Focal Molography Solution for Cell and Gene Therapy - Medical / Health Care - Pharmaceuticals
Simple and robust determination of critical quality attributes in bioprocess.
Purpose of the Assay
Developing and manufacturing biopharmaceuticals, in particular therapeutic proteins, is a difficult and non-straightforward process. It starts with the research for a therapeutic protein (e.g a monoclonal antibody, mAB) that binds to the desired target and the identification of the gene sequence that encodes for this protein. Once this completed a suitable cell line for manufacturing must be identified. Both steps can be a challenging and lengthy process. The Affinity Ranking Assay developed by lino Biotech aims to facilitate this process, both in the binder screening (step 1) and in the cell line selection (step 2).
Quality Control
The Glycan Analysis Array to be developed by lino Biotech aims to identify and quantify glycosylated proteins such as mABs in biopharmaceutical manufacturing.
Process of the Assay
Glycosylation is the attachment of glycans to a functional group in proteins and is crucial for protein folding, stability, and adhesion between cells. In biopharmaceuticals, protein glycosylation is essential for proper function in that it greatly affects pharmacokinetics and half-life of the drug in patients. The figure below illustrates an example of protein glycosylation on asparagine residues within the ER (Enduplasmic Reticulum) of a human cell. The oligosaccharide, consisting of N-acetyl glucosamine, mannose and glucose, is transferred from dolichol to the asparagine residue of the protein. Then, three residues of glucose and one mannose residue are removed.
Product Concept Overview
The identity multiplex array is a test for verification of the identity and the integrity of nanocarriers. In the context of cell-based therapies and vaccines, which are the focus of lino Biotech‘s technology, identity testing consists of identifying both molecular components of the nanocarriers (viral vectors/LNPs) as well their respective payloads to ensure integrity of the product.
Product Concept Oveview
The purity check assay detects sample contaminants stemming from manufacturing process of cell- based therapies and vaccines. The purity assay will allow customers to adjust their production process for minimal formation of contaminants during the process by identifying potential contaminantions early. The purity assays to be developed by lino Biotech will target bacterial, viral, and fungal contaminations, as well as impurities caused by the cell culture itself such as HCPs and nucleic impurities.
Product Concept Overview
The potency assessment kit aims to test “the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result.” ((FDA), 2011). In other words, the potency assessment must measure two outcomes:
- the status of genetic material transfer
- the biological effect of the transferred genetic material
The potency assessment kit to be developed by lino Biotech focuses on potency assessment for both cell & gene therapy (CGTs) and vaccine manufacturing. To this end, it performs three tests:
quantification of antigen expression; quantification of immunogenic viral protein epitopes in the manufactured product for viral vectors to determine physical titer; Quantification of functional proteins released by cells, e.g. cytokines, to determine effector functions of cell-based therapies.
There are numerous possible biosensors applications. In general, a biosensor is an analytical device that detects changes in biological processes and converts them into an electrical signal. The term biological process can be any biological element or material like enzymes, tissues, microorganisms, cells, acids, etc. In our term, it can ne stated as device that uses specific biochemical reactions mediated by isolated enzymes, immunosystems, tissues, organelles or whole cells to detect chemical compounds. Put simply, this means that a biosensor utilizes molecular interactions from or based on those in living systems to detect a compound of interest. The main area of interest of biosensor is the Medicine, Clinical and Diagnostics applications. lino Biotech focuses on the bioprocessing, drug screening and cell- and gene therapy sector for biosensors applications.
Biosensors applications aim to improve the quality of life. Developing and manufacturing biopharmaceuticals, in particular therapeutic proteins, is a difficult and non-straightforward process. It starts with the research for a therapeutic protein (e.g a monoclonal antibody, mAB) that binds to the desired target and the identification of the gene sequence that encodes for this protein. Once this completed a suitable cell line for manufacturing must be identified.
Both steps can be a challenging and lengthy process. The Affinity Ranking Assay as one of many biosensors applications developed by lino Biotech aims to facilitate this process, both in the binder screening and in the cell line selection.
Another possible biosensors application is the Glycan Analysis Arrary, aiming to identifiy and quantify glycosylated proteins such as mABs in biopharmaceutical manufacturing. Glycosylation is the attachment of glycans to a functional group in proteins and is crucial for protein folding, stability, and adhesion between cells. Biosensors Applications in biopharmaceuticals, such as the glycosylation, is essential for proper function in that it greatly affects pharmacokinetics and half-life of the drug in patients.
Another biosensors applications is the nanoparticle analysis. The aim is to identity multiplex arrays and lino Biotech has expertise and products for that in its product portfolio. Three different steps belong to that process. The identity multiplex array is a test for verification of the identity and the integrity of nanocarriers. In the context of cell-based therapies and vaccines, which are the focus of lino Biotech‘s technology, identity testing consists of identifying both molecular components of the nanocarriers (viral vectors/LNPs) as well their respective payloads to ensure integrity of the product. The purity check assay detects sample contaminants stemming from manufacturing process of cell- based therapies and vaccines. The purity assay will allow customers to adjust their production process for minimal formation of contaminants during the process by identifying potential contaminantions early. The purity assays to be developed by lino Biotech will target bacterial, viral, and fungal contaminations, as well as impurities caused by the cell culture itself such as HCPs and nucleic impurities. The potency assessment kit to be developed by lino Biotech focuses on potency assessment for both cell & gene therapy (CGTs) and vaccine manufacturing. To this end, it performs three tests: quantification of antigen expression; quantification of immunogenic viral protein epitopes in the manufactured product for viral vectors to determine physical titer; Quantification of functional proteins released by cells, e.g. cytokines, to determine effector functions of cell-based therapies.