Search results for " cell"
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Will the facility be manufacturing monoclonal antibodies, recombinant proteins, vaccines, antibody-drug conjugates, or fragment antibodies? Also, will the products be mammalian cell-derived or microbi…
Article
Biopharma Advances Demand Specialized Expertise
Reporter gene bioassays apply genetically engineered cell lines both to directly model mechanisms of action and to amplify assays for improved performance with shorter incubations and increased signal…
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USP Publishes Monoclonal Antibody Guidelines
Unlike small-molecule medicines, which have more easily defined quality attributes and are relatively easy to characterize, biologics are large-molecule drugs, typically manufactured using living cell…
Article
Viral Clearance Challenges in Bioprocessing
… minute virus of mice/porcine parvovirus [MVM/PPV]) is applied for the viral clearance validation of cell line-derived recombinant products. The achieved single reduction factors are summed up to an …
Article
Evolution of the Monoclonal Antibody Purification Platform
Typical steps include:
• Protein A chromatography for capture of the product and removal of host cell-related impurities (host cell proteins and DNA). Though extremely efficient and effective,…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Samples containing antibodies in cell culture fluid were injected onto a Protein A column for antibody recovery, then the purified antibody sample was automatically injected onto the size exclusion co…
Article
Regulatory Challenges in the QbD Paradigm
The products can be produced from the same host or from different hosts but must be from well characterized cell lines (e.g., ICH Q5A) and not highly toxic or potent. The second case is the site trans…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Future steps in the research will look into solution conditions that encourage miniaturization of the cells, neutralize cells, or filter surface charges that enhance cell entrapment on filter membrane…
Article
Innovations in Perfusion Bioprocessing
In this study, we present a method for deriving perfusion culture media by leveraging existing fed-batch media and feeds.
Furthermore, we illustrate the successful transfer of the develop…
Article
Evaluating the Use of Continuous Chromatography
Continuous processes continue to advance in bioprocessing. In downstream processing, continuous chromatography is gaining traction in the purification of protein therapeutics. As the biopharma…