Search results for "Scale down"
Article
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
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Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
Article
The Outlook for CMO Outsourcing in 2019
By Eric Langer and Ronald A. Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial AP…
Article
A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
By Cynthia A. Challener
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Poster
Scalable Continuous Chromatography Process for Enhanced Efficiency in Biomanufacturing
The cost pressure on biopharmaceuticals drives the industry toward exploring process intensification options that will maintain or improve quality, stability, and manufacturability of the product wh…
Article
Process Economy Simulations on a Protein A Capture Step
MabSelect PrismA is a next‐generation protein A chromatography resin that offers significantly enhanced alkaline stability and capacity compared with its predecessor products. This application note …
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Poster
A Scalable Adenovirus Production Process
The promising results from clinical studies on the use of viral vectors to address important medical needs have spurred interest in developing scalable and cost-efficient manufacturing processes. To…
Article
Process Economic Simulation for Scalable Production of Adenovirus
This application note discloses the process economic modelling of a modern start-to-finish adenovirus production process. The novel process was compared with a reference process in both stainless-st…
Article
Challenges in Cell Harvesting Prompt Enhancements
Challenges in Cell Harvesting Prompt Enhancements
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
By Feliza Mi…