Biologics,Biological,Biobetter,Biosimilar

2. 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.

3. 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.

4. 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

5. 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

6. 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

7. 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

8. Clientele list …..Clientele list …..
INTERNATIONAL CLIENTS
Company Product Consultancy Project Cost
1 Client 1,Tehran Erythropoetin –
alpha and Beta
Undisclosed/ Year
2 XXgen Co,Tehran Tacrolimus Share basis(undisclosed)
3 XX Co,Tehran Sirolimus Share Basis
INDIAN CLIENTS
4 BBPL,Vadodara Tacrolimus &
Orlistat
Undisclosed
5 KMS / MTR, Chennai r-PTH,r-Glargine Undisclosed
6 XXXBioscience,Hyderabad Biologics Process Share Basis
7 Private Ltd,XXX Preclinical for
Biosimilars
Share Basis

9. 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/

10.  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