Search results for " variability" in Articles / App Notes
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
Q&As with Industry Leaders
…;Strategic Technology Partnerships Leader, Cytiva
What's in Your Media? How Costly is Variability of Cell Culture Media to Your Manufacturing Process?
Megan Manzano, BioPharm Interna…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
Article
2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
…ring processes and methods that pose quality risks, such as product contamination, excessive process variability, and lack of consistent product quality. Regulatory authorities approved these process…
Article
FDA Seeks Metrics to Define Drug Quality
Process and product performance index (Ppk) values similarly can be a sign of an optimal control strategy supported by in-depth understanding of the causes of variability for both products and process…
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…