Hitendra Kansagra

Hitendra Kansagra comes with over 15 years of experience in upstream process in bio-pharmaceutical industry. His expertise lies in overall cell line selection, media/feed development, process development/optimization/characterization, MSAT, bio-manufacturing operations, process scale up, global tech transfer, single use technologies, CMC, capital expansion, facility design & commissioning, process and cleaning validation, equipment procurement and qualifications, QMS documentation, team management, recruitment and audit compliance of global scale commercial products operations.
Hitendra has hands on experience and management experience in concept design, assessment, procurement and installation of diverse bioreactor/fermenter scale in glass, single use and stainless steel (250mL, 2L, 5L, 10L, 50L, 250L, 500L, 1000L, 2000L and 5000L). Have worked with industry leading bioreactor/fermenter manufacturing like sartorius, thermo, eppendorf, merck, applikon, finnese, bioengineering, cytiva, GE, OmniBrx etc.
Hitendra has experience working with different biologics modalities like monoclonal antibodies, recombinant proteins, ADCs, cell and gene therapy, immunosuppression, plasmid DNA, mRNA, fusion proteins, viral vectors & vaccines (AAV, MVA, Adenovirus, Lentivirus, CMV, Baculovirus) and Microbial (E. Coli, Listeria), Yeast ( S. Cerevisiae), Insect (SF9, High Five), Human (MRC5, Hela, A549, HEK293), Mammalian (CHO,NS0, SP2.0), Stem cells, Avian ( EB66, CEF, AGE1).
He has partnered and worked with USFDA, EMA, TGA, ANVISA, Health Canada and other regulated market approved facility for biosimilars/biologics manufacturing. Hitendra is currently employed at APC Ltd (CRO/CDMO) since August 2021 as Biologics (Upstream) Technical Lead. Previously, Hitendra was the Head of Upstream Biosimilar Manufacturing Operations at Nobel Ilac A.S before that Hitendra was Team Lead, Upstream Biosimilar/Biologics Manufacturing Operations at Biocon Limited. Hitendra held this role for 4 years (April 2015 – March 2019) and was responsible for Bio-manufacturing operations & trouble shooting, QMS, process design, scale-up, global tech transfer, capital expansion and validation/qualification. He also served as a SME in KGI-Biocon Biosciences program for 8 consecutive batches. Prior to this, Hitendra held the position of Senior Executive, Upstream Biosimilar Manufacturing Operations, while working at Syngene International Limited. Hitendra occupied this position for 23 months (December 2012 – November 2014). Previously, Hitendra held the position of Executive, Upstream Biosimilar Manufacturing, while working at Cadila Healthcare Limited. Hitendra held this role for 4 years (June 2009 – December 2012).
Before this, Hitendra held the position of Microbiologist, while working at CTX Life Sciences Pvt. Ltd.. Hitendra occupied this position for 17 months (December 2007 – May 2009). Hitendra completed a Master’s degree in Biotechnology from Barkatullah University, in 2007. Additionally, Hitendra received a B.Sc in Microbiology, in 2004, from Veer Narmad South Gujarat University.