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Article Platform Technologies Improve Protein Expression
In addition, new technologies for genomic engineering of cells for the production of therapeutic proteins are “opening up a new world of possibilities to tailor-make protein-based drugs with appropria…

Article Unifying Continuous Biomanufacturing Operations
By Randi Hernandez When human cells travel throughout the body, they are constantly being influenced by the environment around them. The most efficient upstream processing systems in biologics man…

Article Ensuring Viral Safety of Viral Vaccines and Vectors
Since then, better safety measures and the use of established and characterized cell lines have improved safety in biologicals. To date, no infectious virus has been transmitted to a patient by a 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…

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