Innovative drying technologies for manufacturing parenteral biopharmaceuticals have the potential to increase and improve the manufacturing capacity of life-saving drugs
A review from Waterford Institute of Technology (WIT) researcher, Ashutosh Sharma, titled 'Innovative Drying Technologies for Biopharmaceuticals' was recently published in the International Journal of Pharmaceutics, Elsevier.
The review was collated at PMBRC, which is part of the School of Science at WIT in collaboration with Sanofi, Waterford, and was funded by the WIT-Sanofi Co-fund Scholarship and the Irish Research Council (IRC) Enterprise Partnership Scheme (EPS).
The review includes potential drying technologies for parenteral biopharmaceuticals, a list of characterization techniques, formulation aspects, potential process analytical technologies (PAT), and scale-up, packaging and validation aspects associated with the commercial manufacturing of biologics.
The importance of biopharmecuticals
In the past two decades, biopharmaceuticals have been a breakthrough in improving the quality of lives of patients with various cancers, autoimmune, and genetic disorders. With the growing demand of biopharmaceuticals, the need for reducing manufacturing costs is essential without compromising on the safety, quality, and efficacy of products. Batch Freeze-drying is the primary commercial means of manufacturing solid biopharmaceuticals. However, Freeze-drying is an economically unfriendly means of production with long production cycles, high energy consumption and heavy capital investment, resulting in high overall costs.
Innovative drying technologies
This review compiles some potential, innovative drying technologies for manufacturing parenteral biopharmaceuticals that have not gained popularity, but have the potential to increase the manufacturing capacity and efficiency of life-saving drugs, lower costs, reduce cold chain requirements, and mitigate disruption to manufacturing during pandemics and similar impactful events. In contrast to conventional freeze-drying of biologics, novel manufacturing technologies such as Spray-Drying, and Spray Freeze-Drying will significantly reduce time, energy and associated costs.
Review will benefit academia and industry
“Studying the impact of these processes on the product through orthogonal techniques such as spectroscopy, chromatography, thermoanalytics will provide enormous information on the critical quality attributes of the product," explained Ashutosh. “By gaining insights into the process as well as the product, this review will benefit both academia and industry. Both formulation and analytics need to evolve along with modern drying technologies.”
The full review article 'Innovative Drying Technologies for Biopharmaceuticals' is available to read now in the International Journal of Pharmaceutics, Elsevier, visit: https://doi.org/10.1016/j.ijpharm.2021.121115