BioPharm International
April 01, 2019
Features
32
4
Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
April 01, 2019
Ask the Expert
32
4
A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
April 01, 2019
Regulatory Beat
32
4
FDA is moving to shift industry away from step-wise batch production.
April 01, 2019
Features
32
4
To achieve further cost reductions in biosimilar manufacturing, a move away from traditional models is necessary.
April 01, 2019
Features
32
4
A look at the Univercells' NevoLine bio manufacturing platform, which incorporates principles of automated and continuous bioprocessing.
April 01, 2019
Features
32
4
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
April 01, 2019
Features
32
4
Globally accepted products are becoming increasingly in demand, leading to more need for regulatory harmonization, particularly for biosimilars.
April 01, 2019
Features
32
4
While it may not be getting easier, biopharma patent protection is at least becoming more predictable.
April 01, 2019
Features
32
4
The latest advances in downstream processing include remote monitoring, membrane chromatography technology, single-use sensors, and new uses of data analytics.
April 01, 2019
Features
32
4
Technical advances in process understanding and control must be accompanied by a change in mindset.
April 01, 2019
Cover Story
32
4
Getting the science right helps biopharma startups overcome development and commercialization challenges.
April 01, 2019
Features
32
4
As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
April 01, 2019
From the Editor
32
4
Promoting patient compliance with drug regimens extends beyond the formulation laboratory.
April 01, 2019
Issue PDF
32
4
Click the title above to open the BioPharm International April 2019 issue in an interactive PDF format.
April 01, 2019
Features
32
4
Drug makers continue to explore innovative ways to develop antibody-drug conjugates based on their unique potential to neutralize cancer cells.
April 01, 2019
Features
32
4
A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.