Search results for " method"
Article
Design and Qualification of Single-Use Systems
Applicable test methods for pre-use qualification are detailed in Bio-Process Systems Alliance (BPSA’s) Quality Test Reference Matrices document, along with supplemental BPSA guides with specific reco…
Article
Biosimilars: Making the Switch Comes with Challenges
At the start of EMA’s regulating of biosimilars, there were doubts about whether the existing analytical methods for characterizing biologicals, especially complex ones, were adequate, said Martina We…
Article
Fast Turnaround with Automated Column Packing
Preprogrammed, verified, and automated packing methods, together with a purposeful column design, enable one operator to quickly achieve packing success, independent of previous experience.
To lea…
Poster
Unlocking the potential for efficiency in downstream bioprocesses
This white paper covers methods of improving downstream operations through process intensification. It describes techniques like continuous processing and in-line conditioning buffer preparation, syst…
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
This method provides rapid screening in combination with data-rich selection of fragments with high affinity and the desired kinetic behavior. Kinetic analysis at different temperatures provided addit…
Poster
Biacore™ systems in vaccine development and production
To step up to the challenge, the vaccine industry is adopting new development methods as well as improved and more flexible manufacturing principles to increase production efficiency while assuring va…
Article
Innovative Therapies Require Modern Manufacturing Systems
The aim is to avoid delays that could discourage the adoption of new production methods able to improve drug safety and quality (4).
Global harmonization
Further global harmonization of drug-d…
Article
Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
By Anurag S. Rathore, Jyot…
Article
Going Small to Achieve Success on the Commercial Scale
“While the consideration of up-front risk assessments, access to general scientific understanding, and the use of design-of-experiment (DoE) methodology minimizes the required number of runs and maxim…
Article
Fluid Handling in Biopharma Facilities
Whereas powder applications are typically handled in clean and controlled manner, fluids often need to be managed by an aseptic or validated sterile method.
BioPharm: What storage concerns are ass…