Search results for " production" in Articles / App Notes

Article Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO. By Jim Miller While industry participants and observers talk about the “CMO industry,” they know that …

Article Microbiological Testing: Time is of the Essence
“Microbiological testing for these therapies may need to be performed at the production site in order to avoid additional delays due to the need for the shipment of samples,” he says. Ortiz also no…

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Film samples were selected from standard production conditions or were prototypes manufactured explicitly for this case study. Cellbag culture chambers (containers) were manufactured at a Cytiva pilot…

Article Outsourcing Trends in Biopharmaceutical Manufacturing
According to BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1), outsourcing and off-shoring have migrated into much more high-value areas…

Article Best Practices in Adopting Single-Use Systems
The adoption of single-use systems in biopharmaceutical production originated with the desire to minimize cleaning and associated validation. Before long, bioprocessors recognized the value of flexibi…

Article FDA Seeks Metrics to Define Drug Quality
FDA is seeking new strategies to spur compliance with GMPs and to limit drug production errors that lead to supply problems, Woodcock explained at a July 10, 2013 seminar on “Understanding cGMPs” spon…

Article Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…

Article Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
With the exception of a few “blockbuster” monoclonal antibody products, which are better suited to large-scale stainless-steel bioreactor production, most biopharmaceutical companies are now increasin…

Article A Look at the Affinity Chromatography Landscape
Affinity chromatography for viral vectors Viral vectors are required for the production of gene therapies and the gene modification of cells used in various cell therapies. The greatest demand is …

Article Development of Purification for Challenging Fc-Fusion Proteins
Monoclonal antibody purification processes exist in different well-established platforms with extensive process performance histories for production of commercial mAbs (6-10), which typically consist …

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