The Coalition for Epidemic Preparedness Innovations (CEPI) called for a $2BN fund to be set up to support SARS-CoV-2 vaccine development and global manufacturing capacity expansion in March1. As part of the plan, the organization is mapping capacity and building a facility database to understand what exists globally.

A CEPI spokesperson said, “We are looking for additional facilities to duplicate manufacturing processes in multiple countries to distribute supply around the world. We have a database of more than 200 biological manufacturing organizations and/or fill/finish organizations that we have created for this potential need. A significant number of these already have licensed products or are approved through the World Health Organization (WHO) pre-qualification, which improves the probability of success and supports global distribution.”

But even with existing capacity we will require new plants. “If we need to manufacture billions of doses there will have to be additional manufacturing capacity,” added the spokesperson.

The idea is to establish a reactive network of facilities able to make vaccine when needed. Operating the network requires careful planning, according to CEPI.

“This is a 100-year event and preparing for such is challenging. Capacity could go largely unused for many years and, if it is not used routinely, it is not really ready to respond rapidly. If it is kept busy with other products, it is not available for an outbreak response,” continued the CEPI official. “It is a challenging situation to truly prepare for, but this pandemic will be a strong and lasting memory for all of us and this memory will hopefully support greater investment and diligence in the future.”

Single-use supply chains

CEPI has selected plants based on their manufacturing capacity and flexibility.

“Single-use technologies will be widely used in our response,” pointed out the spokesperson. “The benefit is that cleaning validation for new products in a facility is greatly reduced when single-use disposable bioreactors, filters, and columns are used.”

Basing a pandemic response on single-use systems will involve working with all stakeholders, including the technology sector.

“There are some supply chain concerns with single-use equipment as the biopharma and gene therapy industries are fast growing and consuming much of the capacity for the single-use bioreactor bags,” continued the official. “Before COVID, backorders for these bioreactor bags were about four months. We are working with suppliers to improve availability for this rapid expansion for COVID.”

Vaccine plants that use stainless steel systems are also part of CEPI’s plan, but these also present some challenges, said the CEPI spokesperson. “Fixed equipment will not have this supply chain risk, but will have the added burden of cleaning, validation, and generally longer turn-around time between batches for somewhat reduced efficiency,” he noted, adding that CEPI is also supporting the development of rapid response vaccine manufacturing platforms.

“Our rapid response platforms include a number of RNA- and DNA-based vaccines, which can be produced quickly. There are also a couple of subunit protein approaches that are platform-based so the process does not have to be developed ‘from scratch’ for each product, but only needs fine tuning of operating conditions. We are working with technology developers to upscale some of the processes and to secure supply of single-use equipment and resins. When current technologies do not support rapid response, we will innovate and test new technologies. We are studying some novel filling technologies as we expect limitations in filling capacity as well as a shortage of glass vials due to the unusually high demand for vaccine.”

 

Reference
1. $2 billion required to develop a vaccine against the COVID-19 virus.

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