Search results for " assay validation"
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
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Article
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
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Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
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…
Article
Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
Article
Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
He also covered the latest regulatory strategies and a new assay validation guideline for surface plasmon resonance (SPR) technology.
Sign up to access and to view an on-demand recording.
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …