Search results for " activity"
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
Challenges of Protein Aggregation During Purification
Careful selection of downstream processing conditions is a must.
Sep 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 27, Issue 9, pp. 32-35
Removal of protein a…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
Recent activity and future expectations
In addition to its approval in the EU, Celltrion has received approval for Remsima in South Korea and Canada, and has applied for approval in Japan. The comp…
Article
Early Communication with Regulators is Essential for SMEs
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Cause-and-effect matrix
Once risk levels have been assigned to the CQAs, the next activity is to begin to relate which parts of the process have impact on these attributes. This cause-and-effect a…
Article
Implementing QbD in Sterile Manufacturing
To gain perspective on the implementation of quality by design (QbD) in sterile manufacturing, BioPharm International spoke with Wolfgang Weikmann, vice-president quality assurance at Vetter Pharma-Fe…
Article
Trends in Downstream Bioprocessing
So the issue is, what can we do to increase the concentration of protein in solution without decreasing yields or activity?”
On-going research into new technologies being developed in this industr…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
Article
Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…