Search results for " raw materials"

Article Ensuring the Biological Integrity of Raw Materials
Although contamination can occur from the cell culture itself or from labware and the laboratory environment, raw materials are the most significant source of contamination, which can lead to false re…

Article Raw Material Variability
It would seem that raw materials used in bioprocessing operations are a relatively straightforward factor given the overall complexity of commercial manufacturing. In fact, they give a surprisingly di…

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The two raw materials only differ in that resin B has a higher PE molecular weight and comonomer level. Figure 3 summarizes the results of tracking TBPP-related species in samples from the entire …

Article Managing Risk in Raw Material Sourcing
“Plant-of-origin information and transparency regarding the source of raw materials is essential for traceability,” he says. Avantor has globalized and standardized quality systems at its faciliti…

Webcast 5 Questions to Ask Before Selecting a Raw Materials Supplier
Join us for a free webinar where we will share lessons learned from our experience with raw materials management during the past five decades in bioprocessing.

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
May be used during processing, in raw materials, or in final products, especially multiple dosage medicines.  baculovirus A virus that replicates only in the cells of Lepidopteran insects; it has …

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Other raw materials used in the manufacture of biotherapeutics, especially those of animal and human origin, could also present a viral safety risk. Traditionally, the management of inadvertent vi…

Article Application of Quality by Design to Viral Safety
Using this approach, products are developed with a thorough understanding of how the raw materials and manufacturing processes impact the eventual clinical performance of the final drug product. QbD f…

Article Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
…ch as bovine sources, and also to require stringent testing and justification for any animal-sourced raw materials used in producing biopharmaceuticals, even for materials that are not associated wit…

Article Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical manufacturers’ change-control systems are designed to ensure that any changes to raw materials, product contact materials, manufacturing methods, product tests, and production equipment…

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