Search results for "development"
Article
Validation of the production of influenza virus in ReadyToProcess WAVE™ 25 bioreactor system
This application note describes the validation of the single-use ReadyToProcess WAVE 25 rocking bioreactor system in production of influenza virus from Vero cells in microcarrier-based cultures. A 2…
Article
A Platform Approach to Purification of Antibody Fragments
However, with recent developments of novel affinity chromatography resins, there are new emerging possibilities. Here, we present affinity chromatography resins that offer the possibility of a platfor…
Poster
Guide to modern BioProcess™ chromatography resins
During method and process development, chromatography resins are selected and tested. In this guide, you can find help to select the resins suitable for your application.
Article
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
Article
Simplify chromatography method creation
Method creation is an essential part of preparing for automated protein purification runs. To save time and effort, method creation can be simplified and you can get to the point where you can start…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Poster
Columns up to 1600 mm in diameter packed with protein A chromatography medium using axial mechanical compression
Axial compression allows for optimally packed beds also in the large-scale chromatography column range. Different methods have been developed to pack a broad range of chromatography media (resins) i…
Poster
Residual DNA analysis in influenza vaccine processing
In cell-based influenza vaccine production, the European Pharmacopoeia demands a host cell residual DNA concentration of less than 10 ng per dose. To reliably measure residual DNA in both process sa…
Poster
Integration of continuous upstream and downstream operations in mAb production
Process intensification is gaining interest as a strategy to reduce production costs, while improving product quality and throughput in the manufacturing of biopharmaceuticals. For a competitive pro…
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Techniques to screen and characterize large numbers of antibodies and provide confident selection of the best candidates for development are therefore essential. Biacore 4000 equipped with Biacore 400…