Steps to ensure products are free from microbial contamination and achieve a sufficient level of risk mitigation against potential bioburden issues for these applications.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
How ADC chemistry and manufacturing have evolved over the years, present the challenges this growth has created and describe how CDMOs are adapting to these changes to meet customer needs.
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.
This paper includes a discussion on vaccine processes, followed by a case study on 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.
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