Recent progress in drying technologies for improving the stability and delivery efficiency of biopharmaceuticals

Abstract

Background Most biopharmaceuticals are developed in liquid dosage forms that are less stable than solid forms. To ensure the stability of biopharmaceuticals, it is critical to use an effective drying technique in the presence of an appropriate stabilizing excipient. Various drying techniques are available for this purpose, such as freeze drying or lyophilization, spray drying, spray freeze-drying, supercritical fluid drying, particle replication in nonwetting templates, and fluidized bed drying. Area covered In this review, we discuss drying technologies and their applications in the production of stable solid-state biopharmaceuticals, providing examples of commercially available products or clinical trial formulations. Alongside this, we also review how different analytical methods may be utilized in the evaluation of aerosol performance and powder characteristics of dried protein powders. Finally, we assess the protein integrity in terms of conformational and physicochemical stability and biological activity. Expert opinion With the aim of treating either infectious respiratory diseases or systemic disorders, inhaled biopharmaceuticals reduce both therapeutic dose and cost of therapy. Drying methods in the presence of optimized protein/stabilizer combinations, produce solid dosage forms of proteins with greater stability. A suitable drying method was chosen, and the process parameters were optimized based on the route of protein administration. With the ongoing trend of addressing deficiencies in biopharmaceutical production, developing new methods to replace conventional drying methods, and investigating novel excipients for more efficient stabilizing effects, these products have the potential to dominate the pharmaceutical industry in the future.

Accelerated Production of Biopharmaceuticals via Microwave-Assisted Freeze-Drying (MFD)

“…With emerging patient-centered drug manufacturing in the biopharmaceutical industry [ 5 ], small batch sizes create an increasing need for time-saving technologies and flexibility. Hence, numerous new drying technologies and approaches are being developed to speed up the lengthy process [ 1 , 6 , 7 , 8 , 9 ].…”

Practical Considerations for Next-Generation Adjuvant Development and Translation

“…In particular, more effort is needed in the development of thermostable adjuvant-containing vaccines [ 39 , 40 ]. Generating a thermostabilized product often necessitates reducing the water activity of a product to slow the rate of hydrolysis and other aqueous-phase decomposing processes, which are the major driving forces in antigen and adjuvant degradation [ 41 , 42 ]. This is often accomplished by generating a dried product, generally either through lyophilization or spray drying [ 42 ].…”

“…Generating a thermostabilized product often necessitates reducing the water activity of a product to slow the rate of hydrolysis and other aqueous-phase decomposing processes, which are the major driving forces in antigen and adjuvant degradation [ 41 , 42 ]. This is often accomplished by generating a dried product, generally either through lyophilization or spray drying [ 42 ]. However, transforming liquid adjuvant formulations into solid-state formulations with enhanced thermostability is not a trivial endeavor due to the complexities of adjuvant particulate structures.…”

Effect of a novel drying method based on supercritical carbon dioxide on the physicochemical properties of sorghum proteins

“…15 However, freeze-drying is a time and money-consuming process, and it is considered the most expensive drying process because of the high operation and maintenance costs. 14,16 In the spray-drying process, on the other hand, the uid is directly atomized, and hot air comes directly in contact with the spray of droplets. 17 Despite some advantages, 18 there are some drawbacks, such as high temperature application, high energy consumption, work scale dependent yield, and the need for excipients.…”

“… 13 Freeze drying or lyophilization consists of freezing, primary drying, and secondary drying. 14 Freeze-drying is usually considered as a gentle drying method. 15 However, freeze-drying is a time and money-consuming process, and it is considered the most expensive drying process because of the high operation and maintenance costs.…”