Monoclonal Antibody Expression in Fast Alternative Hosts: Demonstration & Reference Material

The overall goal of this project is to assess the readiness of a yeast currently used to produce commercial therapeutic monoclonal antibody for rapid responses to pandemic situations.

Industry Need

Identifying monoclonal antibodies (mAbs) from convalescent patients for pathogens like coronaviruses is efficient and fast today, requiring only 1-3 weeks from initial discovery to selection of lead candidates for therapeutic use.
In contrast, the expected typical timelines to manufacture these proteins using mammalian cells for initial clinical studies is about 5-6 months.
Reducing the time required to achieve the first quantities of such mAbs for emergency use could allow for faster responses to emerging pathogens.

Solution

Using alternative cell types, such as yeast, could reduce mAb production time from 5-6 months to 2-3 months. MIT studied the readiness of a yeast currently used to produce commercial therapeutic monoclonal antibody for rapid responses to pandemic situations.

Steps of the project included:

Cloning of antibody sequences into a set of engineered yeast strains
Evaluation of production in batch cultivation and small-scale fermentation
Generation of small batches of purified proteins for analytical assessments on quality

Outcomes and Impacts

Proof-of-concept data from this study for sustained continuous production of recombinant protein using yeast provides support for next‐generation manufacturing strategies for fast, efficient production of recombinant proteins that may enable improved equitable access and affordability of medicines in the United States and globally, including mAbs and other recombinant protein products such as insulin.

Established reference cells and materials to guide additional development for fast efficient production of Mabs in a yeast organism that could enhance capabilities for pandemic responses.

Informed an alternative manufacturing solutions for on-going responses to protect from COVID-19 or other emerging pathogens.

Directly advanced the biotechnologies that enable small‐footprint biomanufacturing of proteins.

Updates, Related Publications, and Deliverables

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Project Lead

Massachusetts Institute of Technology