Search results for " modeling"

Article Tools and methodologies for smarter downstream process development
…ing downstream methodologies and tools to make PD faster and smarter? Considering mechanistic modeling as an emerging technology, where do we stand today with mechanistic modeling? Learn…

Article Accelerating VLP purification process development
See how using mechanistic modeling can speed up the purification process development of virus-like particles (VLPs). Indeed, a method for the large-scale production of VLPs is produ…

Article Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities. By Feliza Mirasol Ensuring viral clearance (i.e., removal) in downstream purification has becom…

Article Biopharma Seeks Balance
FDA reports that it has considered emerging technologies for biological molecules including controlled ice nucleation for lyophilization processes, predictive modeling for process monitoring and close…

Article Handbook: Design of Experiments in Protein Production and Purification
Design of experiments (DoE) is a technique for planning experiments and analyzing the information obtained. The technique allows us to use a minimum number of experiments, in which we systematically v…

Article From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …

Article Automating Bioprocesses
Automation of stainless-steel systems and single-use systems differs in complexity. By Jennifer Markarian Both upstream and downstream biopharmaceutical processes have conventionally used st…

Article Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing. By Bruce Lehr, Delia Lyons Cell-culture technology for biopharmaceutical manufact…

Article Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. By Cynthia A. Challener Vaccine development is a complicated process that can take many yea…

Article Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation. Design of experiments (DOE) is a well-proven characterization approach within product…

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