Search results for " specification"

Article Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins. By Adeline Siew, PhD  CA-SSIS/shutterstock.comIm…

Article Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success. By Cynthia A. Challener Next-generation antibodies are designed to be more specific and are ofte…

Article Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs. By Cynthia A. Challener Bioreactor design, including the geometry of the tank and impeller and the locati…

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Review of critical raw material specifications for adequacy and viral safety acceptance criteria. • Maintain a detailed supplier auditing and qualification program that includes biosafet…

Article Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination. By Randi Hernandez There are multiple variables to consider …

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

Article Robust Optimization, Simulation, and Effective Design Space
Using an enhanced approach, the determination of appropriate material specifications and process parameter ranges could follow a sequence such as the one shown below: • Identify potential sources …

Article Host-Cell Protein Measurement and Control
Results from batch to batch should be consistent and meet specification limits” (8). Regulatory agencies from other countries and emerging markets may have their own wording on HCP control, but it…

Article Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …

Article Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…

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