Search results for " scale-down models"
Article
Report from the 6th International HTPD Conference
The biggest challenge is still the people and Quantitative Structure-Activity Relationship (QSAR) plus mechanistic modeling were two key take-home messages from the 6th International conference devote…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
Putting Viral Clearance Capabilities to the Test
“A lack of appropriate scale-down models and strategies to support changes in industry practices such as continuous processing can restrict the design of the viral clearance study,” Smith says. “As ne…
Article
Tools for Continuous Bioprocessing Development
Reliable and standardized scale-down models would allow large-scale manufacturing and product development to be decoupled. If the large-scale bioreactor is well characterized, a small-scale system can…
Article
Being Thorough When Transferring Technology
…cs): The major challenges in technology transfer for any modality exist when there are known gaps in scale-down models or if the scalability from the small-scale to large-scale is unknown; for exampl…
Article
Maximum Output Starts with Optimized Upstream Processing
Furthermore, Chilima observes that by using scalable technologies that have representative scale-down models early in the process development, companies are able to evaluate the capacity needed early …
Article
Scaling Up Novel Therapies
The obvious target for scale-down models that accurately mimic larger scale equipment is in cases where pilot or industrial runs are most expensive (e.g., chromatography process steps or cell culture)…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.
Jun 01, 2015
By Cynthia A. Challener
BioPharm Inte…
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Poster
Reduce Risk of Failure in Your Virus Clearance Study by Choosing Robust Scale-Down Chromatography Tools
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. Vi…