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
This product was being filled by a contract manufacturing organization (CMO), which was using only water for cleaning.
During the design phase of the cleaning program, coupon testing was …
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
…irst-generation process was established by a third-party contract manufacturing organization (CMO). The molecule exhibits monoclonal antibody (mAb) behavior, however, with a challenging glycosylati…
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
…the suppliers of crucial raw materials to the fill/finish and contract manufacturing organizations (CMO), where applicable (Figure 2).
Figure 2: Effective viral risk mitigation acr…
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…