SYNOPSIS

Twelve years of experience in Downstream Process Development. Biotherapeutic protein production development in Oncology, Diabetes, Osteoporosis, Metabolic Disorder, Neuropathic pain, Inflammation, Rheumatoid arthritis, lung cancer,lymphoma.

Involved in the development of various Biosimilars, Innovators, Biobetters, other Protein molecules like Receptors, ligands as target antigens.

Experience in mammalian cell culture, Shake flask protein expression in bacterial cells, Insect cell lines

& Mammalian cell lines

Expertise in Downstream processing of various proteins from various hosts like E.coli (BL21 (DE3) & K12 Derivatives) Mammalian cell lines (CHO, HEK293), Insect cell lines (Sf9,Hi5,Sf21)

Technology Transfer for various biosimilars & innovators. Expertise in protein analysis & characterization, High Throughput protein expression & Resin Screening

Efficient Project management with lots of innovative ideas to develop new process without compromising product quality & quantity and keeping better process time & cost effective process

Involved in proposal for new targets, off-targets along with CADD & Molecular biology team

Strong analytical and organizational abilities. Possess a flexible and detail oriented attitude with an innovative bent of mind

CORE COMPETENCIES

Biosimilar/Recombinant

Proteins (Microbial)

IFN α2b (Interferon), gCSF (Granulocyte Colony Stimulating Factor),Parathyroid Hormone

(PTH), Ranibizumab/Lucentis, recombinant Exenatide, Recombinant Kinases, Receptors Biosimilar (Mammalian) Trastuzumab (Anti HER2/neu receptor), Rituximab (Anti-CD20), Bevacizumab (Anti VEGF-A) Cell Lines Maintained MT-2, SubT1,U 323, MDCK, CHO cell lines, HEK 293, GHOST cells, PBMCs, (Mammalian cells). Sf9, Hi5, Sf21(Insect cells)

Innovators & Targets Ulocuplumab -CXCR4,Urelumab- AntiCD137, Lirilumab - Anti KIR, Anti PD L1, Anti LAG3, Anti Leukemic BsAb, Kappa Light chain & Lambda Heavy chain - Various Cancer, Anti fucosyl GM1,Trastuzumab biobetter,Targets : Diabetes & Met. Disorder, R. arthritis, Osteoporosis, Melanoma, NSCLC.

Protein Expression

(Shake flask 8 -20 L)

E.coli - BL21 (DE3), BL21 (DE3) p Lys S, Origami II (DE3), Rosetta II (DE3), Rosetta Gami II (DE3), C 41 (DE3), C43 (DE3), C43 (DE3) pLys S, BL21 Codon Plus Mammalian cell lines - CHO, HEK293 6E & Insect cell lines - Sf9, Hi5, Sf21 Protein Purification

Techniques

Cell lysis – Sonication, HP Homogenization, Freeze Thawing, High Temperature Chromatography - HTS of Resin, Column Packing & Evaluation, Various Chromatography: Affinity, IEX, HIC,MMC, SEC, RPC.

Clarification - TFF (MF), Depth Filtration, Centrifugation Inclusion bodies: IB Isolation, Clarification, IB Solubilization, Protein Refolding by various methods

FPLC System - AKTA series – Prime Plus, Explorer, Purifier, Pure, Bio-Rad NGC-II system Filtration : Lab Scale TFF system-Millipore,Minimate -Pall, Depth filtration modules (Pall, Millipore, 3M, Sartorius) Virus Filtration (Viresolve, Planova filters) Construct Designing As part of Innovator Product development, Off-target constructs designed along with CADD & Protein Structure Refinement Team

Protein Analysis &

Characterization

SDS-PAGE, Spectrophotometric Protein Estimation, Western blotting, IEF, Thermal Shift Analysis (TSA), SPR (Biacore) Dynamic Light Scattering (DLS), ITC (Isothermal Colorimetry -iTC) Softwares Windows 8.1, XP, MS Office 2010, Adobe Photoshop, Unicorn series, Picasa-3, Windows Movie Maker, Spectra, ERP,LDMS

Vivek Halan Phone: +91-966*******

Bangalore, India E-mail: acxun3@r.postjobfree.com

Vivek Halan Phone: +91-966*******

Bangalore, India. E-mail: acxun3@r.postjobfree.com

ACADEMICS

Master of Science in Biotechnology from Department of Biotechnology, Bharathidasan University, Tamilnadu, India, 2002-2004 (Average Marks Percentage: 76.90 %)

Bachelor of Science in Microbiology from KSR College of Arts & Sciences, Periyar University, Tamilnadu, India, 1999-2002 (Average Marks Percentage: 75%) PROFESSIONAL EXPERIENCE

Organization: Zumutor Biologics Pvt Ltd (Theramyt Novobiologics Pvt Ltd), Bangalore Designation: Senior Scientist - Downstream Process Development, Duration: March 2014 to till date

Heading Downstream Process Development for various mAbs, Microbial Biosimilars, Innovators

Designing the Downstream Process for Biosimilars & NBEs

Successfully submitted a dossier for a Innovator molecule(Recombinant Exenatide) to RCGM

Process development for Bevacizumab (Anti VEGF-A receptor) & Trastuzumab from CHO cells, Innovator molecule and one biosimilar from E.coli

Proposed Detailed Product Development Plan (PDP) for a Biosimilar from CHO cells and E.coli

Process development for afucosylated Trastuzumab (Biobetter) from CHO cells

BPR Document Preparation, Resin Life Cycle study, Technology Transfer Document(TTD) Preparation & Review all Downstream Process related documents Organization: Biocon Bristol Myers (BMS,USA) Research Centre (BBRC)/ (Biocon Group), Bangalore Designation: Research Scientist, Duration: April 2009 to February 2014

Full time working for Bristol Myers Squibb (BMS), USA & Biocon (India) projects. mAbs Expression in CHO cell system & HEK293 cell system in 6- 8 Lit scale & CHO Stable Pool Generation, Purified Lambda Heavy chains, Kappa light chain

Involved in the Downstream Process Development for Trastuzumab, Rituximab, Innovators- Anti fucosyl GM1 mAb, BBRC/10-01, BBRC/10-02, BBRC/12-04.

Involved in process development & technology transfer of Ulocuplumab -CXCR4,Urelumab- AntiCD137

Involved in Downstream Process Development for Bispecific Abs (BsAb) from HEK 293, CHO cells

& point of client contact for all the Microbial Innovators

Expression & Purification of Receptors, Growth factor receptors, CD receptors & molecules from E.coli & Insect cell lines (Hi5,Sf9 & Sf21) in shake flasks, mammalian cells (HEK293). Purified Invitro Translation system proteins - 34 proteins (Milla molecular/ Pure Components)

Protein characterization by Thermal Analysis of various proteins by RT-PCR (TSA), Protein Size and characterization study by DLS (Dynamic Light Scattering). Protein interaction by iTC

Established High Throughput screening of protein expression, resin screening, buffer s screening, binding & elution conditions, fusion tag screening, expression level etc

BPR Preparation, TTD Preparation, POC Document for Innovators and supporting downstream document for NBEs

Assisting/Training Junior Scientists in protein expression & purification Vivek Halan Phone: +91-966*******

Bangalore, India. E-mail: acxun3@r.postjobfree.com

Organization: Avesthagen Ltd, Bangalore

Designation: SRF Duration: July 2007- April 2009

Involved in downstream Process Development of PTH from E.coli & Ranibizumab (Fab fragment) from E.coli

PTH purification from IB. Carried out refolding by various methods (Dilution, Dialysis, On Column refolding).IB clarification by Centrifugation & Depth filtration. Buffer exchange and Concentration by TFF (Millipore Lab Scale TFF System)

Purification by Chromatographic & Non chromatographic techniques in lab scale

Learned protein expression in microbial system (E.coli) in laboratory scale. Organization: Magene Life Sciences Pvt. Ltd, Hyderabad Designation: Research Associate, Duration: January 2005 to June 2007

Downstream Process Development of IFN Alpha 2b, gCSF from E.coli from 5 - 10 Lit scale

Protein Expression in salt inducible E.coli strain in Lab scale (8 Lit).Performed various resin screening studies.

Column Packing & Evaluation for DSP. IB solublization, clarification, refolding and filtration by TFF, UF/DF of DS/DP

Organization: National AIDS Research Institute (Pune) Designation: Lab Technician – Duration: March 2004 – Sept 2004

Cytotoxicity Assay, Viral load assay, Cell line maintenance MT-2, SubT1&U 393, MDCK, PBMC cells separation, Co receptor usage assay, LDMS.

Protein expression in COS cells and purification,Anti-HIV protein interaction study, HIV isolation, Viral Load Assay

NON-SCIENTIFIC ROLES

Assisted in organising scientific advisory (SAC) committee meetings.

Compiled and reviewed SOP’s and Work Instructions for various projects.

Involved in meetings & trainings for moving the lab towards ISO certification, NABL accreditation.

Supervised maintenance of most of the equipments used in Lab

Imparted training to new recruits and biotechnology/life sciences graduates PROJECT MANAGEMENT

Managed correspondence with Sponsor Companies of various in-coming projects

Generating report for annual review meeting, prepare Confidentiality Agreement Documents

Preparation of Batch Processing Records (BPR) for Pre-Consistency & Consistency batches

Prepared Process Development Plan for Innovators, Biosimilar & Possess leadership skills to direct a productive team in downstream process development

Periodic Telephonic/Video conference meeting with clients & Compiling Protocols and Reports for Process Optimization

Prepared Dossier for RCGM Approval & Supervising data compilation, analysis, maintenance & archival

Vivek Halan Phone: +91-966*******

Bangalore, India. E-mail: acxun3@r.postjobfree.com

PROFESSIONAL CERTIFICATIONS / TRAININGS / SEMINARS / WORKSHOPS

A dissertation at Central Food Technological Research Institute (CFTRI), Mysore titled

“Insecticidal and Antifungal activity of Penicillium metabolites.

One month Microbiology Training Programme at Shri Mritasanjivini Lab Pvt Ltd on May 2001.

Attended two days training on Project management, six days training E-mail etiquette, Presentation & Business Etiquette. Participated two days team building activities at Pegasus

One-month training programme at National AIDS Research Institute (NARI) -2004. Two day Good Clinical practice-training programme by John Hopkins University, USA, held at NARI, Pune.

Attended a Seminar on Biophysical characterization of Proteins at CCMB, Hyderabad, Conference/training on Unicorn Software, Biacore organized by GE Healthcare Ltd

Five days training on Filtration at Merck Millipore, Bangalore.

As a Speaker : Talk on HTS of Protein Expression & Purification at VIT in Proteomics Conference

(2015)

As a Speaker : Talk on HTS & CEX Chromatography Recovery of mAbs- BioProduction 2016 Conference, Mumbai

As a Speaker: Talk on HTS Platform in 7th Biosimilar Conference-2016 in Shanghai, China PUBLICATIONS (PATENTS & ARTICLES)

A Review article on "Fluorescence-Detection Size-Exclusion Chromatography An Analytical Technique with Multiple Applications " By Vivek Halan, Sunit Maity, Anurag S. Rathore & Ira Krull, December 2014.

Submitted a Review Article on "Mixed mode Chromatography"

Two International patents 1. Process for obtaining Exendin-4 (WO2016005903) 2. Afucosylated proteins (WO2016016842)

AWARDS AND HONOURS

First Rank holder (Gold Medallist) in M.Sc., Biotechnology at Bharathidasan University (2004)

Handled various projects and fruitfully completed within the target time. Proposed a new target for Colon Cancer along with CADD Team.

Received six R & D Star Award for Outstanding performance in various projects (Oncology, Immunology, Inflammation, Neuropathic pain) at Biocon-Bristol Myers Squib Research Centre,(BBRC) Bangalore.

DECLERATION

I hereby declare that the above all the aspects are true and correct to the best of my Knowledge. Yours truly,

(H. VIVEK)

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