SlideShare a Scribd company logo
1 of 14
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
Training Fee : 25,000 to 1,25,000 INRTraining Fee : 25,000 to 1,25,000 INR
Individual / Group Training: ONSITE/OffSITEIndividual / Group Training: ONSITE/OffSITE
Market Projection/Licensing …350 to 2000USDMarket Projection/Licensing …350 to 2000USD
 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
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.
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.
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
Technical Position Held,Technical Position Held,
 SENIOR GROUP LEADER FERMENTATION AND SYNTHESIS R
& D AT CONCORD BIOTECH LIMITED
◦ TACROLIMUS,SIROLIMUS,STATINS(LIPSTATIN,PRAVASTATIN,LOVASTATIN),DAPT
OMYCIN,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
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
Product handled till now…..Product handled till 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
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
Market Analysis/projection clients-Market Analysis/projection clients-
2013-152013-15
 IMS – Mumbai Office
 Smart cube
 Markets and Markets
 Beroe
 Insight Alpha
 Infolin
 Precision Advisors,55 Cambridge
Parkway, Suite 300E 
 ETC
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
Biologics
Recombinant 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.aspx
3. Bioprocess India -2014 ,http://www.bioprocessingindia.org/speakers.html
Blog : https://blog.zintro.com/2015/02/10/competition-affecting-big-pharma/
 Thank you so much for connecting to DSC
Bioprocess consultancy service.
 You can reach any time to me at,
 sumant.biopharmaexpert@gmail.com
Sumant.msu@gmail.com
 skype: sumant.chaubey
 whatsapp : 00(+91)-9036992907
 contact number ; 00(+91)-9898639929

More Related Content

What's hot (12)

Diagnostic Kits
Diagnostic KitsDiagnostic Kits
Diagnostic Kits
 
Profile 2 converted
Profile 2 convertedProfile 2 converted
Profile 2 converted
 
Eric Ittah - Consultant Neopharm Labs | Eric Ittah
Eric Ittah - Consultant Neopharm Labs | Eric IttahEric Ittah - Consultant Neopharm Labs | Eric Ittah
Eric Ittah - Consultant Neopharm Labs | Eric Ittah
 
Legislation Regulation of Food Products as per FDA
Legislation Regulation of Food Products as per FDALegislation Regulation of Food Products as per FDA
Legislation Regulation of Food Products as per FDA
 
Vergo - Corporate presentation-3 June 2016
Vergo - Corporate presentation-3 June 2016Vergo - Corporate presentation-3 June 2016
Vergo - Corporate presentation-3 June 2016
 
Legislation Regulation of Food Products as per BSI and Agmark.
Legislation Regulation of Food Products as per BSI and Agmark.Legislation Regulation of Food Products as per BSI and Agmark.
Legislation Regulation of Food Products as per BSI and Agmark.
 
Canvax Catalog 2017 - Accelerating your Molecular Biology Discoveries
Canvax Catalog 2017 - Accelerating your Molecular Biology DiscoveriesCanvax Catalog 2017 - Accelerating your Molecular Biology Discoveries
Canvax Catalog 2017 - Accelerating your Molecular Biology Discoveries
 
API Supply
API SupplyAPI Supply
API Supply
 
Ranvver sharma ppt
Ranvver sharma pptRanvver sharma ppt
Ranvver sharma ppt
 
Aizant Corporate Ppt
Aizant Corporate  PptAizant Corporate  Ppt
Aizant Corporate Ppt
 
Pharma And Biotech Brochure 2009
Pharma And Biotech Brochure 2009Pharma And Biotech Brochure 2009
Pharma And Biotech Brochure 2009
 
DV Biologics Overview
DV Biologics OverviewDV Biologics Overview
DV Biologics Overview
 

Viewers also liked

Ema fda joint inspections
Ema fda joint inspectionsEma fda joint inspections
Ema fda joint inspectionsVaska Toné
 
Top 20 observation series # 6 21 CFR 211.165 - Testing and release for dist...
Top 20 observation series # 6   21 CFR 211.165 - Testing and release for dist...Top 20 observation series # 6   21 CFR 211.165 - Testing and release for dist...
Top 20 observation series # 6 21 CFR 211.165 - Testing and release for dist...Sathish Vemula
 
Intas Biopharma Brochure
Intas Biopharma BrochureIntas Biopharma Brochure
Intas Biopharma BrochureNobby Paul
 
FDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical Trials
FDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical TrialsFDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical Trials
FDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical TrialsSGS
 
Top 20 observation series 1 21 CFR 211.160
Top 20 observation series 1   21 CFR 211.160Top 20 observation series 1   21 CFR 211.160
Top 20 observation series 1 21 CFR 211.160Sathish Vemula
 
Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016
Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016
Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016Sathish Vemula
 

Viewers also liked (10)

GAJJAR DHARMESH1
GAJJAR DHARMESH1GAJJAR DHARMESH1
GAJJAR DHARMESH1
 
Thesis Final
Thesis FinalThesis Final
Thesis Final
 
Ema fda joint inspections
Ema fda joint inspectionsEma fda joint inspections
Ema fda joint inspections
 
Top 20 observation series # 6 21 CFR 211.165 - Testing and release for dist...
Top 20 observation series # 6   21 CFR 211.165 - Testing and release for dist...Top 20 observation series # 6   21 CFR 211.165 - Testing and release for dist...
Top 20 observation series # 6 21 CFR 211.165 - Testing and release for dist...
 
Intas Biopharma Brochure
Intas Biopharma BrochureIntas Biopharma Brochure
Intas Biopharma Brochure
 
FDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical Trials
FDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical TrialsFDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical Trials
FDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical Trials
 
Top 20 observation series 1 21 CFR 211.160
Top 20 observation series 1   21 CFR 211.160Top 20 observation series 1   21 CFR 211.160
Top 20 observation series 1 21 CFR 211.160
 
Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016
Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016
Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016
 
vikram Resume 2016
vikram Resume 2016vikram Resume 2016
vikram Resume 2016
 
DR SUMANT CONSULTANCY F
DR SUMANT CONSULTANCY FDR SUMANT CONSULTANCY F
DR SUMANT CONSULTANCY F
 

Similar to DR SUMANT CONSULTANCY Dec

Platforms for mAb Commercialization
Platforms for mAb Commercialization Platforms for mAb Commercialization
Platforms for mAb Commercialization KBI Biopharma
 
HIV Vaccines Process Development & Manufacturing - Pitfalls & Possibilities
HIV Vaccines Process Development & Manufacturing - Pitfalls & PossibilitiesHIV Vaccines Process Development & Manufacturing - Pitfalls & Possibilities
HIV Vaccines Process Development & Manufacturing - Pitfalls & PossibilitiesKBI Biopharma
 
HJB CDMO Introduction (2019)
HJB CDMO Introduction (2019)HJB CDMO Introduction (2019)
HJB CDMO Introduction (2019)XiaomingJerryYang
 
Highly accelerated platforms for mAb and next generation mAb manufacturing
Highly accelerated platforms for mAb and next generation mAb manufacturingHighly accelerated platforms for mAb and next generation mAb manufacturing
Highly accelerated platforms for mAb and next generation mAb manufacturingKBI Biopharma
 
Paul Clayton - Traceability Impacts on Future Meat Trade Opportunities
Paul Clayton - Traceability Impacts on Future Meat Trade OpportunitiesPaul Clayton - Traceability Impacts on Future Meat Trade Opportunities
Paul Clayton - Traceability Impacts on Future Meat Trade OpportunitiesJohn Blue
 
American Peptide Co. Overview
American Peptide Co. OverviewAmerican Peptide Co. Overview
American Peptide Co. Overviewkarlfischer
 
Pharma API Manufacturers in India
Pharma API Manufacturers in IndiaPharma API Manufacturers in India
Pharma API Manufacturers in IndiaAarti Pharmalabs
 
RONALD PREIBIS Resume Fall 2016
RONALD PREIBIS Resume Fall 2016RONALD PREIBIS Resume Fall 2016
RONALD PREIBIS Resume Fall 2016Ronald Preibis
 
GCP and Conduct in Clinical Research - FINAL
GCP and Conduct in Clinical Research - FINALGCP and Conduct in Clinical Research - FINAL
GCP and Conduct in Clinical Research - FINALSamuel May
 
Getting Biopharmaceutical Production Processes Right the First Time
Getting Biopharmaceutical Production Processes Right the First TimeGetting Biopharmaceutical Production Processes Right the First Time
Getting Biopharmaceutical Production Processes Right the First TimeKBI Biopharma
 
Study 5: Pre-commissioning Safety Review
Study 5: Pre-commissioning Safety ReviewStudy 5: Pre-commissioning Safety Review
Study 5: Pre-commissioning Safety ReviewGerard B. Hawkins
 
2015 Fawzy Hassan CV+ pro+train
2015 Fawzy Hassan CV+ pro+train2015 Fawzy Hassan CV+ pro+train
2015 Fawzy Hassan CV+ pro+trainFawzy Hassan
 
The Bioprocessing Summit 2014 Agenda
The Bioprocessing Summit 2014 AgendaThe Bioprocessing Summit 2014 Agenda
The Bioprocessing Summit 2014 Agendanproulx
 

Similar to DR SUMANT CONSULTANCY Dec (20)

Biopharma Process consultancy
Biopharma Process consultancyBiopharma Process consultancy
Biopharma Process consultancy
 
Platforms for mAb Commercialization
Platforms for mAb Commercialization Platforms for mAb Commercialization
Platforms for mAb Commercialization
 
Ranjeet resume (1)
Ranjeet resume (1)Ranjeet resume (1)
Ranjeet resume (1)
 
Ranjeet Resume (1)
Ranjeet Resume (1)Ranjeet Resume (1)
Ranjeet Resume (1)
 
Praveen galla (2)
Praveen galla (2)Praveen galla (2)
Praveen galla (2)
 
HIV Vaccines Process Development & Manufacturing - Pitfalls & Possibilities
HIV Vaccines Process Development & Manufacturing - Pitfalls & PossibilitiesHIV Vaccines Process Development & Manufacturing - Pitfalls & Possibilities
HIV Vaccines Process Development & Manufacturing - Pitfalls & Possibilities
 
HJB CDMO Introduction (2019)
HJB CDMO Introduction (2019)HJB CDMO Introduction (2019)
HJB CDMO Introduction (2019)
 
Mycenax Introduction_
Mycenax Introduction_Mycenax Introduction_
Mycenax Introduction_
 
Highly accelerated platforms for mAb and next generation mAb manufacturing
Highly accelerated platforms for mAb and next generation mAb manufacturingHighly accelerated platforms for mAb and next generation mAb manufacturing
Highly accelerated platforms for mAb and next generation mAb manufacturing
 
Paul Clayton - Traceability Impacts on Future Meat Trade Opportunities
Paul Clayton - Traceability Impacts on Future Meat Trade OpportunitiesPaul Clayton - Traceability Impacts on Future Meat Trade Opportunities
Paul Clayton - Traceability Impacts on Future Meat Trade Opportunities
 
American Peptide Co. Overview
American Peptide Co. OverviewAmerican Peptide Co. Overview
American Peptide Co. Overview
 
Pharma API Manufacturers in India
Pharma API Manufacturers in IndiaPharma API Manufacturers in India
Pharma API Manufacturers in India
 
RONALD PREIBIS Resume Fall 2016
RONALD PREIBIS Resume Fall 2016RONALD PREIBIS Resume Fall 2016
RONALD PREIBIS Resume Fall 2016
 
GCP and Conduct in Clinical Research - FINAL
GCP and Conduct in Clinical Research - FINALGCP and Conduct in Clinical Research - FINAL
GCP and Conduct in Clinical Research - FINAL
 
Getting Biopharmaceutical Production Processes Right the First Time
Getting Biopharmaceutical Production Processes Right the First TimeGetting Biopharmaceutical Production Processes Right the First Time
Getting Biopharmaceutical Production Processes Right the First Time
 
Study 5: Pre-commissioning Safety Review
Study 5: Pre-commissioning Safety ReviewStudy 5: Pre-commissioning Safety Review
Study 5: Pre-commissioning Safety Review
 
2015 Fawzy Hassan CV+ pro+train
2015 Fawzy Hassan CV+ pro+train2015 Fawzy Hassan CV+ pro+train
2015 Fawzy Hassan CV+ pro+train
 
The Bioprocessing Summit 2014 Agenda
The Bioprocessing Summit 2014 AgendaThe Bioprocessing Summit 2014 Agenda
The Bioprocessing Summit 2014 Agenda
 
Research unit for Biosciences UMONS
Research unit for Biosciences UMONSResearch unit for Biosciences UMONS
Research unit for Biosciences UMONS
 
Tab-inj-semi
Tab-inj-semiTab-inj-semi
Tab-inj-semi
 

DR SUMANT CONSULTANCY Dec

  • 1.
  • 2. 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
  • 3. Training Fee : 25,000 to 1,25,000 INRTraining Fee : 25,000 to 1,25,000 INR Individual / Group Training: ONSITE/OffSITEIndividual / Group Training: ONSITE/OffSITE
  • 4. Market Projection/Licensing …350 to 2000USDMarket Projection/Licensing …350 to 2000USD  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
  • 5. 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.
  • 6. 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.
  • 7. 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
  • 8. Technical Position Held,Technical Position Held,  SENIOR GROUP LEADER FERMENTATION AND SYNTHESIS R & D AT CONCORD BIOTECH LIMITED ◦ TACROLIMUS,SIROLIMUS,STATINS(LIPSTATIN,PRAVASTATIN,LOVASTATIN),DAPT OMYCIN,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
  • 9. 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
  • 10. Product handled till now…..Product handled till 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
  • 11. 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
  • 12. Market Analysis/projection clients-Market Analysis/projection clients- 2013-152013-15  IMS – Mumbai Office  Smart cube  Markets and Markets  Beroe  Insight Alpha  Infolin  Precision Advisors,55 Cambridge Parkway, Suite 300E   ETC
  • 13. 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 Biologics Recombinant 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.aspx 3. Bioprocess India -2014 ,http://www.bioprocessingindia.org/speakers.html Blog : https://blog.zintro.com/2015/02/10/competition-affecting-big-pharma/
  • 14.  Thank you so much for connecting to DSC Bioprocess consultancy service.  You can reach any time to me at,  sumant.biopharmaexpert@gmail.com Sumant.msu@gmail.com  skype: sumant.chaubey  whatsapp : 00(+91)-9036992907  contact number ; 00(+91)-9898639929