Search results for " sourcing"

Article Aseptic Processing: Keeping it Safe
Microbial, chemical, or endotoxin contaminants in feed water sources can occur in excess of a system’s ability to clear them, and this has periodically been a problem with water sourcing, says Newman.…

Article Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015 By Thomas A. Little, PhD BioPharm International Volume 28, Issue 7, pg 40–44 Approaches to the generation of process models, optimization techniques, and application of …

Article Optimization of Protein Expression in Escherichia Coli
May 01, 2015 By Siavash Bashiri, David Vikström, Nurzian Ismail BioPharm International Volume 28, Issue 5 Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…

Article Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015 By Anurag S. Rathore, Sumit K. Singh BioPharm International The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…

Article Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions. Dec 01, 2014 By Cynthia Challener, PhD BioPharm International A key component of the quality-by-design (QbD) ap…

Article Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission. By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh BioPharm Inter…

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 Raw Material Variability
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials. It would seem that raw materials used in bioprocessing operations are a relatively straig…

Article The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare. The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…

Article Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space. Design space is generally considered to be the areas where the product or process parameters can be run safe…

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