Pharmaceutical Technology - May 2021

Pharmaceutical Technology - Biologics and Sterile Drug Manufacturing - May 2021

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22 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Manufacturing temperatures during drying. As the atomized droplet evaporates within the drying chamber to create the powder, an evaporative cooling effect occurs around the droplet/powder particle, resulting in a cooler environment surround- ing the product. This feature, in combination with the short resi- dent time of a dried particle within a drying chamber, reduces the risk of the product being exposed to el- evated temperatures. Aseptic spray drying has been proven to be compatible to a range of vaccine types including sub- unit protein vaccines, aluminium- adjuvanted vaccines, RNA vaccines, and certain live-attenuated and viral-vector vaccines (Figure 2 and 3). Moreover, spray drying can be an enabling technology to deliver multivalent vaccines where compo- nents can be either individually or co-spray dried and finally blended together as a final dry product (4, 5). Spray drying is a continuous process that will allow manufacture of large batches at commercial scale. For example, one of the aseptic spray-drying systems available at Nova Laboratories, which is validated to operate continuously for more than one week, can potentially manufacture over one million thermo-stable vaccine doses. The output can be significantly further increased by at least ten-fold, using a single commercial scale spray drying system. The intermediate storage of bulk spray-dried powder should be more manageable compared with storing a frozen bulk drug substance before the final fill and finish step, enabling companies or governments to stockpile materials for distribution during a pandemic. The spray drying method can facilitate the manu- facture of stable vaccine powder with a longer shelf- life compared to their liquid formulation counterparts, which has been demonstrated with viral vector vac- cines (6–7) and other types of vaccines (8–9). Ultimately aseptic spray drying technology can reduce the overall cost of vaccination programs. It is 1.00E+08 1.00E+07 1.00E+06 1.00E+05 1.00E+04 1.00E+03 1.00E+02 1.00E+01 1.00E+00 Liquid Control Stabilised Virus Titer Sero-1 Sero-2 Sero-3 Sero-4 4.56E+07 2.36E+07 5.21E+07 3.26E+07 2.84E+07 3.07E+07 3.98E+07 3.72E+07 Figure 2. Spray drying of live attenuated flavivirus vaccine. Source: Nova Laboratories' confidential client data. Figure 3. Antibody response at 28 days for spray-dried hepatitis B vaccine. Source: Nova Laboratories' confidential client data. 100000 10000 1000 100 10 1 +ve C 0.25ug +ve C 0.5ug 2-8˚C 0.25ug 2-8˚C 0.5ug 55˚C 0.25ug 55˚C 0.5ug Storage Conditions: 10 weeks 10 MICE PER GROUP MEAN TITRE Fresh Vaccine Spray Dried Vaccine (2-8˚C) Spray Dried Vaccine (55˚C) Ab Titre (IU/ml)

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