The challenge of protein production for therapeutic R&D and commercial manufacturing
In R&D, protein production can present many obstacles:
- Inability to produce “difficult-to-express” protein.
- Inability to produce needed protein in sufficient quantity.
- Cost of protein production contributes to the high cost of biologics.
- Cost of biosimilars difficult to contain due to the cost of protein production.
Primary Cause: Protein Folding/Intracellular Quality Control System
Although the structure of a protein is ultimately essential for its biological function, researches over the last few decades have revealed that many proteins expressed in a cell have a problem with their structure. Proteins with an aberrant structure (misfolded or unfolded peptide) do not only lose their activity but are also toxic to cells (oligomer, polymer or aggregation of aberrant proteins). Therefore, human cells have developed machinery to monitor such abnormal proteins (cellular quality control system). This cellular quality control system has a huge impact on secreted proteins since these proteins are embedded in the endoplasmic reticulum (ER) soon after the RNA is translated into the peptide. The cellular quality control system in ER regulates secretion of secreted proteins to prevent the diffusion of such an unwelcome effect systematically.
Our Solution: TapBoost® Technology for protein production
SOLA Biosciences has developed a novel technology called TapBoost, which assists proper protein folding and cellular quality control systems specifically for a targeted protein.
A proprietary protein (TapBoost protein) is expressed together with a therapeutic protein (targeted protein). The “TapBoost protein” consists of two functional domains, the Effector Sequence (TapBoost sequence: TBS) is an engineered protein domain based on a naturally occurring chaperone molecule that has been modified to enhance folding and secretion of bound proteins within the ER and the Target protein binding domain (TPBD) for protein targeting. TBS was identified by SOLA using a proprietary algorithm, an intensive search for specific amino acid sequences involved in protein folding, and intracellular quality control systems. The TapBoost protein binds its targeted protein through the TPBD, resulting in enhanced production of the targeted protein.