Search results for " characterization" in Articles / App Notes
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
Article
Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
…
Article
Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
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…