Bioprocess Development For Biosimilars And Human Vaccines : Resume CV

[Guest-IJT]

Career Synopsis :
Over 10 years experience in Bioprocess Development, and production optimisation (fermentation, DSP, Purification, Analytical) for Generic Bio therapeutics and Polysaccharide conjugate vaccine Research and Development Operations with problem solving abilities.
People-Management, Teamwork and Project-Management skills to thrive in a fast-paced, results-oriented business environment.
Microbial & Stem cell culture fermentation, downstream process developments & Purification within the constraints of scope, quality, time and cost to deliver specified requirements.
Mapping client's requirements & providing customized, robust and cost effective solutions in liaison with cross-functional activities. Develop and implement production tracking and quality control systems, for analyzing production.
Recently in to Human Mesenchymal Stem Cell Production.

Career Objective & Strengths :
“To competitively make, Safe, Efficacious better quality and cost effective Biopharmaceuticals for global market”
With abilities plan, schedule, track and effective management of metrics such as effort, schedule, product & process quality in Biopharmaceuticals of Healthcare domain.
I offering myself with :
- Bio Process Development for Fermentation/ Purification Scale up and validation for vaccines/Biotherapeutics
- production Problems solving or troubleshooting Client Oriented Approach
- Process Scale up operation & Bioprocess validation. Scoping, Documentation
- Support Maintenance : production Planning Organizing
- Bio-Analytical Techniques development
- Relationship : Team Building, Managing: Dependable Professional

Career Path :
Centre Head- Manipal (GM) (Human Mesenchymal Stem cell Production) ....Jan.’ 10 till now/ At Present Stempeutics Research Pvt. Ltd.
Senior Scientist II (Bioprocess Development) ........ Dec’ 04 – Jan’10 .....6 years Shantha Biotechnics Ltd Hyderabad
Assistant Manager (Polysaccharide Conjugate Vaccine Department)......... Jan’ 00 – Dec’ 04 ....4 years Serum Institute Of India Ltd

CRITICAL ROLES : (BIOPROCESS DEVELOPMENT)
Fermentation Process development :
- Executed & supervised media optimization via growth kinetics Vs product expression studies in shakerflask & CSTR Tank/fermenter in batch, fed batch operation, also studied the cascading & varying of different physical parameters like pH, Temperature, D.O. sperging of different gasses of anaerobic fermentation.
- Handled aerobic Gm -ve cocci, Egan strain, wild strain/ patients isolates (Haemophilus Influenzae Type b), cell banking, during fermentation process optimization.
- studied different fermenter designs during fermentation Scale up study for better yield, robust and economical process (from 1L-10L, 30L-to450L, 100L -1KL)
- Fermentation process development plan and activity for anaerobic pneumococcal Gm +ve cocci, strains cell banking and fermentation study at shaker flask and fermented level in anenarobic condition.
- Supervising fermentation process development activity with hands own experience on Recombinant E.coli [rhGCSF, rhGMCSF, tPA, IL2, rhGH)
- Fermentation study of S. Typhi for Vi-polysaccharide, fermentation study of pneumococcal strains and their cell banking
Mesenchymal Stem cell (MSC) study ( at Stempeutics Research Pvt. Ltd.)
- Scale up study and production optimization of MSCs from T-75 flask to 10CS & 40CS from single and mixed donors.
- Problem solving abilities in MSC production, optimized to Producing 450-500M cells/10CS
- Current capacity of manufacturing 1200 dosage/annum.

Downstream Process Development :
- Optimization for cell harvesting/cell separation & extracellular polysaccharide for Hib, pneumococcal, typhoid
strains. Studied, centrifugation, depth filtration, TFF micro, ultra filtration and their different combination.
- Optimization of extracellular polysaccharide recovery and purification of polysaccharide by fractional
precipitation, combination of cationic detergent, TFF ultrafiltration..
- Optimization of endotoxin removal by studied detergents, fractional precipitation, ultra, micro filtration, column chromatography & finally achieved below 1.5 EU/mg of polysaccharide.
- Optimization of Cell lysis by High pressure homogenigetion/cell lysis for recombinanat E.coli cells,
- Inclusion body (IB) isolation and inclusion body purification optimization
- Carried out optimization of IB solublization (protein denaturation, and reduction of di-sulphide bonds, linearization of protein )
- Study of folding kinetics, optimization of Protein Refolding /renaturation/oxidation, on lab scale and at industrial scale.
- Product concentration via Ultra filtration, column chromatography system selection, optimization and its scale up study
- Removal of refolding agents and adjuncts/exchange with protein stabilizers
- Downstream Process validation.
- Scale up study for better yield, robust and economical process.

Polysaccharide/saccharide –TTd conjugation process optimization :
- Optimization polysaccharide size for proper efficacy of the conjugate tried mild acidic, buffered basic conditions, and by peroxide oxidation monitored & optimized the sizing kinetics for proper fragment size of polysacchdies / sacccharides component
- Studied activation of polysaccharide/saccharide component cynalation by alkaline/ mild & neutral condition with recently developed derivatives for better percentage of activation to for free cHO for ADH coupling.
Studied and controlled ADH coupling of activated saccharide to avoid excessive dimerisation.
- optimised the removal of unutilised/ free ADH from the active and reactive sacchride
- Studied CNBr derivatization of polysaccharide & EDC coupling by john Robbins method.- 18-20% overall yield
- Studied peroxide oxidation& reductive deamination/Schif’s base formation (Jennings method) 62-70% overall yield

Purification process development :
- Downstream & purification process development for Biosimilars rhG-CSF, interferon alpha 2b, EPO, rPA and MAB like RM1 & RM2.
- optimization of HIb-TTd conjugate purification with better step recoveries.
- optimization of purification of TTd for conjugation
- Studied other Saccharide conjugate purification process.
- Administering the development of protein purification process methods for Recombinant Biopharmaceuticals, Chromatography matrix/resin/media screening and selection, purification process optimization on LPLC
- HPLC method development and scale up for preparative HPLC
- Scale-up (process economics), Process validation scale down study for robustness of the process and carried out manufacturing of cGMP clinical and production lots.

Analytical Method Development & Research :
- Supervising development of analytical methods for Biopharmaceuticals (rhGCSF, tPA, rhGMCSF) in-process samples and bulk preparations and validating analytical methods on basis of specificity, linearity, accuracy, precision, range, detection & quantization limit, and robustness as per ICH guidelines.
- Handling planning the analysis of stability samples of research products kept for determination of shelf life as per ICH guidelines.
Documentation / Compliance
- Drafting specification STPs, SOPs, and relevant documents and undertaking analytical method validation and related documents.
- Administering analytical developmental work and documentation of in-house developed analytical methods, Standard Testing Procedures and specifications for routine use by QC personnel
- Carried out Product Characterizations and HPLC-analytical Method Validation.

Equipment and Analytical Knowledge :
Fermenters :
- New Brunswick Scientific :Bioflo-4500, B’ Brawn /Sartorious / Biostat B10, C30, D100, D750 fermenter with automation used mostly for bacterial culture
Cell Lysis Equipment :
- Bead mill : Dynomill, Sonication : branson sonicator
- High pressure homogeniger : French press, Microfludiser
Centrifugation :
- Batch centrifuge : Beckmanes Avanti J20, Continus centrifuge: Westfalia

Analytical /Preparative HPLC :
- Waters HPLC with PDA and RI detector (Millennium, Empower2 software), Agilent HPLC with (Chemstation software), DIONEX IEX HPLC system with (Chromolene software), Kwnour - WellChrome- Praparative HPLC, Low pressure Liquid Chromatography System, Millipore K-prime 40-II Biochromatography system (100-3000 ml/min), Sepragen chromatography system-PALL, Amersham Pharmacia Akta Explorer 100, (method Scouting, ), Akta Bioprocess. Acta prime , GE Amersham, Akta Piolot, GE Amersham Akta Bioprocess 5mm

Rheology :
- Haake Viscometer, Brookfield Rheometer.

Biochemical Skills :
- Enzyme assay and kinetics, immobilization techniques, ELISA, Bioassay, Western blotting, LAL testing
- Different method of Protein Purification & protein assay, Polymerase chain reaction and Electrophoresis (SDS-PAGE), Histological techniques (tissue fixation, Sectioning, Staining).

Biophysical Skills :
- Peptide mapping, HPLC Analysis
- C.D. Spectroscopy for secondary (Unfolded) and Tertiary (Native) structure study to optimize the protein folding, I.R. Spectroscopy, MALDI-TOF, UV-VIS Spectroscopy.
- NMR- Proton 1D 600 MHz , Pattern comparisons study for Polysaccharide conjugate Vaccine

Animal Cell Culture Based Study :
- Handled, propagated, Adapted NFS-60 and TF-1 cell lines for In-vitro bioassay for cyt,okines potency testing
- In-vivo bioassay development for cytokines potency testing

Professional Responsibilities :
1. Mesenchymal Stem cell Production - : (for Stempeutics Research Pvt. Ltd.)
- Scale up study and production optimization of MSCs from T-75 flask to 10CS & 40CS from mixed donors.
- Problem solving abilities in MSC production, optimized to Producing 500M cells/10CS
- Current capacity of manufacturing 1200 dosage/annum.

2.Process Development : for Haemophilus influenza type B conjugate vaccine(for Serum & Shantha total~10 years)
- Facility set-up : (As per the recent WHO & C-GMP requirement)
- Process flow, instrument location, Utility setup, and differential pressure setup in HVAC system, material movement, personnel movement, waste disposal.
- Instrument selection and orderings (URS/DQ), Instruments Set-up, and validation (IQ, OQ, PQ) and trial batch run & process development and optimization.
- Preparation of MFR, BMR, SOPs &validation Documents.
- Preparation of MCB & WCB
- Optimization Media & Physical condition for Fermented :- (improved yield of PRP from 25mg/l to 500mg/l)
- Initial cultivation of Homophiles infuenzae-type b on 20-L batch scale (different media growth characteristic study)
- Studied growth kinetics, biomass improvement by media optimization, and optimization of physical parameters, to improve the PRP yield
- DO Cascading : on line air, oxygen, & agitation cascading for maintenance of set value of D.O. during the growth.
- Fresh media addition (fed-batch) studies
- Scale up study in D100L and finally optimized Hib PRP production in D750L fermenter
- Introduced the prostack open channel cell separation unit.
- Optimized of crude PRP Purification (DSP-1)
- Incorporated endotoxin and Host cell DNA removal step
- Studied characterization of PRP and optimized sizing of PRP to get right immuonogenic candidate for the conjugation
- Optimized the activation of PRP for coupling and conjugation of Modified PRP with TTd.
Implementation of TTd purification by new method.
- Studied different new method of conjugation of immunogenic proteins to Sachharide epitopes.
- Studied and developed and successfully implemented new techniques of conjugate purification.
- helped in fermentation optimization for pneumococcal strains

3.Process Development : for Generic Recombinant Biotherapeutics (Shantha Biotechnics Ltd.)
(1 :GCSF; 2: Interferon alpha -2b.; 3:GM-CSF; 4: r-PA)
- Carried out assessment of Identity, Purity, quality and quantity. Handling of Expression checking, clone selection, fermentation media optimization and fermentation Scale-up
- DO Cascading : on line air, oxygen & agitation cascading for maintenance of set value of D.O. during the growth.
- Handling of optimization Cell disruption, Inclusion body isolation, purification and scale-up.
- Protein Refolding : Studied the kinetics of refolding, CD-spectroscopy, IR-spectroscopy, optimization of refolding & Scale-up
- Selection and optimization for Micro filtration and Ultra filtration system : bench scale study 100 sq CM casette /30L feed, maintaining optimum cross flow to get maximum flux with minimizing protein loss.
- Ultrafiltration TFF scale up to 200L feed with 10.0 sq M area.
- Screening/Selection of chromatographic matrix, optimization for product capture : matrix selection on the basis of physico chemical nature of the target protein and other major contaminants
- Studied binding, column wash and target peak elution at different pH, buffer systems with/without adjuncts targeting best quality product , robust process with optimum yield
- Carried out matrix maximum binding capacity and protein concentration for specific quality of the product with better activity and yield
- Documents preparation and product quality presentation for the Indian regulatory body like IBSC, RCGM and DCGI
- Production facility set up, Instrument, Equipment ordering and its installation at proper location as per process flow in expected timeline and drafting of SOP's for the production.
- CGMP lot preparation for Toxicology and Clinical studies and maintenance and care taker of all DSP and purification Lab Instruments, In charge of DSP and purification.
- Carried out an analytical method development for various forms of Bio-therapeutic. Qualitative & quantities analysis, and establishing their effects on stability in the shelf life.
- Involved in the protocol designing and conducting stability study experiments for the assessment of self life of the product.

Professional Achievements :
- Successfully done trouble shooting and scaled up the Hib-TTd conjugation process (Shantha Biotechnics Ltd Hyderabad and also in Serum Institute Of India Ltd)
- Successfully organized & lead HIB vaccine Development, and pilot production & the issues in pentavelent (D,T, wP, Hep,and Hib).. (Shantha Biotechnics Ltd Hyderabad )
- Successfully resolved the scale up problem’s in Interferon alpfa 2b, EPO and purification problems in Hib, TTd, and whole cell Pertussis. (Shantha Biotechnics Ltd Hyderabad)
- Successfully developed, transferred & implemented production process, analytical methods from R&D to Production and QC respectively (Shantha Biotechnics Ltd Hyderabad)
- Successfully organized production activities to Manufacture Mesenchymal Stem Cells. (Stempeutics Research Ltd.)
- Successfully developed rhG-CSF, t-PA, rhGM-CSF and did troubleshooting for Interferon Alpha 2b, EPO,
rhG-CSF ready for launch while others doing fine in clinical trials and toxicology studies. (Shantha Biotechnics Ltd Hyderabad)
Education
Master Of Technology (Bioprocess Technology)
UDCT, Matunga Mumbai
Bachelor Of Pharmaceutical Sciences
Nagpur University

Trainings Attended :
S.A.P. Training
Training on new product development
cGMP Trainings

[Guest]

I’m writing to express my interest in relevant position at your esteemed organization. My combination of skills and technical expertise makes me the right person to help your organization grow.

I have completed M Sc (Micro Biology) programme and currently holding B Sc (Zoology) degree with first class. I have zeal to learn new things and implement in current role to get it improved and for effective delivery. Even if I am a fresher, I promise to deliver the best from my end for the organizational growth.

If I can provide you with any further information on my background and qualifications, please let me know. I can be reached anytime via email mentioned above.

Thank you for your time and consideration. I look forward to speaking with you about this opportunity.

Sincerely,
Swati V Jadhav

RESUME :
Swati Jadhav
E-mail :swatisalunkhe2011 AT gmail.com

Objective :
Intending to build a career with leading corporate of hi-tech environment with committed and dedicated people, which will help me to explore myself fully and realize my potential. Willing to work as a key player in challenging & creative environment.

Academic :
Exam Passed Board / University Year Percentile :
M.Sc (Micro) KIMS, Karad 2011 60.00%
B.Sc.(Zoology) Shivaji University, Kolhapur 2009 62.88 %
Intermediate (12th) Kolhapur Board 2005 49.83 %
S.S.C. (10th) Kolhapur Board 2003 60.40 %

Projects :
- Project #1 : M.Sc Micro (S.Y) – Isolation of Bacillus Species for the production of alkaline protease from soil of local area.
- Project #2 : B.Sc.Biotech (T.Y) – Biodiversity of Dragon-fly in local region.

Workshops/Seminars/Conferences :
- UGC sponsored state level conference on “Trends in Applied zoology, Environment and Biotechnology” at B.D.C. Patan
- Interdisciplinary Research conference, KIMS, Karad.

Skill sets :
- Medical Microbiology,
- Recombinant DNA Technology,
- Immunology,
- Enzymology

Language Proficiency :
- English
- Hindi
- Marathi

Computer Knowledge :
- Working knowledge of MS - Windows 98/2000/Xp/Vista.
- Basics of C language
- MS-CIT.

Declaration :
I here by declare that the above information is true to the best of my knowledge and belief.

(Swati V Jadhav)