Search results for "contract development and manufactur…"
Article
Contract Manufacturing Through the Years
Contract development and manufacturing organizations (CDMOs) have long played a part in the industry’s growth, but it is only in the past 20 years that they have become a critical element in bio/pharm…
Article
Maximum Output Starts with Optimized Upstream Processing
CDMOs [contract development and manufacturing organizations] must provide flexibility to address bottlenecks, like taking the most streamlined path possible, decoupling upstream and downstream process…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
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
Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges.
By Cynthia A. Challener
sdecoret/Stock.Adobe.com
Pr…
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
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Modular Manufacturing Platforms for Biologics
Contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) have traditionally viewed modular approaches as too expensive and, as a result, have been r…
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…
Article
Mapping a Route for Cell and Gene Therapy Process Development
The focus for many manufacturers, whether innovators or contract development and manufacturing organizations (CDMOs), is on automation. “Many CDMOs are now integrating sufficiently flexible production…