Search results for " productivity"

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Quality by design for biotechnology products—part 2
The focus in cell culture is on consistency, productivity, product integrity, and freedom from contamination. The focus of purification is on purity and freedom from process and related materials. …

Article Quality by design for biotechnology products—part 3
Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals. By Taruna Arora, …

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment. A critical quality attribute (CQA) has been defined as “a physical, chemical, …

Article Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…

Article Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Improved manufacturing agility and productivity Biomanufacturing based on single-use technology offers great flexibility compared with traditional stainless steel facilities. Production lines can m…

Article Antibody Production in Microbial Hosts
Many advances such as translation region initiation (TIR) optimization, engineering of secretion pathways, and co-expression of molecular chaperones have been made for enhancing antibody productivity

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 Concentrating Feed—an Applicable Approach to Improve Antibody Production
Because the feed dilutes the culture and reduces product concentration, the use of lower feed volumes can improve overall process productivity as well. One approach of decreasing feed vol…

Article Achieving Greater Efficiency in the Production of Biosimilar Antibodies
The biosimilars market is set to reach more than US$20 billion in 2020 and both established biopharma and younger therapeutic manufacturers will play their part in meeting demand. Despite growing re…

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