Search results for " process"
Article
Robust Optimization, Simulation, and Effective Design Space
Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
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Article
Evaluating the Use of Continuous Chromatography
In downstream processing, continuous chromatography is gaining traction in the purification of protein therapeutics. As the biopharmaceutical industry strives to demonstrate, continuous manufacturing …
Article
Evaluating E&L Studies for Single-Use Systems
for manufacturing processes, in addition to multi-use (MU) materials (i.e., glass bottles, stainless steel tanks, etc.) (1). Regulatory guidelines require that the product contact items “shall not be …
Article
Single-use Bioreactors Have Reached the Big Time
… attractive, while stainless steel or hybrid approaches are typically better suited for large-volume processes for the manufacture of a single product.
Rapid expansion of the single-use bioreacto…
Article
Viral Clearance Challenges in Bioprocessing
…as one of the most efficient and robust virus removal steps, and implementation in the media feeding process could decrease the risk of contamination significantly, according to Horst Ruppach, senior…
Article
Essentials in Establishing and Using Design Space
Design space is generally considered to be the areas where the product or process parameters can be run safely (without failure or high amounts of degradation) and achieve all critical quality attribu…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
For most biologics, therefore, sterility must be assured by using aseptic processing techniques, which involve use of sterile raw materials, equipment, and processes under conditions that prevent micr…
Article
Improving Upstream Predictability
Today, better understanding of cells and how they interact with their environment has enabled improvements in most aspects of upstream processing, from bioreactor design and media development to proce…
Article
Improving Process-Scale Chromatography
By Cynthia Challener, PhD
Chromatography is a crucial step in the purification of biopharmaceuticals and accounts for a significant portion of downstream processing efforts (time and cost) for bio…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies, along with continuous processing approaches, are helping the industry both modernize old processes and facilities and minimize the risks associated with making sig…