Theragen Biologics : Chennai based start-up biologics company established in the year 2017

Scientific Collaborators

Dr. Jason Moffat

Dr. Moffat joined the Donnelly Centre in 2007 after a postdoctoral fellowship at the Whitehead and Broad Institutes where he helped to develop the first lentiviral RNA interference libraries for systematic perturbation of all human and mouse genes. The Moffat lab is broadly interested in the regulation of cell growth and proliferation in cancer cells and has been developing genetic tools to identify genes encoding cancer cell surface proteins important for cellular fitness and cellular state. Together with the Sidhu lab, the Moffat lab is also developing new methods and technologies for the identification of synthetic antibody reagents against cell surface molecules that could be used as research tools for exploring protein structure and function.

Dr. Frederic Fellouse

Dr. Frederic Fellouse, researcher affiliated with Dr. Sachdev Sidhu’s laboratory at the University of Toronto, has a pharmacy and bioengineering background. His PhD work conducted at Genentech and the University of Provence, allowed the development of highly functional synthetic antibody repertoires surpassing the functionality of the natural immune system. This new generation of biologics enables quick and low-cost discovery of high performance reagents, therapeutics and diagnostics. As a postdoctoral fellow at the Lunenfeld Research Institute in Professor Wrana and Pawson, Dr. Fellouse developed synthetic antibodies as reagents to explore cell signalling. Dr. Fellouse now leads a protein engineering research program as well as the development of therapeutic and diagnostic antibodies to treat cancer, eye diseases and infectious diseases. In the area of infectious diseases, Dr. Fellouse’s current interests are around Dengue fever treatments and diagnostics and the improvement of a vaccine for cattle East Coast fever.

Departments

Upstream Department

Upstream, the term in itself describes the process of initial stages of exploration and production. As it is Upstream department primarily focuses on the selection of engineered clones through High-Through put screening technologies, generation of cell banks (MCB and WCB) and it’s characterization following the ICH guidelines, development of cost effective media for the expression of protein in small scale and large scale.

The whole process can be subdivided into Selection of suitable strain, Isolation of Plasmid, Transformation, media development and optimization, optimization of growth and expression kinetics, inoculum development, improvement of inoculum by genetic engineering process, scale-up of the process in fermenter from 16L to 50L fermenter its optimization and generation of biomass. Industrial strain improvement to enhance productivity and maintenance of strain purity can be attributed as the secondary focus.

The team comprises of promising, passionate and qualified professionals (M.Tech/M.Sc, Ph.D & PDF) who are expertly trained in diverse fields and dedicates themselves to the researches which aids in the improvement and troubleshooting of all the in-process related challenges.

The department is equipped with highly sophisticated equipment’s from leading enterprises across the globe viz., Bioengineering, Eppendorf, Thermofisher Scientific, YSI, Orbitek, Sthiraa, Nutech, Heal Force, Ragha, Mettler Toledo, Biorad and the like.

Downstream Processing Lab

Downstream Processing (DSP) Lab is one of four well-established labs at Theragen Biologics. It is well-equipped with advanced equipment necessary for downstream processing of biologics development.

In DSP lab, we are involved in the three stages of downstream processing. The three stages are - (1) Release of Intracellular Products (2) Concentration and (3) Purification by Chromatography.

Our DSP lab is well-equipped with state of the art to process and purify biologic drug. We have High pressure homogenizer (GEA, Italy), Tangential Flow Filtration System (Pall, USA), AKTA Pure (GE, Sweden), Electrophoretic Apparatus, Semi-dry Western Blot, Vacuum Pump, Magnetic Stirrer with hot plate, Spinwin, Gel Rocker, voretx etc.

The team members of DSP lab are well-educated, experienced and dedicated scientists who are constantly working towards the process development and purification of quality biologic product with immediate trouble-shooting capabilities.

"Downstream processing department is allied with formulation laboratory specialized for the development of intra vitreal formulation. The primary goal of the department is to develop novel stable formulation for biologics. With the state of art facility in biopharmaceutical development combined with a well trained work force, the laboratory is equipped with calibrated osmometer, lab scale TFF unit, calibrated pH and conductivity meters"

Bioanalytical Department

Bioanalytical department is involved in method development, assay validation and sample analysis for characterizing novel biologics. The team supports Upstream, Downstream and Formulation department by analyzing and comprehending the routine in-process samples as well as comprehensive quality evaluation of protein expression profiles clones as part of high through put screening drug substances/ drug product. Bioanalytical team conducts various assays for with respect to quantification, affinity determination, stability profile analysis and characterization of process- and product- related impurities like HCP, Endotoxins, HCDNA etc.

Bio-analytical department has a dedicated team of researchers with significant experience & technical expertise in performing ELISA based Assays, HPLC and cell based assays.

Various techniques employed by Bioanalytical lab includes :

• RP- UPLC

• SEC- UPLC

• SDS-PAGE, Native PAGE

• Sterility testing

• Residual host cell DNA analysis

• Host cell proteins analysis

• Qualitative and Quantitative Immunoassays

• Chromogenic Endotoxin Assay

• Leachate estimation for resin ligands

• Epitope Mapping

• Cell based assays

The facility is equipped with HPLC systems, BioTek synergy multimode plate reader, ELISA plate washers, incubator shaker and animal cell culture facilities.

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