Search results for "Streamline"

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…

Article 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…

Article 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…

Article 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.  …

Article 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. …

Article 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 …

Article 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…

Article 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…

Article 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…

Article Top Tips for Successful Development of Antibody Chromatography Processes
Jeanne Linke Northrop: Do you have any further recommendations that you'd like to provide to our audience about antibody therapies, process development? More specifically, what can be done to streamli…

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