Search results for "quality" in Articles / App Notes
Article
Innovation vs. Capacity: How CMOs Compete
…o support development and manufacture of novel drugs and formulations
• Strong regulatory and quality assurance (QA) capabilities that support dependable registration and approval of new drugs at…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
A paper survey is commonly used to evaluate a supplier’s quality systems. Then an additional questionnaire can be used for collecting the important information regarding each individual material of in…
Article
Antibody Production in Microbial Hosts
Cell-culture process parameters affecting the glycosylation level of mAbs also need to be controlled to ensure consistent product quality (6). Selection of a stable antibody-producing clone is also a …
Article
Biopharma in 2015: A Year for Approvals and Innovations
…ermentation equipment
A Bright Future for the Plasma Fractionation Industry
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
References
1. 2015 New Drug…
Article
Biacore Concentration and Ligand-Binding Analyses
During development and in quality control, a range of analytical technologies are used to characterize biotherapeutic drugs in terms of their structural integrity and activity. In this white
paper, …
Article
Selecting the Right Viral Clearance Technology
“These dedicated viral clearance steps are well established in the industry, and as long as they are operated within established ranges and the product quality is not impacted, virus reduction can usu…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
These range from better analytical testing and product release services to better operations staff training, optimized media and improved existing quality management systems. Better process developmen…
Article
Vaccine Development and Production Challenges Manufacturers
Researchers are looking for formulations that reduce cold-chain requirements, methods to boost process yield, and new approaches to document product quality.
Some global health advocates, however, …
Article
Finding Opportunities in Brazil
What experts and journalists hoped was that the popular government party would look after the population and improve the quality of life, while moving persons from the poverty level to the middle clas…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Disposable columns are often more difficult than the system for our customers to implement, due to quality assurance reasons. The chromatography medium is the means by which protein purification is pe…