Search results for "bioprocess development"
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
Article
QbD and PAT in Upstream and Downstream Processing
McKnight, PhD, principal engineer, late stage cell culture, BioProcess Development, Genentech; Anurag Rathore, professor, Indian Institute of Technology (IIT) Delhi; Frederic Girard, CEO, Spinnovation…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
What is process development?
Bioprocess development is often divided into upstream process development and downstream process development. Those activities must be combined with the right analytics, so you can accurately measure …
Article
Process Development: 2020 Reflections and 2021 Possibilities
To shed light on what 2021 could have in store for the industry, let’s take a look at the Bioprocess Development Forum articles from 2020 that readers found most interesting and relevant during such a…
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Since 2003, BioPlan Associates, Inc. of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity …
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.
By Cynthia A. Challener
As upstream processing drives toward higher efficiencies in meeti…
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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
Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …