As the therapeutic landscape grows more complex, so too must the analytical techniques for cleaning validation to ensure the utmost cleanliness is achieved.
Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.
Alternative approaches to freeze drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.
Particle engineering can be a resourceful tool to advance drug candidates by offering drug delivery innovation.
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.