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.
Critical quality attributes (CQA) are fundamental to regulatory compliance and typically include data on how the candidate interacts with target proteins, size, and purity. In addition, information on process related CQA such as protein integrity, homogeneity, presence of host cell proteins, and DNA is required. This poster booklet provides a snapshot on how different analytical technologies have been used to look into aspects related to the efficacy, stability, and safety of therapeutic candidates.
Working within a high-intensity environment, any strategy to simplify workflows can both relieve pressure on analysts and support data quality, improving lab efficiency and throughput.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
Discover how new smart valve technology can automate your pneumatic energy savings, tamper proof your equipment settings, and enable flexible automation.
A guide selecting the most relevant environmental parameters to study to retrieve the most useful information from collected samples.
This e-Book provides an illustration of the cutting-edge presentations from BioProcessing Asia 2018, from the sustainability of biosimilars, to the regulatory climate in Asia, the challenges facing the international bioprocessing community and the latest technologies for viral vector/vaccine production.
This application note describes a process for adenovirus production, from upstream cell culture to downstream purification, using modern tools and technologies.
This article explains how maximizing the effectiveness of CO2 and yeast removal will assist in improving accuracy in total acidity measurements at every stage of the brewing process.
Need to find out how to calibrate your size exclusion chromatography (SEC) column? Or how different additives affect your results? Read these useful insights.
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