Sunil Mahor (M. Pharm. Ph.D.)

acvks3@r.postjobfree.com +91-976-493-0055I linkedin.com/in/sunilmahor

Formulation and Process Development Manager

Senior Formulation & Process Development Technologist • Early stage Product Development R&D Professional for >9 Years (Post Ph.D.) in Leadership Role for Injectables and Solid Dosage Form in Lead Biopharmaceutical Industries • Subject Area Expertise in Novel and Advanced Protein/Peptides Delivery Technologies for macromolecules NBEs such as oligonucleotides, DNA, whole virus particles • New Generation of Gene and siRNA Delivery and Drug Targeting based Drug Product Design •Particle design and Engineering

Subject matter expert – Combined and complex biopharma product development (Proteins, Mab’, Vaccine and Gene), particles based vaccine formulations, New generation of adjuvant system(s), Understanding of stability challenges and develop strategies for stabilization, Thermostabilization by Lyophilization and spray drying, New and existing pre-formulation and formulation platforms, Bio-conjugation in large scale protein formulations, Solid state Characterization.

Technical expertise in multiple biophysical techniques to support pre-formulation and Early Stage Development Studies for Proteins, Nucleotides and Viral vectors.

Lead development studies of complex formulations to support various phases of clinical development including Formulation R&D, Scale up, Technology Transfer and cGMP Manufacturing process.

Leadership in process development projects in a cross function matrix team environment and able to write SOPs, Regulatory dossier, Scientific Reports and Protocols biopharma product(s) for regulated and unregulated Markets.

Due Diligence in Evaluation of Developability of Antigen Candidate, Novel Delivery and Fill-Finish Technologies

Working ability with Experimental Design and Data Interpretation in Formulation and Process Optimization by Quality by Design (QbD), Design of Experiments (DoE) and statistical, Data Evaluation Techniques.

Intellectual achievements – 20+ Articles (International Peer-reviewed Journals), 12+ Abstract (Conferences), 3 IP + 2 Book chapter (International edited book)

Employee Training, Development & Leadership

Knowledge of EMEA, ICH and FDA Guidelines

Professional experience

Serum Institute of India Pvt. Ltd., Pune 2013–Present

Manager-Formulation Development Pune India 2013–Present

Scientist – Formulation (R&D) MSD’s JV Hilleman Laboratories Pvt. Ltd. Delhi 2011-2013

Research Scientist (R&D) – NFB, Galway, Ireland 2009–2011

Assistant Manager (R&D) VB Medicare Pvt Ltd, India 2008-2009

Post-Doctoral Research Scientist (R&D), VIDO-InterVac, Saskatoon CANADA 2006-2008

Senior Research Fellow – CSIR Delhi India (Dr. HS Gour Central University INDIA) 2002-2006

Junior Research Fellow – UGC Delhi (Dr. HS Gour Central University INDIA) 1999-2001

Notable achievements:

Worked in a multiple increasingly responsibility from Laboratory (bench) scientist to Middle management positions based on strong Technical knowledge, in-depth understanding of formulation science of highly labile and sensitive biomolecules, team building and leadership performance. Currently leading a team of 20 scientists and reporting directly to the Head of the Department.

Won “Team-Above and beyond Award” in my Leadership for scientific outcome of the research project in successfully achieving VVM30 for dry powder based Rotavirus vaccine in our early trials.

Successfully identified the process related troubles in combination vaccine formulations responsible for instability of conjugate vaccine antigen and limited adsorption and suggested multiple strategies to overcome the instability challenges in multivalent combination vaccine.

Troubleshoot in Hib bulk conjugates manufacturing process by providing better storage and handling system using the stabilization approach for Ease in Hib bulk manufacturing.

Successfully accomplished the Pneumococcal 10-valent Conjugate Vaccine Formulation drug product that is currently in Clinical Phase II Trial Stage. The Formulation technology is protected under IP.

Studies are in Early Preclinical Development of New generation Universal Pneumococcal protein based vaccine with US collaboration

Scholastic achievements and Awards

Team – Above and Beyond Award 2013 by MSD-Wellcome Trust Hilleman Labs Pvt. Ltd in 2013.

Science Foundation Ireland-Research Fellow awarded by Science Foundation Ireland in 2009.

GATE-1999 Qualified with score 88.83 Percentile conducted by I.I.T. Mumbai

Merit Position in M. Pharm. Merit list of Dr. H.S. Gour University Sagar (2001).

UGC-Junior Research Fellowship for M. Pharm. studies (1999-2001)

Senior Research Fellowship awarded by CDRI Lucknow (2003)

Research Paper nominated for Pfizer’s Capsugel Award by Controlled Release Society USA 2004

Senior Science Fellowship awarded by Lady Tata Memorial Trust Mumbai (2003)

Senior Research Fellowship (SRF) awarded by CSIR New Delhi for Ph.D. studies (2003)

“Outstanding contribution in Reviewing-2015” award for International Journal of Pharmaceutics by Elsevier Publication UK

Won Medals and Prizes in Singing, Cricket, Table Tennis, Quiz and Chess

Education

2006 – Doctor of Philosophy (Ph. D.) in Pharmaceutical Science, Dr. H.S. Gour Central University India

2001– Masters in Pharmacy (M. Pharm.) Pharmaceutics, Dr. H.S. Gour Central University India

1999 – Bachelor in Pharmacy (B. Pharm.) Dr. H.S. Gour Central University India

Professional training and Workshops

Radiation Safety Course conducted by Department of Health Safety & Environment (DHSC) University of Saskatchewan, Canada (2007)

Biosafety Course conducted by DHSC, University of Saskatchewan, Canada (2007)

Laboratory Safety Course by DHSC, University of Saskatchewan, Canada (2007)

INDO-US Joint Workshop on Adjuvants, Delivery Systems and Combination Vaccines, (2004)

Workshop on Quality by Design II (QbD) organized by GE Healthcare India

Training Workshop on Spray Drying Process & Scale-up at Buchi Instrument Flawil Switzerland (2012)

Workshop on Lyophilisation, Process scale up and Troubleshooting (2012) by SP Scientific USA

Technical skills

Development of dosage forms- Oral Solids, Powders dissolution using USP 1&2 apparatus, emulsion and suspension (zeta potential and particle size analysis, degree of flocculation and sedimentation evaluation)

Drug Delivery Research & Development – Controlled and extended release oral solid dosage form, Formulation development of Microspheres, Liposomes, Nanoparticles Technologies for Drug and Protein Delivery, Micelles, Solubilization Technology for Parenteral Drug Delivery, Synthetic Carriers Design for enhance gene delivery, Non-invasive (Oral, Nasal and Topical) Drug Delivery for Proteins and Peptides Drugs

Thermo-stabilization Techniques – Spray drying, Lyophilization, Lyophilized product and cycle development, Formulation optimization by Quality by Design (QbD) approach

Scale up and Technology Transfer - Free flowing PLGA and composite microspheres by spray drying technique

In Vitro - Excellent hand on Primary and Secondary cell culture techniques, ELISA and ELISPOT assays for immune response evaluation.

In vivo / Pharmacokinetics - Administration by IV, IM, SC and endotracheal route; collection of blood, mucosal fluid, bronchoalveolar lavage fluid; In vivo tumor models; extraction of drug(s) from blood and tissues for bio-distribution analysis, PK analysis (Kinetica and WinNonlin Software)

Writing Skills - SOP, articles and provisional patent

Quality by Design (QbD) - Working knowledge of Design of Experiments (DoEs), Design space, Process analytical Tools (PATs) in Formulation Development and optimization Process, Lyophilization cycle development, formulation optimization by “Quality by Design” approach

Instrumentation and Analytical Skills

Experience in operating Lyophilizer, Spray dryer, extruder and spheroniser, spectrofluorometry Gel Documentation system, Particle size analyzer, Multiple Plate reader, HPLC, FTIR, Gel permeation Chromatography (GPC), SDS-PAGE, Western blotting, Transfections, Fluorescent microscopy, Atomic Force Microscopy, Scanning and Transmission Electron Microscopy, Flow Cytometry, UV Spectrophotometer, Spectrofluorometer, HPLC, DSC (Perkin Elmer), TGA(Perkin Elmer), PXRD, Research Viscometers.

Computer and Software

Proficient knowledge of scientific software packages for data processing and presentation. Proficiency in Internet surfing and Microsoft office (Word, Excel, Power point), Graph Pad Prism, Corel draw, ChemDraw, Adobe Photoshop and JMP design of experiment program

In Vivo Animal Handling

Experience in conducting animal experiments as per the Animal Care & Ethical Committee Guidelines

Knowledge of Patent analysis, cGMP's, FDA regulations, and Drug Development process

Experience in working in GLP standard research facility

Scientific Achievements (Patents/Publications/Book Chapters/ Conference Proceedings)

Please Refer ANNEXURE – 1

ANNEXURE -1

Patents/Invention Disclosure Filed

S. Mahor, A. Pandit (2011) Functionalized nanohybrids for targeted gene delivery to macrophage (Invention disclosure #G-47/2012 filed through Office of Commercialization of Technology, National University of Ireland Galway)

S. Mahor, A. Pandit (2010) Hyaluronan nanoparticles for controlled release application (Invention disclosure # G-91/2010 filed through Office of Commercialization of Technology, National University of Ireland Galway)

R.M. Dhere, H.K. Malviya, S.K. Jana, S.S. Pisal, A.D. Mallya, M.M.K. Gautam, S. Mahor, C.V. Joshi, M.V. Vamsi Krishna, P.S. Jadhav (2015) Methods for improving the adsorption of polysaccharide protein conjugates and multivalent vaccine formulation obtained thereof (2185/MUM/2015).

International Book (Ed.) Chapter

Dubey P.K., Mahor S., Vyas S.P. 2006. RGD modified liposomes for tumor targeting In: Nanotechnology in Cancer therapy. Edited by Mansoor M. Amiji, Published by Taylor and Francis LLC, 643-662.

Mahor S., Collin E., Dash B., Eglin D., Pandit A. 2010. Recent Advances in Biomaterial Based Tissue Engineering for Intervertebral Disc Regeneration. In: Cells and biomaterials for Intervertebral disc regeneration (Synthesis lecture on Tissue Engineering) Published by Morgan & Claypool Publishers USA, 43-94.

Key Research Publications (Peer Reviewed International Journals)

1.Mahor S, Joshi C, Malviya H, Dhere RM. Stability of Haemophilus influenzae b polyribosylribitol phosphate (PRP)–tetanus toxoid (TT) conjugates in Aqueous Solution. (Manuscript under Draft 2016).

2.Collin E, Mahor S, Kilcoyne M, Hendig D, Grad S, Alini M, Pandit A. Upstream Upregulation of Glycosaminoglycans Production by Targeting Synthesizing Enzymes Using A Nonviral Gene Delivery Method for Intervertebral Disk Regeneration. Global Spine Journal, 09/2012: 02(S 01).

3.Mahor, S., Dash, B., O’Connor, S., Pandit, A. Mannosylated Polyethyleneimine-hyaluronan Nanohybrids for Targeted Gene Delivery to Macrophage-like Cell Lines. Bioconjugate Chemistry, 2012: 23 (6): 1138–1148.

4.Mahor S, Collin E, Dash BC, Pandit A. Controlled Release of Plasmid DNA from Hyaluronan Nanoparticles’. Current Drug Delivery, 2011: 8: 354-62.

5.Dash BC, Mahor S, Carroll O, Mathew A, Wang W, Woodhouse KA, Pandit A. Tunable elastin-like polypeptide hollow sphere as a high payload and controlled delivery gene depot. J Control. Release, 2011: 152: 382-92.

6.Mahor S, Rawat A, Dubey PK, Gupta PN, Khatri K, Goyal AK, Vyas SP. Cationic transfersomes based topical genetic vaccine against hepatitis B. Int. J. Pharm., 2007: 340: 13-19.

7.Mahor S, Gupta PN, Rawat A, Vyas SP. A needle-free approach for topical immunization: antigen delivery via vesicular carrier system(s) Current Medicinal Chemistry, 2007: 14: 2898-2910.

8.Rawat A., Vaidya B., Khatri K., Goyal A.K., Gupta P.N., Mahor S., Paliwal R., Rai S., Vyas S.P. Targeted intracellular delivery of therapeutics: an overview. Pharmazie, 2007: 62: 643-658.

9.Rai S, Paliwal R, Vaidya B, Gupta PN, Mahor S, Khatri K, Goyal AK, Rawat A, Vyas SP. Estrogen(s) and analogs as a non-immunogenic endogenous ligand in targeted drug/DNA delivery. Current Medicinal Chemistry, 2007: 14: 2095-2109.

10.Paliwal R, Rai S, Vaidya B, Mahor S, Gupta PN, Rawat A, Vyas SP. Cell-selective mitochondrial targeting: progress in mitochondrial medicine. Current Drug Delivery, 2007: 4: 211-224.

11.Mishra N, Gupta PN, Mahor S, Khatri K, Goyal AK, Vyas SP. ‘Liposomes as adjuvant for combination vaccines’. Indian J. Exp. Biol., 2007: 45: 237-241.

12.Vyas SP, Rawat M, Rawat A, Mahor S, Gupta PN. PEGylated protein encapsulated multivesicular liposomes: a novel approach for sustained release of interferon alpha. Drug Dev. Ind. Pharm., 2006: 32: 699-707.

13.Mishra V, Mahor S, Rawat A, Gupta PN, Dubey P, Khatri K, Vyas SP. Targeted brain delivery of AZT via transferrin anchored pegylated albumin nanoparticles. J. Drug Target., 2006: 14: 45-53.

14.Mishra V, Mahor S, Rawat A, Dubey P, Gupta PN, Singh P, Vyas SP. Development of novel fusogenic vesosomes for transcutaneous immunization. Vaccine, 2006: 24: 5559-5570.

15.Gupta PN, Mahor S, Rawat A, Khatri K, Goyal A, Vyas SP. Lectin anchored stabilized biodegradable nanoparticles for oral immunization 1. Development and in vitro evaluation. Int. J. Pharm., 2006: 318: 163-173.

16.Goyal AK, Rawat A, Mahor S, Gupta PN, Khatri K, Vyas SP. Nanodecoy system: a novel approach to design hepatitis B vaccine for immunopotentiation. Int. J. Pharm., 2006: 309: 227-233.

17.Katare R Gupta PN, Mahor S, Rawat A, Khatri K, Katare Y, Panda AK, Vyas SP. Development of polysaccharide capped niosomes for oral immunization of tetanus toxoids. Journal of Drug Delivery Science and Technology, 2006: 16(3): 167-172.

18.Vyas SP, Singh RP, Jain S, Mishra V, Mahor S, Singh P, Gupta PN, Rawat A, Dubey P. Non-ionic surfactant based vesicles (niosomes) for non-invasive topical genetic immunization against hepatitis B. Int. J. Pharm., 2005: 296: 80-86.

19.Khatri K, Rawat A, Mahor S, Gupta PN, Vyas SP. Hepatitis B surface protein docked vesicular carrier for site specific delivery to liver. J. Drug Target., 2005: 13: 359-366.

20.Gupta PN, Mishra V, Singh P, Rawat A, Dubey P, Mahor S, Vyas SP. Tetanus toxoid-loaded transfersomes for topical immunization. J. Pharm. Pharmacol., 2005: 57: 295-301.

21.Gupta PN, Mishra V, Rawat A, Dubey P, Mahor S, Jain S, Chatterji DP, Vyas SP. Non-invasive vaccine delivery in transfersomes, niosomes and liposomes: a comparative study. Int. J. Pharm., 2005: 293: 73-82.

22.Dubey PK, Mishra V, Jain S, Mahor S, Vyas SP. Liposomes modified with cyclic RGD peptide for tumor targeting. J. Drug Target., 2004: 12: 257-264.

Papers/Poster/Abstracts Presented/Published in Conferences

1.Collin E, Mahor S. Kilcoyne M, Hendig D, Grad S, Alini M, Pandit A, Upstream Up-regulation of Glycosaminoglycans Production by Targeting Synthesizing Enzymes Using a Non-Viral Gene Delivery Method for Intervertebral Disc Regeneration. World Forum for Spine Research, 18-21 June 2012 in Helsinki, Finland.(Podium)

2.Hüther H, Mahor S, Carr E, Watson L, Pandit A. Deciphering the mechanism of hyaluronic acid treatment for interstitial cystitis in an in vitro bladder model. Presented at the 24th European Conference on Biomaterials, September 4th-9th 2011, Dublin, Ireland. (Podium)

3.Dash BC, Holladay C, Carroll O, Mahor S, Woodhouse K, Pandit A. A bifunctional and temporo-spatial delivery through an injectable elastin-like polypetide scaffold. Presented at 24th European Conference on Biomaterials, September 4th-9th 2011, Dublin, Ireland. (Podium)

4.Collin, E, Mahor S, Kilcoyne M, Guicheux J, Hendig D, Grad S, Alini M, Pandit A, Up-regulation of Glycosaminoglycans in Invertebral Disc using a Functionalised Hyaluronan Nanoparticles. 24th European Conference on Biomaterials, September 4th-9th 2011, Dublin, Ireland. (Podium)

5.Mahor, S., Newland, B., Collin, E., Dash, B.C., Carr, E., Wang, W., Pandit, A. Hyaluronic Acid based Nano Assemblies for Enhanced Gene Delivery to Nucleus Pulposus and Annulus Fibrosus Cells. Presented at 24th European Conference on Biomaterials, September 4th-9th 2011, Dublin, Ireland. (Podium)

6.Mahor S, Collin E, Dash BC, Pandit A. Hyaluronan nanospheres for sustained gene delivery” Presented at TERMIS-EU Chapter 2010 Galway 14th- 17th June, 2010 Ireland. (Podium)

7.Mahor S, O’Connor S, Collin E, Dash BC, Pandit A. Mannosylated nanocarriers based on hyaluronan for targeted gene delivery to macrophages Presented at 23rd Annual meeting of European Society of Biomaterials, 2010, Tempere Finland September 12-14, 2010. (Podium)

8.Mahor S, Singh RP, Vyas SP. Non-ionic surfactant based vesicles (niosomes) for non-invasive topical genetic immunization against hepatitis B. Presented at 2nd International Conference on Recent Advances in Biomedical and Therapeutic Sciences held in Jhansi [UP] from 6-8 January 2005. (Podium)

9.Mahor S, Rawat A, Dubey P, Vyas SP. Evaluation of adjuvant properties of poly(amidoamine) dendrimer based conjugates of bovine serum albumin, Presented at AAPS Annual Meeting and Exposition, November 6-10, 2005 in Nashville, Tennessee, USA. (Poster)

10.Mahor S, Rawat A, Dubey P, Mishra V, Vyas SP. Investigation of adjuvant effect of novel PAMAM dendrimer based bioconjugates of BSA immunogen. Presented at 6th International symposium on Advances in Technology and Business Potential of New Drug Delivery System, Controlled Release Society- Indian Chapter held in Mumbai (INDIA) on 17-18 Feb 2005. (Poster)

11.Mahor S, Rawat A, Dubey P, Vyas SP. Polyionic complexes of PAMAM dendrimer and Bovine Serum Albumin: an investigation of immune response. Presented at Controlled Release Society 31st Annual Meeting in Hawai USA in 2004. (Poster)

12.Dubey P, Mishra V, Mahor S, Rawat A, Vyas SP. YIGSR modified liposomes for targeted delivery of 5-FU in tumor metastasis. Presented at Controlled Release society 31st Annual Meeting in Hawai USA in 2004. (Poster)

13.Gupta PN, Mahor S, Rawat A, Dubey P., Vyas SP. Hepatitis B surface antigen loaded chitosan microparticles for oral immunization: Development and in-vitro characterization Presented at 7th Asia-pacific chitin & Chitosan Symposium 23-26 April 2006, organized by Korean society of Chitin and Chitosan. Busan, S. Korea. (Poster)

14.Mahor S, O’Connor S, Collin E, Dash BC, Pandit A. Mannosylated Hyaluronan: An Extra-cellular Matrix based Nanocarriers for Targeted Gene Delivery to Macrophages. Presented at 37th Annual meeting of Controlled Release Society Oregaon USA in 2010 (Poster).

15.Mahor, S., Vyas S.P. PAMAM dendrimers as an Adjuvant against Hepatitis B. presented at “DNA: 50 Years” a National Seminar held in Sagar [MP] sponsored by MPCOST Bhopal and DBT New Delhi in June 2004 (Poster).

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