In the realm of global health, cost is often the linchpin in access to life-saving medications and vaccines, especially in low and middle-income countries (LMIC). For years, the availability and price of recombinant albumin, a key ingredient for vaccine manufacturing, have posed a significant challenge to affordable vaccine production. This is where biotech company Phenotypeca, with support from the Bill & Melinda Gates Foundation, an entity renowned for its commitment to equitable healthcare, comes into play.
The limited availability and high cost of recombinant albumin are critical roadblocks to producing affordable vaccines for children in LMICs. The current market dynamics are such that recombinant proteins are sold to premium markets at high prices. Suppliers that control the manufacturing process keep their know-how tightly protected, making it hard for other entities to produce or procure the necessary resources at lower costs.
Phenotypeca’s goal, supported by the Gates Foundation, was to optimise strains of Saccharomyces cerevisiae (a species of yeast) to manufacture recombinant albumin for LMIC vaccines. The project's crux lay in producing high-quality albumin at a commercial scale, ensuring maximum net yield and, thus, significantly reducing supply costs.
The first phase of the project witnessed a thorough characterisation of the desired high-quality albumin, with Phenotypeca successfully establishing strains secreting recombinant albumin. State-of-the-art high-sensitivity mass spectrometry was employed to analyse the secreted albumin, confirming its quality and alignment with predefined characterisation parameters.
For creating a diverse library of strains, Phenotypeca sourced initial parent strains from various geological and ecological niches worldwide. Strains were then meticulously screened for their albumin secretion capabilities. Following successful screening, optimisation was pursued to achieve initial yield targets for commercial-scale manufacture.
The project is currently focusing on iterative Quantitative Trait Loci (QTL) optimisation. This technique's application will increase the yield further and streamline downstream processing, thereby lowering the cost of manufacturing recombinant albumin for LMIC vaccines even more.
Alongside these scientific endeavours, Phenotypeca has support from the foundation to identify suitable manufacturing partners. This effort aims to establish the resultant process on a larger scale and produce commercial quantities of albumin. The primary focus will be its incorporation in LMIC vaccines, with Measles and Rubella vaccines as the starting point.
This project underscores the power of collaborations in advancing global health. By addressing the challenge of recombinant albumin availability and pricing, Phenotypeca is seeking to provide a critical component toward the goal of no child in any country being deprived of essential vaccines due to cost constraints.
“This project has paved the way for us to develop our platform and strive to achieve our mission statement – to increase access to medicines for underserved demographics worldwide, and to make treatments more affordable,” says Johnny Cordiner, CEO.