Search results for " platform"
Article
Managing Biomanufacturing Capacity Expectations
If a CMO/CDMO has its own proprietary manufacturing platform, a biopharma company cannot easily transfer the process back in-house or to another CMO, Wyss points out. “If the contract manufacturing ag…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
… first human dose (FHD) or first-in-human (FIH) application, and leveraging a “commercializable” platform for cell culture and downstream process development. At the heart of this strategy is the vie…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The growth of the segment has necessitated development of new efficient and cost saving platforms for the preparation and analysis of early candidates for faster and better antibody selection and char…
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…
Article
Use of Multivariate Data Analysis in Bioprocessing
MVDA applications in cell-culture operations
Cell-culture operations are by far the most common platform used for production of protein therapeutics. In this endeavor, various advanced offline and…
Article
Re-use of Protein A Resin: Fouling and Economics
The widespread applicability and similarity of operating conditions have made Protein A chromatography the core purification operation in platform purification processes for antibodies (7, 8). Large-s…
Article
Biopharma Manufacturers Respond to Ebola Crisis
NewLink Genetics’ (Ames, Iowa) similarly has FDA approval to test its VSV-EBOV vaccine, a platform licensed by NewLink subsidiary BioProtection Systems from the Public Health Agency of Canada. DOD is …
Article
Challenges and Trends in Biopharma Facility Design
…f single-use technologies, we offer the FlexFactory, which is a centrally-automated biomanufacturing platform.
Philips (Pall Life Sciences): The ‘ballroom’ concept is often defined as a large man…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
… determining the criticality of process parameters under the following conditions:
• When a platform process that possesses similar properties and process to another commercial product (e.g., …
Article
Elucidating Biosimilars Characterization
There have also been significant advances in associated informatics platforms for the annotation of both LC and MS data in recent years.
Furthermore, the issues of glycan micro- and macroheterogen…