lino Biotech´s Expertise for Your Applications

Affinity Ranking

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).

Affinity Ranking Assay developed by lino Biotech
The Glycan Analysis Array developed by lino Biotech

End Product 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. 

Nanoparticle Analysis

Identity Multiplex Array

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.

Nanoparticle Analysis

Purity Check Kit

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.

Potency Assessment Kit

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.

Biosensors applications

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.

We offer contract research. Interested for more?

Frequently asked questions

Biosensors are the analytical device that detects changes in biological approaches and there are a lot of biosensors applications possible. Focal Molography is a biosensor platform, which combines several assays into one platform and measurements independently of environmental noise are possible. Therefore, it can be used perfectly for biosensors applications for the bioprocessing, diagnostics and cell and gene therapy.

With different biosensors applications, it is possible to measure different assay parameters. With these novel analytical tools lino Biotechs focuses on applications in bioprocessing, drug screening and cell- and gene therapy sector for biosensors applications.

Biosensors applications can provide cost-effective measurements, are easy-to-use and highly accurate detection devices. lino Biotech´s focal Molography provides multidimensional data to characterize biological interactions in living cells and the company has a lot of possible biosensors applications in their product portfolio.

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