Search results for "microbiological testing"
Article
Microbiological Testing: Time is of the Essence
Challener
Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbi…
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
Bioburden Control in the Biopharmaceutical Industry
Microbiological Testing Has its Limitations
Reliance on only quality control tests to judge the safe release of the final product to the market may be misleading because of the nature of the…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
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.
A…
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
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…