Stabilization of HAC1 Influenza Vaccine by Spray Drying: Formulation Development and Process Scale-Up

Abstract

This study demonstrates the feasibility of stabilizing subunit vaccines using a spray-drying process and the suitability of the process for manufacturing a candidate product.

Advantages and challenges of the spray-drying technology for the production of pure drug particles and drug-loaded polymeric carriers

“…All three batches maintained stable physical properties and antigen content throughout the 6-month stability study at storage temperatures from -20ºC to 50 ºC. Moreover, they induced an immune response that was equivalent to the bulk HAC1 vaccine control, suggesting that the pilot scale process did not alter the immunogenicity of the HAC1 antigen and that the production process is amenable to industrial scale production [54]. adjusted.…”

“…Thus, yields are high in larger scale setups because the fraction lost is an increasingly smaller component of the total production volume [37,54], while in laboratory scale they are still far from optimal, the yield being in the 20-70% range [5,12,14]. Generally, low yield is [56].…”

“…Table 3 summarizes the major differences between both systems. Zhu et al developed a formulation and production process at pilot scale to stabilize a recombinant hemagglutinin (rHA) influenza antigen, HAC1, as a model vaccine candidate [54]. First, eight HAC1 formulations containing different excipients were produced using the Mini Spray Dryer B-290 and powders were characterized by differential scanning calorimetry (DSC), X-ray powder diffraction (XRD) and SEM.…”

Developments in the formulation and delivery of spray dried vaccines

“… 11 It has gained significant attention in formulating dried vaccines for its ease of use and potential for simple scale-up. 12 …”

“…Therefore, extensive engineering would be required to ensure that the dried vaccine product created at higher production rates, meets the properties of the initially designed product. Zhu et al 12 developed a stable spray dried recombinant influenza vaccine and scaled it up, producing 3 consistent batches of ∼50 g on a pilot scale dryer. In past, a commercial spray dried inhaled insulin Exubera® was marketed by Pfizer for treatment of Type 1 and Type 2 diabetes, but was withdrawn from the market for reason unrelated to spray drying manufacturing.…”