Search results for "Streamline" in Articles / App Notes
Article
Efforts Accelerate to Streamline Postapproval Change Process
She and others described efforts to streamline this cumbersome and costly postapproval change process at the July 2016 CMC Strategy Forum on “Change Happens” organized by CASSS.
Gaining regulatory…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
A powder delivery system that supports non-contact, rapid identification methodologies, such as Fourier-transform infrared spectroscopy (FTIR) and Raman spectroscopy, can streamline the incoming testi…
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What’s New in Upstream Technologies
Buffer delivery component
MilliporeSigma’s BioContinuum Buffer Delivery Platform, a new component in the company’s BioContinuum Platform for next-generation bioprocessing, offers a way to streamli…
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Modern Manufacturing Key to More Effective Vaccines
And the imperative to combat infectious disease outbreaks and deadly conditions such as malaria and tuberculosis emphasizes the need to modernize and streamline vaccine testing and manufacturing.
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Process Development: 2020 Reflections and 2021 Possibilities
One efficient method is high-throughput process development (HTPD), which streamlines various bioprocess workflows to enable enhanced efficiency with parallelization and automation of experiments.
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Quality Systems Key to Lifecycle Drug Management
And new policies and procedures at FDA aim to streamline oversight of manufacturing changes for firms that adopt modern production methods able to ensure the continued safety and efficacy of products …
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Quality by Design—Bridging the Gap between Concept and Implementation
According to France, the next step involves a streamlined system of regulatory review of QbD applications that needs to be extended to a “global regulatory alignment.”
The workshop, which includ…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
These 2D methods assessed both titer and size heterogeneity of the MAbs, demonstrating a streamlined workflow, and can be used for a variety of applications, including molecule assessment and clone se…
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The Future of Biopharma
To remain competitive, especially as biosimilars and biobetters evolve, better ways of evaluating new technologies are needed that cut down on time to market and streamline the overall testing process…
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Sterilization Trends for Single-Use Consumables
The desire to streamline the process for sterility validation without compromising risk is a second important trend. Sterilization validation practices for SU consumables used in biopharmaceutical man…