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Manufacturing capability

CELT is developing an open access resource to address the current absence of information to developers of long-acting therapeutic products for low- and middle- income country (LMIC) markets.

Project overview

Long-acting therapeutics have the potential to revolutionise the treatment of chronic illnesses by addressing key weaknesses in current regimens, such as high pill burden and poor patient adherence. These challenges are particularly pronounced in LMICs, where diseases like tuberculosis and hepatitis C virus remain widespread. By enabling local manufacture, long-acting therapeutics could potentially help LMICs improve access to care.

However, the promising approach of long-acting therapeutics comes with significant hurdles. As a relatively new technology, long-acting therapeutics are unfamiliar to many contract manufacturing organisations, which may lack a clear understanding of the specific requirements for their development and production. Furthermore, even though many organisations use manufacturing techniques and equipment that could be adapted, they may not currently possess all the necessary facilities or specialised tools for large-scale manufacture.

These gaps highlight the need for a comprehensive assessment of global long-acting therapeutic manufacturing capacity, with particular attention to LMICs. To address this, a network of stakeholders with potential manufacturing capabilities will be established. Mapping their capabilities will provide a valuable tool for developers of long-acting therapeutics, enabling them to identify and select the most suitable manufacturing partners for a given product and target market.

Objectives

The overall goal is to facilitate development and manufacture of long-acting therapeutics globally with a focus on LMICs. This will mean streamlining the process of identifying and selecting a contract manufacturing organisation for a given product by:

  • Assessing current contract manufacturing organisation capability with a focus on LMICs
  • Identifying and engaging with stakeholders who have potential capabilities of manufacturing long-acting therapeutics
  • Establishing and launching an open access web resource for developers of long-acting therapeutics.

Awarding body

This work is supported by global health agency Unitaid.

The Unitaid logo is the organisation name written above the words

 

 

 

 

(2020-38-LONGEVITY)