Since the end of the 1990’s, the pharmaceutical industry has seen an increased interest in biologics, especially in the therapeutic areas of oncology and inflammation. Here we present the automation of two assays for the characterization and selection of potent antibody drug candidates. Both assays rely on HTRF® detection. The first assay quantifies the binding affinity of antibodies to their target antigen, on live cells.

TNFa blocker biopharmaceuticals represent an important and successful class of protein drugs used in the treatment of several autoimmune diseases. Bioassays are indispensible tools in biopharmaceutical drug development and commercialization that are used to quantify biological activity and stability of drugs or drug candidates. The automation of these assays can serve to create an accurate, robust process which can allow the researcher to perform other more important functions.

Assays that can assess the ability of a biosimilar to act in a manner similar to the original biologic have seen increased interest. This poster describes the use of a non-radioactive luminescent chemistry to simplify the assay process and provide improved data quality.

Objectives of this project were to exploit the database in indian setting to determine nuclear antigens as target for antinuclear antibodies (ANA) in patients of autoimmune hapatitis (AIH) type1.

Suggestions are provided of how efficient industrial bioprocessing can be accomplished, independently of highly expensive molecular biology approaches, in order to recover natural products of medicinal value from wild plant species.

Umbilical cord blood (UCB) has recently been the focus of clinical applications. UCB contains of hematopoietic stem cells and mesenchymal stem cells (MSC). Clinical studies shows that MSC can be used in regenerative medicine hereby treatment of cardiac diseases. The aim of this project is to establish a protocol for isolation of MSCs from frozen UCB. This study demonstrated that it’s possible to expand MSC.

The conventional antibody screening assay based on antibody-antigen binding has been enzyme-linked immunosorbent assay (ELISA). While tedious and consuming, ELISA has proved sufficient for the identification of antibodies directed against secreted antigens. However, cell surface antigens (e.g. GPCRs) provide challenges for ELISA due to the shortage of soluble antigens and high variability resulting from loss of cells during wash procedures.

Much attention has been given to ion exchange (IEX) media as a means to improve productivity as a result of increasing demand for higher efficiency on the downstream process. Until recently, strain optimisation for high productivity and upstream purification were the bottlenecks for most bio-processes.

Escherichia coli (E. coli) has been commonly used for the production of biopharmaceuticals. Among the impurities that must be monitored in biopharmaceuticals is residual host-cell DNA (HCD). This study describes the development and subsequent NDA-level validation of a real time PCR procedure developed in response to a client’s need to improve the sensitivity of detection and quantification of residual E. coli HCD in their drug product.

According to the BBMRI (Biobanking and Biomolecular Resources Research Infrastructure) about 8,000,000 formalin-fixed paraffin-embedded (FFPE) samples derived from a multitude of different diseases have been collected in medical centers and biobanks all over Europe during the last decades.