Search results for " process"
Article
GMP Challenges for Advanced Therapy Medicinal Products
They lack the regulatory expertise and resources to establish and operate GMP-compliant manufacturing processes. In particular, they often do not have adequate systems in place for evaluating the qual…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
…rs or flaws in one or more of the following, non-discrete categories of the research and publication process: biological reagents and reference materials, study design, laboratory protocols, and data…
Poster
Purification of monoclonal antibodies using modern chromatography media and membranes
This white paper is a guide to the development of MAb purification platforms and provides an overview of Cytiva’s offering of process chromatography media (resins) and membranes for MAb purification…
Poster
One-step seed culture expansion from one vial of high-density cell bank to 2000 L production bioreactor
This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes.
Article
Ensuring the Quality of Biologicals
The elaboration of biological monographs is a tiered process starting with the originator product, but the monograph may be subsequently adapted to account for biosimilar products. For complex biologi…
Article
Drug Discovery and Development in India
“There is a need for speeding the regulatory processes at all stages of drug development starting from seeking licenses for initiating drug discovery, conducting clinical trials in India to obtaining …
Article
FDA Approves First Biosimilar
Legal issues linger
Amgen has alleged that Sandoz purposely did not share with Amgen its 351(k) biologics license application (BLA) for filgrastim, its manufacturing processes, and dossier for the…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
Therefore, matching the binding activities of a biosimilar candidate to those of the reference product is part of the process of developing a biosimilar and something that is expected by both the Euro…
Article
What Drove Biopharma Development in 2014?
In 2014, there was significant increased interest in continuous processing, both upstream and downstream. On the PDF site, this trend was evident based on webinar invitations, as well as in published …
Article
Biopharma Manufacturers Respond to Ebola Crisis
DOD research agencies have supported development of this process for “infecting” tobacco plants with an anti-viral protein that then can be extracted and processed into a purified serum. There has bee…