful high potency drug manufacturing and delivery to market.
Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.
Highly potent active pharmaceutical ingredients (HPAPIs) represent an increasing fraction of new compounds in pharmaceutical pipelines today. Flexible and phase-appropriate infrastructure is needed to bring the next innovative medicines based on these challenging compounds from concept to commercialization. Thispresentation describes Lonza's HPAPI "manufacturing 4.0" investments and the company's innovative capabilities.
Gaining a better understanding of continuous manufacturing and its fitness for your OSD product could secure more control over the quality and safety of your product and, ultimately, the future of its success.
While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?
The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.