Usv Private Limited

Uma Sankararaman

Rakesh Shekhawat

Shrikant Mishra

Dipanwita Maiti

Anjali Chutke

Gulnaz Zaidi

Priti Thakur

Narasimha Kumar Kopparapu

Bipinchandra Rathod

Meera Sankarankutty

Niren Praful Thakar

The present invention discloses a process for the preparation of rhPTH (1-34) also known as teriparatide by construction of a novel nucleotide, as an NcoI.IXhoI fragment as set forth in SEQ. ID. No.:1 encoding a chimeric fusion protein as set forth in SEQ.ID. No.:2 comprising of a fusion partner consisting of 41 amino acids belonging to&#x3b2;-galactosidase (LacZ) gene, an endopeptidase cleavage site, rhPTH (1-34) gene fragment, cloning the said nucleotide in an expression vector under the control of T7 promoter, transformingwith the said vector and expressing the chimeric fusion protein in fed batch fermentation. The present invention further discloses a low feed rate lactose induction for optimized expression of rhPTH (1-34) in. The present invention also discloses an unique, novel two step orthogonal purification process for rhPTH (1-34) comprising of cation exchange chromatography optionally followed by preparative chromatography selected from HIC or RP-HPLC to yield a target protein of &#x2267;99% purity. The present invention discloses a simple, cost-effective, environmentally benign method of producing high purity rhPTH (1-34).

Orthogonal process for purification of recombinant human parathyroid hormone (rhPTH) (1-34)

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Navi Mumbai, India

Uma Sankararaman