Search results for " quality"
Article
Vaccine Development Faces Urgency and Challenges
The extensive process was needed to document unchanged quality attributes of the adjuvant under a new automated quality control system.
Similarly, Wilson Forsyth, director of quality control at As…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…n made to improve recombinant protein production to meet the demands of high quantity and consistent quality of biopharmaceutical products. Those efforts can be categorized into two fundamental areas…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
…y in accordance with existing legal and regulatory standards, guidance, and Agency policy related to quality assessment.” The ETT will assess if proposed technology will improve the quality of manufa…
Article
Viral Clearance Challenges in Bioprocessing
In these cases, close monitoring of the process, preferably using automated systems, and a good quality assurance/quality control program are essential for preventing such problems, according to Zhou.…
Article
DoE Provides Benefits, but Preparation Is Necessary
“The quantitative models for these multiple quality attributes can then be used for global optimization of the formulation, leading to more robust formulation development,” she says. Nguyen also notes…
Article
Evaluating Design Margin, Edge of Failure and Process
…rs safely (without failure or high amounts of degradation) can be processed and achieve all critical quality attributes (CQAs) and associated product acceptance criteria. Knowledge of product or proc…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
These approaches did not affect product quality and were effective for multiple cell lines and applicable for large-scale manufacturing.
Recombinant protein production in the biopharmaceutical …
Article
Raw Material Variability
Raw material variability may lead to quality compliance issues, process inconsistency, or bioprocess productivity problems. Many of these issues would be upstream in the cell-culture or fermentation s…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
…):
• Preventing entry of contamination into production processes by ensuring the quality of raw materials
• Detecting contaminants by characterization of cell banks/virus seed stocks …
Article
CoAs Help Secure the Supply Chain
The International Pharmaceutical Excipients Council defines a CoA as “a legal document that certifies the quality of the excipient and demonstrates the batch conforms to defined specifications, has be…