Elements of Biopharmaceutical Production Series

Published on: 

Articles from Elements of Biopharmaceutical Production series
by Anurag Rathore and coauthors

Key Considerations for Development and Production of Vaccine Products
March 2012

Development and Commercialization of Biosimilars in India
November 2011

Challenges and Trends in Vaccine Manufacturing
October 2011

Operational Excellence: More Data or Smarter Approach?
June 2011

PDA's New Technical Report for Biotech Cleaning Validation
March 2011

Achieving Process Intensification by Scheduling and Debottlenecking Biotech Processes
February 2011

Managing Raw Materials in the QbD Paradigm
Part 1: Understanding Risks: November 2010Part 2: Risk Assessment and Communication: December 2010

Setting Specifications for a Biotech Therapeutic Product in the Quality by Design Paradigm
January 2010

Future Technologies for Efficient Manufacturing
February 2009

Quality by Design for Biopharmaceuticals:
Case StudiesPart II
January 2009

Process Validation:
How much to Do and When to do it Quality by Design for Biopharmaceuticals: Defining Design Space
December 2008

Modeling of Microbial and Mammalian Unit Operations
Part I: June 2008

Modeling of Process Chromatography Unit Operation
Part II: August 2008


Filter Clogging Issues in Sterile Filtration
April 2008

Lifetime Studies for Membrane Reuse
September 2007

Quality: Design Space for Biotech Products
April 2007

Applications of MVDA in Biotech Processing
October 2007

Applying PAT to Biotech Unit Operations
August 2006

Efficiency Measurements for Chromatography Columns
August 2005

Scaling Down Fermentation Part I: March 2005

Scaling Down Chromatography and Filtration
Part II: April 2005

Optimization, Scale-up, and Validation Issues in Filtration
Part I: August 2004 Part II: September 2004

Costing Issues in the Production of Biopharmaceuticals
February 2004

Economic Analysis as a Tool for Process Development


For the entire Elements of Biopharmaceutical Production series, please visit www.industrymatter.com/EBPseries.aspx