BioPharm International-04-01-2019

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

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.

FDA is moving to shift industry away from step-wise batch production.

To achieve further cost reductions in biosimilar manufacturing, a move away from traditional models is necessary.

A look at the Univercells' NevoLine bio manufacturing platform, which incorporates principles of automated and continuous bioprocessing.

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.

Globally accepted products are becoming increasingly in demand, leading to more need for regulatory harmonization, particularly for biosimilars.

While it may not be getting easier, biopharma patent protection is at least becoming more predictable.

The latest advances in downstream processing include remote monitoring, membrane chromatography technology, single-use sensors, and new uses of data analytics.

Technical advances in process understanding and control must be accompanied by a change in mindset.

Getting the science right helps biopharma startups overcome development and commercialization challenges.

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

Promoting patient compliance with drug regimens extends beyond the formulation laboratory.

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Drug makers continue to explore innovative ways to develop antibody-drug conjugates based on their unique potential to neutralize cancer cells.

A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.