Felicity Thomas

Companies need to consider and address formulation challenges to employ a successful reformulation strategy.

A thorough knowledge of both the upstream and downstream processes is required to ensure effective removal of residual impurities in biopharmaceuticals.

There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

An increasingly complex development pipeline and industry considerations, such as sustainability, are leading to a greater need for more efficient separation and purification in downstream processing.

Advances in therapeutic modalities and an increase in molecular complexity have led to the need for an evolution in drug delivery approaches over the years.

As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.

Emerging drug classes are giving rise to challenges in downstream processing, pushing the need for strategizing efficiencies.

Scientists can work to overcome the challenges associated with protein characterization through empowering technologies.

Experience is an invaluable asset for outsourcing partners, particularly as more challenging method development services are in demand.