Search results for "ICH Q6B"

Article Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…

Article Understanding Validation and Technical Transfer, Part 3
ICH Q6B contains comprehensive guidance on setting specifications for biological products (8). The control strategy assessment requires evaluation of the criticality, probability, and detectabi…

Article Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge. By Thomas A. Little, PhD To control the consistency and quality o…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells. By Luhong He, Christopher Frye Abstract …

Article Host-Cell Protein Measurement and Control
Jun 01, 2015 By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem BioPharm International Volume 28, Issue 6, pg 32–38 Host-cell proteins (HCPs) constitute a major part of proce…

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
“This characterization should include the determination of physicochemical and immunochemical properties, biological activity, purity, impurities, and quantity of the mAb, in line with ICH Q6B guideli…

Article Using Multiple Techniques in Biosimilar Analysis
Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation. By Rebecca Strawn  Sergey/stock.adobe.com Almost all drug product…

Article Impurity Testing of Biologic Drug Products
…issot (SGS): The main document used by anyone characterizing a therapeutic protein remains the ICH Q6B guidelines (4). Now these guidelines are a little outdated, mainly with regards to biophysical m…

Article Evaluating Design Margin, Edge of Failure and Process
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 2.3.1 Process-Related Considerations states (4): “Adequate design of a process and knowled…

Article Quality by design for biotechnology products—part 1
Product specifications can be proposed using a combination of approaches, consistent with the guidance in ICH Q6B (Figure 2).20 Where appropriate, certain attribute specifications are based on existin…

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