Search results for " characterization"

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 N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products. By Aled Jones Protein glycosylation, the addi…

Article Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. By Cynthia A. Challener Manufacture of protein and other biologic drug substances via …

Article A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media. By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…

Article Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes. By Cynthia A. Challener Biopharmaceutical manufacturing involves a series o…

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 Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle. T…

Article Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…

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 The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…

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