Zumutor’s product development team has proven track record in process engineering in Biosimilar product development. The team has extensive experience in taking biologics through various stages of regulatory approval for domestic and international partners. We follow QbD approach for process development of biosimilars. Our philosophy is to develop “highly similar” biosimilar product using “Totality of Evidence” approach for developed and emerging markets. Our QTPP is established using several different batches of innovator’s molecule. We have capabilities for developing biosimilar using both microbial and mammalian platform. We carry out extensive physico-chemical, structural and functional analysis of proposed biosimilar following global regulatory standard

Zumutor’s Biosimilar product

Proposed biosimilar to Exendin-4 and Trastuzumab using microbial and mammalian cell line, respectively have been developed. Exendin 4 (marketed as Byetta®), a GLP1 analog is prescribed for twice a day injection for diabetics. The proposed biosimilar product has been extensively characterized to establish biosimilarity and is ready for pre-clinical studies – animal toxicity and pharmacokinetics studies

Trastuzumab is a recombinant humanized IgG1 monoclonal antibody that binds specifically to extracellular domain of human epidermal growth factor receptor 2 (HER2); indicated for adjuvant treatment of HER2-overexpressing breast cancer. After extensive process development and characterization, this molecule is ready for animal studies. In vivo efficacy study of proposed biosimilar to Trastuzumab in PDX Model has been successfully completed