Search results for " CMO"
Article
Reducing Cross-Contamination Risks in Process Chromatography
“Single-use chromatography is an increasingly attractive option for multi-drug facilities, such as [contract manufacturing organizations] CMOs and [contract research organizations] CROs, because singl…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
Biosimilars represent an innovative solution that can benefit both patients and healthcare systems by reducing the burden of rising treatment costs. To improve the availability, price and access of…
Article
Automating Bioprocesses
Automation of stainless-steel systems and single-use systems differs in complexity.
By Jennifer Markarian
Both upstream and downstream biopharmaceutical processes have conventionally used st…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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
Optimizing Resin Performance with Disposable Chromatography Solutions
But we are also seeing adoption by CMOs and innovator molecule companies.
Cost Considerations
BioPharm: In the past two years, have there been any technological advances to improve performance…
Article
Regulatory Challenges in the QbD Paradigm
In this global environment, many biotechnology product manufacturers have multiple manufacturing sites and/or partnerships with CMOs. Their products are supplied to a global market. The need to propos…
Article
Flexibility in Biopharmaceutical Manufacturing
Many CMOs have become skilled at this and trade on their flexibility. Innovator firms are heading in the same direction.
STAINLESS STEEL VERSUS SINGLE USE
For many, the use of disposable or…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…