MJFF Partnership to Supply Large Quantities of Monomeric Recombinant α-Synuclein

Real-time quaking-induced conversion (RT-QuIC) assays

Real-time quaking-induced conversion (RT-QuIC) assays have shown promise in early diagnosis of diseases such as Parkinson’s, multiple system atrophy and dementia with Lewy bodies.

The importance of this ability cannot be understated.  As therapies to slow or halt disease are in development, early diagnosis could mean early treatment and improved quality of life for the patient.

The RT-QuIC assays detect misfolded forms of the protein α-synuclein (αSyn) in patient biosamples. The levels of misfolded forms of αSyn are associated with, and therefore are indicators of, these neurological diseases.

The key reagent in the RT-QuIC assay is recombinant αSyn protein, which is in a monomeric form and acts as a substrate in the assay, forming fibrils when misfolded αSyn is present.

What is desperately needed by the scientific community is a common, large supply of monomeric recombinant αSyn to increase the consistency and quality of the data that is produced in RT-QuIC assays by different research teams using the same key reagent.

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) Partnership

To address this need, The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has coordinated a partnership, with the depth of knowledge, experience and diverse skills required for this challenge.

The teams including Peak Proteins Limited and the Centre for Process Innovation are responsible for modifying and scaling up the current lab-scale production process for αSyn to full manufacturing scale, along with developing the quality control assays that are required to support this effort.

Dr. Alison Green and her team from the Centre for Clinical Brain Sciences at the University of Edinburgh have expertise in the RT-QuIC assay and will confirm that the recombinant αSyn produced is fit for purpose. MJFF is providing financial support and overall project management.

Nicole K. Polinski, PhD, Director of Research Programs at MJFF, said: “Obtaining large quantities of recombinant monomeric αSyn protein that is suitable for the RT-QuIC assay has presented a barrier to adoption of this important assay. The technical developments from Peak Proteins, manufacturing at CPI, and protein validation from the Green lab will no doubt help accelerate biomarker and therapeutic progress for Parkinson’s disease.”