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
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