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. 2021 Aug 23;39(36):5153-5161.
doi: 10.1016/j.vaccine.2021.07.044. Epub 2021 Aug 3.

Developing-country vaccine manufacturers' technical capabilities can make a difference in global immunization

Benoit Hayman  1 , Maureen Dennehy  2
Affiliations

Developing-country vaccine manufacturers' technical capabilities can make a difference in global immunization

Benoit Hayman et al. Vaccine. .

Abstract

Members of the Developing Countries Vaccine Manufacturers' Network (DCVMN) have been actively engaged in the development of COVID-19 vaccine candidates. According to the WHO COVID-19 vaccine landscape updated on 29 December 2020, 18 member manufacturers had vaccines in preclinical or clinical trials, including three members with candidates in Phase III trials. Once successful candidates have been identified there will be a need for large scale vaccine manufacturing and supply, in which DCVMN member manufacturers can play a key role. In an internal survey in 2019, DCVMN members reported the capability to supply over 3.5 billion vaccine doses annually, and the provision of over 50 distinct vaccines to 170 countries. To describe the capabilities of DCVMN member manufacturers more precisely, a 121-question survey was circulated to 41 Network members. The survey assessed the manufacturers' capabilities in utilizing various technology platforms, cell cultures and filling technologies, in addition to their capacities for manufacturing drug products. The survey also evaluated manufacturers' preparedness to dedicate existing capacities to COVID-19 vaccine production. Results revealed that sampled manufacturers have strong capabilities for manufacturing vaccines based on recombinant technologies, particularly with mammalian cells, and microbial and yeast expression systems. Capabilities in utilizing cell cultures were distributed across multiple cell types, however manufacturing capacities with Vero and CHO cells were prominent. Formulating and filling findings illustrated further large-scale capabilities of Network members. Sampled manufacturers reported that over 50% of their capacity for vaccine manufacturing could be dedicated to COVID-19 vaccine production.

Keywords: COVID-19 vaccines; Global supply; Manufacturing capabilities; Public health; Technology platforms.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
A. Total production volume (measured in Litres) for each of the specified vaccine technology platforms. Production volumes were quantified in each WHO region. Note: not all manufacturers who indicated they utilize the platform technology shared their specific production volume, and in some cases shared data in different units. Any responses to this question that were not in correct units were omitted from the final output. The breakdown of the omitted data for each platform technology is: RNA Vaccine Technologies: one manufacturer indicated a production volume of 50–100 million doses. Recombinant technologies using mammalian cells: two manufacturers did not share total production volumes, one manufacturer indicated that T-flasks and a cell factory were used in their production process. Microbial or Yeast expression systems: one manufacturer did not indicate total production volume In instances in which total production volume was provided as a range e.g. 1000–1500 Litres, the lower value was always used in the final output. Fig. 1B. Total number of manufacturing lines and the percentage of which could dedicated to COVID-19 vaccine manufacturing. Across all platform technologies sampled manufacturers have 63 manufacturing lines of which 35 can presently be dedicated to COVID-19 vaccines (55.6%). Note: two manufacturers indicated that their manufacturing lines would be dedicated to COVID-19 vaccine production based on market requirements. The final output includes these as being available for COVID-19 vaccine production. Fig. 1C. Number of sampled DCVMN members current implementing or planning to implement the technology platform in the next 5 years. There was also the option ‘other’ for which one manufacturing indicated pneumococcal conjugate vaccines (PCV).
Fig. 2
Fig. 2
A.Total bioreactor volume (measured in Litres) for each of the specified cell cultures. Bioreactor volumes were quantified in each WHO region. Note: not all manufacturers who indicated they utilize the cell culture shared their specific bioreactor volume, and in some cases shared data in different units. Any responses to this question that were not in correct units were omitted from the final output. Fig. 2B. Total number of manufacturing lines and the percentage of which could be dedicated to COVID-19 vaccine manufacturing. Across all cell cultures sampled manufacturers have 59 manufacturing lines of which 36 can presently be dedicated to COVID-19 vaccines (61%). Note: two manufacturers indicated that their manufacturing lines would be dedicated to COVID-19 vaccine production based on market requirements. The final output includes these as being available for COVID-19 vaccine production.
Fig. 3
Fig. 3
A. Geographical breakdown of total formulating capacity measured in litres per day. 22 of the 26 sampled manufacturers indicated capabilities for vaccine formulation. Total formulating capacity of the 22 manufacturers was estimated to be between 17,940 – 18,795 L/day. For the output the lower estimate was used. Total formulating capacity was broken into WHO regions: Western Pacific (48%), South-East Asia (37%), Americas (14%), Other (1%). Fig. 3B. Total number of formulating tanks and the percentage of which could be dedicated to COVID-19 vaccine manufacturing. Sampled manufacturers have 109 formulating tanks of which 55 can presently be dedicated to COVID-19 vaccines (50%). Note: one manufacturer indicated that their formulating tanks would be dedicated to COVID-19 vaccine production based on market requirements. Final output includes these as being available for COVID-19 vaccine production.
Fig. 4
Fig. 4
A. Filling capacity (measured in tubes or vials per minute) for each of the specified filling technologies. Capacities were quantified in each WHO region. Note: not all manufacturers who indicated they utilize the filling technology shared their specific capacity. Any responses to this question that were not in correct units were omitted from the final output. The breakdown of the omitted data for each filling technology is: Glass vials: one manufacturer did not indicate filling capacity. In instances in which filling capacity was provided as a range e.g. 100–200 vials/minute, the lower value was always used in the final output. Fig. 4B. Total number of manufacturing lines and the percentage of which could be dedicated to COVID-19 vaccine manufacturing. Across all filling technologies sampled manufacturers have 85 manufacturing lines of which 49 could be dedicated to COVID-19 vaccines (57.6%). Note: four manufacturers indicated that their manufacturing lines would be dedicated to COVID-19 vaccine production based on market requirements. Final output includes these manufacturing lines as being available for COVID-19 vaccine production.
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