Search results for " methods"
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
Antibodies and their derivatives are increasingly important as biotherapeutics, precision diagnostics, and essential tools for biological research. Techniques to screen and characterize large number…
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
Existing technology is highly valuable
“Despite the limitations of existing scale-down modeling methods, the use of scaled-down models is recommended wherever possible, including for process chara…
Article
Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…