Regulatory approval of a biosimilar requires comprehensive knowledge of both the process and the molecule while process development with the end goal in mind will help to achieve a robust manufacturing process.
In the lifecycle of pharmaceutical and biopharmaceutical commercial manufacturing, the one constant has been change. With the advent of modern therapeutics, large scale commercial manufacturing became common place.
The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
Additional applications of PVA for sustained release and solubility enhancement that address specific challenges in pharmaceutical formulations.
Successful qualification and documentation processes start in the planning phase of a project, follow through manufacturing and lifecycle of the equipment.
How an integrated development platform can provide end-to-end visibility across pre-formulations and formulations development.
How to overcome the challenges the shift from internal to external, or virtual, R&D teams poses.
A solution designed to provide a working environment that is easy to use across multiple disciplines to meet the full range of scientific needs.
A lack of consistency in the capture, management and analysis of data is a barrier to both collaboration and understanding, and hampers the development of novel products and processes.
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