Search results for "continuous"
Article
A Look into the Future of Biopharmaceutical Quality
The industry seems to be moving toward a continuous monitoring where results regarding the quality of the product can be achieved in real-time. The current processes used to update procedures, systems…
Article
Integrated Semi-Continuous Process for mAb Production
Linking these different steps together to a fully continuous process can be a challenging task, and studies in the area of continuous processes typically deals with single unit operations, such as per…
Article
Challenges in Cell Harvesting Prompt Enhancements
Among the innovations are continuous processes/techniques that can mitigate the stress of high cell densities.
Centrifugation challenges
The centrifugation step uses the density difference bet…
Article
Modern Manufacturing Key to More Effective Vaccines
He noted that continuous manufacturing platforms can help ramp up vaccine supply on short notice and that FDA clarification of its requirements and standards should encourage industry investment in ne…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
Thus, the roadmap will continue to be updated in order to deal with the continuous evolution of the biopharmaceutical industry.
Munk (NNE): We are in the middle of a paradigm shift, where the di…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Downstream Processing for Cell-Based Therapies
Alternatives to swing-bucket rotor centrifugation include continuous counterflow centrifugation systems and filtration systems, which can be more amenable to large-scale, contained and automated opera…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
The delay volumes are modeled as a chain of continuous stirred tank (CSTR) and dispersed plug flow (DPFR) reactors. The mixing time of CSTR (τ1 τ2 τ3 τ4) are shown in Table II. The DPFR has length and…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
What progress has been made in process development for continuous manufacturing?
FDA has aggressively been encouraging drug license holders to modernize manufacturing processes; continuous manufac…
Article
The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…