Search results for " manufacturing"
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…
Article
Updating Viral Clearance for New Biologic Modalities
Many of these new and evolving biotherapeutics use viruses or virus-related approaches in their manufacturing processes.
Clearance challenges
The challenge of demonstrating viral clearance in …
Article
Using Software in Process Validation
By Robert Glaser
Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…
Article
Continuous Processing for the Production of Biopharmaceuticals
By Anurag Rathore, Nikhil Kateja, Harshit Agarwal, Abhishek Kumar Sharma
Benefits of continuous processing have been widely demonstrated by a variety of manufacturing industries. With the growing …
Article
Applying GMPs to the BioPharma Supply Chain
Good manufacturing practices
Suppliers of raw materials need to understand what GMPs mean as they apply to the biopharmaceutical industry. Suppliers need to have a system for assuring the quality …
Article
Improving Upstream Predictability
Some of the latest biopharmaceutical manufacturing facility designs have cell culture and some purification unit operations take place in one location, notes Mohindra.
At the same time, the …
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Nesta
Abstract
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 sol…
Article
GMP Challenges for Advanced Therapy Medicinal Products
They lack the regulatory expertise and resources to establish and operate GMP-compliant manufacturing processes. In particular, they often do not have adequate systems in place for evaluating the qual…
Article
Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…
Article
Advancing QbD in the EU
In addition, EU authorities are becoming more concerned about the increasing number of quality defects in pharmaceutical manufacturing that have been causing a rise in drug scarcities.
ICH GUID…