eBook: Raw Materials Quality, Processing, and Storage — A Manufacturing Case Study

Raw material storage, handling, and processing are essential to ensure high product quality and consistent process performance. Slight variabilities in raw materials (either inherent in the material or through processing) can compromise yield and even result in batch loss. On Tuesday 26 September 2017 speakers at the BioProcess International Conference (part of Biotech Week Boston) addressed raw material variability and control strategies in biomanufacturing. They discussed the industry’s initiative for raw material risk assessments and strategies to control variability by defining trace metal and carbohydrate composition in upstream process development. That afternoon, Bunyada Vamnutjinda Kwong, senior engineer of manufacturing sciences, cell culture, at Genentech (Vacaville, CA) presented a manufacturing case study in raw material and storage conditions. Her presentation focused on the current landscape of raw materials, cell culture process flow, the importance of raw materials for cell culture, internal requirements of raw-material handling, and an overview of a case study of how raw material had affected process performance and product quality.

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