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.
Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.
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.
For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.
Biopharma executives must consider how outsourcing fits into their development and production strategy. Here’s a step-by-step guide to help make that decision.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.
There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
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