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DR SUMANT CONSULTANCY Dec

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Page 1: DR SUMANT CONSULTANCY Dec
Page 2: DR SUMANT CONSULTANCY Dec

Consultancy Fees :Consultancy Fees :Biopharma-Biologics & Biosimilar, Medical devices etc (taxes extra)

1 day 15,000

7 Day 75,000

15 Days 1,25,000

30 Days 1,80,000

60 Days 2,50,000

90 Day 3,50,000

QA ,QC,Regulatory, -Pharma-Biologics & Biosimilar, Medical devices etc

1 day 7500

7 Day 40,000

15 Days 65,000

30 Days 1,00,000

60 Days 160,000

90 Day 2,50,000

Speaker, Guest Lecture,Reviewe etc

1 Lecture 12500

Guest Lecture 18500

Reviewer etc 10,000

Page 3: DR SUMANT CONSULTANCY Dec

Training Fee : 25,000 to 1,25,000 Training Fee : 25,000 to 1,25,000 INRINRIndividual / Group Training: Individual / Group Training: ONSITE/OffSITEONSITE/OffSITE

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Market Projection/Licensing …350 to Market Projection/Licensing …350 to 2000USD2000USD Blood factor,Plasma Biosimilar Biologics Fermentation and Synthetic API Vaterinary Market Biotech equipment Market Biomedical equipment Market Biocontrol and Biofertilizer Market Down stream/Chromatography Microsphere Biopharma disposable – Reactor,column,consumable Animal cell culture media,cell lines, bacterial cell line Probiotic,prebiotic market

Page 5: DR SUMANT CONSULTANCY Dec

Technical Position Held,Technical Position Held,1. CHIEF SCIENTIFIC OFFICER & COO- BBPL(BILLS BIOTECH PVT

LTD) ,VADODARA GUJARAT

2. HEAD OF R&D & SR. GM AT VIRCHOW BIOTECH PVT LTD,HYDEREBAD

PRODUCT PORTFOLIOS : RH-GCSF,PEG-GCSF,R-URATE OXIDASE,PEG-UOX,R-INSULIN,R-GLARGINE,R-PTH,R-EK,R-CBP,L-ASPARAGINASE,R-TPA,R-EPO,R-PROTEIN A –

3. ASST. GENERAL MANAGER- BIOPHARMA OPERATION AT MICROTHERAPEUTICS RESEARCH LABS PVT LTD

DEVELOPMENT OF – PTH,GLARGINE, PEGFILGRASTIM, ,PEG-IFN, HGH, EPO,IFN-ALPHA 2A, ,NDA, COLLOBRATION OPPORTUNITY WITH OTHER BIOPHARMA COMPANIES FOR PROCEESS,TECHNOLOGY,CLONE,ETC) AND ALSO THE BUSINESS MODEL DECISION FOR PARTNERSHIP, BULK SUPPLIER, QUALITY CHECK, NEGOTIATION, DCGI APPROVALS, FACILITY AUDIT., BIOANALYTICAL METHODS TO QUALIFY THE BULK/API SUPPLIER FOR MABS AND PROTEINS.

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Technical Position Held,Technical Position Held, SR .MANAGER & HEAD - BIOSIMILAR AND BIOLOGICS PROCESS

DEVELOPMENT,RESEARCH & TRAINING ,CONSULTANCY AT BIOZEEN,BANGALORE ◦ GCSF, EPO,IFN, HEPATITIS VACCINE- PROCESS DEVELOP, DOE,PAT, HEADING FERMENTATION, CELL CULTURE, DOWNSTREAM AND

BIOPHARMA VALIDATION LAB, PROCESS CONTROL, TECHNICAL LOOKOUT, R & D LOOKOUT,

◦ AKTA PROCESS, AKTA PILOT, DUAL FERMENTOR, CIP STATION, WAVE BIOREACTOR, AXICHROME, CHROMAFLOW, ATF-CELL CULTURE,CHO,BHK-21

◦ BUSINESS FOR BIOPHARMA PROCESS CONSULTANCY & TRAINING, FORMULATION, GLP, AND VALIDATION.

◦ GLOBAL BUSINESS DEVELOPMENT TO ATTAIN CUSTOMER FROM KOREA, BRAZIL, S.AFRICA, CANADA, IRAN.

Page 7: DR SUMANT CONSULTANCY Dec

Technical Position Held,Technical Position Held,◦ SENIOR RESEARCH SCIENTIST - DOWNSTREAM AT INTAS BIOPHARMACEUTICALS:

◦ GCSF,PEG GCSF,IFN-2B,IL-2,EPO- DOWNSTREAM AND PROTEIN PURIFICATION: EXPERT IN DEVELOPING METHODS ON AKTA PROCESS, AKTA PILOT, AKTAEXPLORER, AKTA PURIFIER & BASIC, BPG COLUMNS OF VARIOUS SCALE (R&D TO PRODUCTION), CHROMA FLOW COLUMN, AXICHROME COLUMN AND PACKING STATION HANDLING AND OPERATION.PROTEIN PURIFICATION STEPS LIKE INCLUSION BODY DISSOLUTION, REFOLDING OF PROTEINS, MEMBRANE BASED MICROFILTRATION (TFF-MF,UF AND DIALYSIS), DOE (DESIGN OF EXPERIMENT CERTIFICATION) FOR DSP AND USP METHOD DEVELOPMENT ON MINITAB BY SSE SOLUTION, BANGALORE), AUTHORIZED TO PROVIDE THE DOE TRAINING AND CERTIFICATE, DESIGN OF EXPERIMENT (MINITAB, DESIGN EXPERT ETC ),

◦ CHROMATOGRAPHY TYPES - SIZE EXCLUSION CHROMATOGRAPHY, AFFINITY CHROMATOGRAPHY, ION EXCHANGE CHROMATOGRAPHY AND HYDROPHOBIC INTERACTION CHROMATOGRAPHY. METHOD DEVELOPMENT AND PROGRAMMING ON AKTA PRIME, BASIC, PURIFIER AND AKTA PILOT

Page 8: DR SUMANT CONSULTANCY Dec

Technical Position Held,Technical Position Held, SENIOR GROUP LEADER FERMENTATION AND SYNTHESIS

R & D AT CONCORD BIOTECH LIMITED ◦ TACROLIMUS,SIROLIMUS,STATINS(LIPSTATIN,PRAVASTATIN,LOVASTATIN),

DAPTOMYCIN,MICAFUNGIN, MOFTEL PHENYLIC ACID- STRAIN IMPROVEMENT,MEDIA OPTIMIZATION,DOE,PAT ETC

◦ 50 L FERMENTATION,100 L FERMENTATION , HPLC METHOD DEVELOPMENT FOR TACROLIMUS ,SIROLIMUS,LOVASTATIN,OTHER STATINS,..SCALE UP TO 10KL ,20KL FERMENTATION SCALES

HEAD - MOLECULAR BIOLOGY AND BIOCHEMISTRY LAB AT INSTITUTE OF HUMAN GENETICS INDIA, ◦ REAL TIME PCR AND NORMAL PCR METHOD DEVELOPMENT FOR

MUSCULAR DYSTROPHY,SICKLE CELL,HAEMOPHILIA,GENETIC DISEASES, AND PATERNITY TEST,MATERNITY TEST ETC

Page 9: DR SUMANT CONSULTANCY Dec

Consultancy servicesConsultancy services Process establishment (CMC+QbD+PAT Approach) : Biologics,Biosimilar,

Biobetters, Vaccines,Biologicals

Fermentation & Cell Culture

Downstream

Primary and secondary Purification Primary Purification : Microfiltration, Ultrafiltration,Diafiltration Secondary Purification : Chromatography : Gel Filtration,Size Exclusion, Ion exchange, Hydrophobic

interaction, Membrane chromatography etc

Product selection- Market analysis,Technical feasibility, cost analysis, risk management

Development – Clone, Host, Vector, Equipment, Staff, selection, Training, Collobration with research labs.

Improvement at existing / runing process for cost cutting and quality compliance.

Compliance - GMP, cGMP, EUGMP, EMEA,USFDA, DCGI,FDA, CDSO, DBT,SIBRI,BIRAC,MENA

DOSSIER for different country, Onsite training

Page 10: DR SUMANT CONSULTANCY Dec

Product handled till Product handled till now…..now…..

Biosimilars & Biologics : Upstream, Downstream,Bioanalytical, Formulation, Stability, Biossay

Development of GCSF,PEG-GCSF,URATE OXIDASE,PEG-UOX,R-INSULIN,R-GLARGINE,R-PTH,R-

EK,R-CBP,L-ASPARAGINASE,R-TPA,R-EPO,R-PROTEIN A

DEVELOPMENT OF – PTH, GLARGINE, PEGFILGRASTIM, ,PEG-IFN, HGH, EPO,IFN-ALPHA 2A .

MABS : RITUXIMAB

Biologicals: 100 KL Scale Fermentation + Downstream

Tacrolimus,Sirolimus,MPA,mupirocin

Micafungin,Atorvastatin,Pneumocandin

Lovastatin, Pravastatin

Statins – Orlistat,Lipstatin,Pentostatin

Probiotics

Biosurfactant

Page 11: DR SUMANT CONSULTANCY Dec

Clientele list …..Clientele list …..INTERNATIONAL CLIENTS

Company Product Consultancy Project Cost

1 Client 1,Tehran Erythropoetin – alpha and Beta

Ongoing trials

2 Client 2Egypt,Cairo GCSF,Insulin Ongoing

INDIAN CLIENTS

4 BBPL,Vadodara Tacrolimus & Orlistat

Project Completed

5 KM Biotech Pvt Ltd, Chennai

r-PTH,r-Glargine Completed

6 XXXBioscience,Hyderabad Biologics Process Undisclosed

7 PBR Private Ltd,XXX Preclinical for Biosimilars

Undisclosed

Page 12: DR SUMANT CONSULTANCY Dec

Market Analysis/projection Market Analysis/projection clients-2013-15 clients-2013-15 IMS – Mumbai Office Smart cube Markets and Markets Beroe Insight Alpha Infolin Precision Advisors,55 Cambridge

Parkway, Suite 300E  ETC

Page 13: DR SUMANT CONSULTANCY Dec

Thanks & Regards,Thanks & Regards,

Dr Sumant Chaubey,PhD, PGDRA,

Global Process Consultant for Biologics, Biosimilars, Biobetters and Biologicals API Manufacturing

Clone Design,Develop,Scale Up & Large Scale Manufacturing of BiologicsRecombinant E.coli and Cell Culture- Upstream,Downstream, Bioanalytical,(CMC,PAT,DOE,TT,FDA,cGMP,EMEA,ICH,21CFR Expert),Regulatory, Affair Expert(IP,BP, EP,USP,DCGI,FDA,USFDA),DMF filling expert,Different Country Dossier) - 15 Years of Experience.

Invited Speaker  at 1. World Biologics -2015 http://www.imapac.com/speaker/dr-sumant-chaubey/2. 1st Asian DOE workshop and conference http://www.systechglobal.co.in/doe-old.aspx3. Bioprocess India -2014 ,http://www.bioprocessingindia.org/speakers.htmlBlog : https://blog.zintro.com/2015/02/10/competition-affecting-big-pharma/

Page 14: DR SUMANT CONSULTANCY Dec

Thank you so much for connecting to DSC Bioprocess consultancy service.

You can reach any time to me at, [email protected]

[email protected]

skype: sumant.chaubey whatsapp : 00(+91)-9036992907

contact number ; 00(+91)-9898639929