Search results for " methods" in Articles / App Notes
Article
A Platform Approach to Purification of Antibody Fragments
Antibody fragments constitute a promising class of biopharmaceutical products. As compared with full length antibodies, their fragments have unique properties that make them favorable for certain th…
Article
Efforts Accelerate to Streamline Postapproval Change Process
…ease batch size, shift to a new manufacturing facility, or improve process robustness and analytical methods.
Expanded global sourcing and sales complicates lifecycle product management, though, …
Article
Perfusion in the 21st Century
Perfusion support
One of the challenges faced by all companies that are exploring use of perfusion processes is the limited ability to use high-throughput methods in perfusion mode. Currently, the…
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…
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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…
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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…
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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…
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…