Search results for " microbial" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
These challenges manifest in quality issues with the final container closure and may be related to microbial contamination, glass particulates, and foreign materials that lead to necessary market acti…
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Modular Manufacturing Platforms for Biologics
Jornitz notes that there has been recent interest in the use of pods for analytical, microbial, polymerase chain reaction, and assay development, as well as interest in the use of pods for broader hea…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
“These stages include formulation composition, presence of microbial or vial contaminants during cell culture, and storage,” notes Olcott. Work by Hasija et al. (2) on forced degradation studies in va…
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Technologies and Practices Must Evolve to Meet Demand
Regulatory issues and microbial contamination, however, were of greater concern for the 2015 survey participants. Producing high enough product yields, purifying high product yields, and protein aggre…
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Improving PAT for Biologics
There has, however, been significant progress in the application of rapid methods for microbial testing and control, as well as the determination of protein concentration, according to Dhanasekharan. …
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Manufacturers Struggle with Breakthrough Drug Development
FDA will want to know how the company will validate manufacturing processes for drug substances and products, will ensure microbial control for sterile drugs, and will handle changes in formulation an…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Key considerations such as LEAN, multipurpose and flexibility was designed and built in to the facility from start, ensuring high capacity, microbial control and tracing of all filled vials. During th…