Search results for " cell"
Article
Understanding Validation and Technical Transfer, Part 3
Non-traditional process validation
The following example of production of cells used in autologous cellular immunotherapies for personalized medicine demonstrates how some conventional validation …
Article
Antibody Production in Microbial Hosts
Mammalian cells have been primarily applied as the hosts of choice for mAb expression. However, clinical success of mAbs has tremendously increased their demand, and this in turn has fueled interest i…
Article
QbD and PAT in Upstream and Downstream Processing
McKnight, PhD, principal engineer, late stage cell culture, BioProcess Development, Genentech; Anurag Rathore, professor, Indian Institute of Technology (IIT) Delhi; Frederic Girard, CEO, Spinnovation…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
Genetic vaccines use part of the virus’ own genetic code (either mRNA or DNA) to instruct cells to make a viral antigen that will stimulate an immune response. Viral-vectored vaccines allow selection …
Article
Single-use Bioreactors Have Reached the Big Time
Suppliers of single-use bioreactors continue to work closely with customers to address changing needs, such as those for next-generation cell- and gene-therapies and continuous bioprocessing.
“The…
Article
Reconciling Sensor Communication Gaps
Historically, cell culture and fermentation persist longest among unit operations. Expression is “where the action is—where throughput and volumetric productivity exert the greatest influence on cost …
Article
The Development and Application of a Monoclonal Antibody Purification Platform
…al Biologics division, including how the individual unit operations have been affected by increasing cell culture titers and subsequent changes in the impurity profile, as well as viral clearance iss…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of B…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Large-scale mammalian cell culture is used for the manufacture of all therapeutic glycoproteins (TGPs), with Chinese hamster ovary (CHO) and murine myeloma (NS0 and Sp2/0) cell lines being the most-co…
Article
Impurity Testing of Biologic Drug Products
Some impurities (especially host cell proteins) may add an immune-stimulating or adjuvant behavior to the therapeutic, causing the patient to generate antibodies or cell-mediated immunity against the …