Search results for " facility"
Article
Mixing dynamics in a large volume single use mixer
Large volume single-use technology mixers can be used for mixing operations throughout the entire bioprocess workflow. Large-volume mixers are mainly required in clinical three-scale and production…
Article
Single-use technologies in downstream process intensification
When using conventional chromatography solutions, cleaning and cleaning validation consumes a considerable amount of time and facility resources. Cleaning-in-place protocols are performed before, duri…
Article
Continuous Processing for the Production of Biopharmaceuticals
The key distinguishing features of this facility were uninterrupted and fully automated purification, steady-state operation, and consistent product quality throughout operation time. In addition to e…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA, the European Medicines Agency, and other established authorities, moreover, are collaborating more to avoid duplication in drug facility inspections and in the registration of innovative medicine…
Article
Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…
Article
Tools for Continuous Bioprocessing Development
In 2008, FDA rejected Genzyme’s application to produce Myozyme in a 2000-liter-scale facility under the same approval authorization given for its 160-liter-scale plant. The FDA ruling stated that the …
Article
mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
Article
GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
Article
Selecting the Right Viral Clearance Technology
“When those processes advance to commercial production with regular manufacturing and carefully orchestrated facility constraints, however, any variation in performance from batch to batch can disrupt…
Poster
Process economy and production capacity using single-use versus stainless steel fermentation equipment
This white paper compares production capacity and process economy between stainless steel and single-use equipment in microbial processes. Economy simulations were based on an E. coli Dab process. P…