Mr. Nagaprasad Arepally is summarizing his objective and qualifications for a career in biotechnology focusing on process optimization, scale up/down activities for recombinant microbial protein expression and E.coli fermentation. He provides his academic credentials including an M.Sc. in Microbiology and B.Sc. in Biotechnology, Chemistry, and Zoology. He also lists his previous work experience of over 17 years at various organizations working in roles such as Executive, Research Scientist, and Manager focusing on fermentation technology. He has handled over 19 projects from R&D to production scale involving fermentation of organisms such as E.coli, yeast, and bacteria. He provides details of his expertise in

1. Mr. NAGAPRASAD AREPALLY
1

2. 2
1. Objective & Academic credentials
2. Personal details
3. Previous Organization details (Experience)
4. Projects handled (R&D, PILOT & Production scale).
5.Professional Skills.
6. Instruments Handled.
7.Audits faced.
8. Question & answers?

3. 3
*Hono ed university first in B.Sc. I st year in Biotechnology subject.
Objective:
In pursuit of a career focused on emerging frontiers of biotechnology,
involving process Optimization, scale up/down activities for Recombinant
Microbial protein expression followed by E.coli fermentation technology at
R&D, Pilot & Production scale. Knowledge on validation aspects for Old &
New equipments, new facility, Clean Utilities etc.
Academic credentials:
*
S.No
r
Name of the Degree University
Year of
completion
1 M.Sc.-Microbiology Bharathidasan 2002
2
B.Sc.- * Biotechnology,
chemistry & zoology Andhra 2000
3 Bi.P.C
Board of
intermediate 1996
4 SSC
AP board 1994

4. 4
Father’s Name : Bangar Rao (Late)
Date of Birth : 04.01.1979
Marital Status : Married
Sex : Male
Nationality : Indian
Linguistic Skills : Telugu, English & Hindi
Pass port no : K 1829983
Dependents : 03 ( spouse & 2 kids)
Publications:
DESIGN, FORMULATION DEVELOPMENT AND IN VITRO
EVALUATION OF MUCOADHESIVE TABLETS OF
CLOTRIMAZOLE-β CYCLODEXTRIN COMPLEXES.
[Naga Prasad Arepally. et al. / Asian Journal of Research in
Chemistry and Pharmaceutical Sciences. 1(2), 2013, 48 – 58] .

5. 5
(Previous Organiations Experience…… 17 + years)
S.No Name of the
organization
Designation Duration Reporting to Team
size
1
Biological
Evans Limited
Sr. Executive
May 2003 to
April 2007
Manager-
Production
NA
2
Scigen Biopharma Sr. Executive May 2007 to
May2008
Production –
Head
NA
3 Wockhardt R&D
Research
Scientist
June 2008 to
May 2010.
Associate
Director 03
4
Virchow biotech
private limited
Manager-
fermentation
June 2010 to
Aug 2011
Director
(Technical)
14
5
Shantha Biotechnics
limited (A sanofi
company)
Manager-Pilot
facility
Sep 2011 to
May 2015
AGM-MTECH
Dept., 12
6 NANOGEN
BIOPHARMACEUTICAL
(VIETNAM)
Head-E.coli
fermentation
technology
June2015 to
Till date
MD & CEO-
Dr. Ho Nhan 26

6. 6
E.coli Fermentation technology & Purification process till the end
of API ( 19 + projects handled…till date)
S.No Name of the project Scale Organism’s handled
1 Diphtheria, PDGF-BB, IFN-
2B, PTH, Insulin, Glargine,
Carboxypeptidase-B,GCSF.
Production Scale E.coli-(recombinant),
Wild bacterial strain, Yeast.
2 DBT---- r-Enfuvirtide,
Exendine, BMP-2.
R&D and Pilot
scale
E.coli-(recombinant)
3 Urate Oxidase, cholera,
Lispro, Aspart.
Process
development
E.coli-(recombinant)
4 HPV R&D E.coli-(recombinant)
5 nCOVID-19: CR3022, B38
& H4 antibodies fg
R&D E.coli-(recombinant)

7. 7
Fermentation Technology (E.coli):
Process development, process Optimization and scale-up of yeast and bacterial
fermentations.
Media preparation & Optimization for Fermentation.
Sterilization of bioreactors(ESIP & FSIP)
Organisms handled: E.coli, H.polymorphia and C.diphtheria
Upstream process:
Mid stream processing of fermented broth for the recovery and purification of
proteins by cell lysis, centrifugation and ultra filtration (TFF) methods.
Washing of Inclusion Bodies.
Induction Strategies.
Media optimization, Fermentation hour’s optimization.
Estimation of Glucose, Acetate, generation time and Plasmid stability.
Analysis of Biomass achieved, Mass balance calculation based of Carbon source
consumption.

8. 8
Validation Activities:
Preparation of URS for Facility & Equipment's.
Preparation of Documents such as SOP’s, IQ, OQ & PQ pertaining to
equipment's & facility.
Execution of validation activities for Equipment's and facility.
Cleaning validations for the Equipment's and process.
Molecular biology:
Preparation of Glycerol stocks- MCB &WCB.
Characterization studies for Host and fermentation samples.
Preparation of Competent cells.
Plasmid stability analysis.

9. 9
Fermentors: B-10, C-20, C-30, D-100, D-750 B.Braun fermentors& 1250 lts Scigenics
fermenter.
Cell disruptors: Dynomill: 6 liters, 2L and 500ml capacity, High Pressure
Homogenizers (max. 1000bar).
Centrifuges: Continuous Centrifuge: Heraeus & Alfa Laval, Batch & Ultra
Centrifuges: Avanti and Beckman.
Cross-flow Systems: Micro filtration and Ultra Filtration systems.
Concentration and Diafiltration with 0.22µ, 0.45µ, 10KD, 30KD, 100KD and 300KD
cassettes – Millipore, Pall and Sartorius.
Micro filtration & Ultra filtration with ceramic membrane for concentration and
Diafiltration – Nishotech systems, Dead-end filtrations & Pad filtration.
Spectrophotometer.
pH meters, Conductivity meters, Watson-Marlow pumps, Master flex Pumps and
Millipore TFF skids.
CIP and SIP Skid, Shaker Incubators and -200C & -700CFreezers.
Millipore Water Purifier System, Millipore Cogent TFF systems.
Integrity testing of hydrophilic & hydrophobic filters by using Sartocheck 4 plus.

10. 10
Actively Participated in the following audits:
Lead the production team during ANVISA, Brazil audit in 2011.
GQA – External & InternalAudits.
Customer audits: Zelos Therapeutics Inc. (as per US-FDA norms), Bergamoand
EMS pharma (according to Brazilian GMP regulations), ADOCIA Biotech (as
per EMA regulations).
ISO audits,
WHO-GMP audits from DCGI,
Nigerian drug authority,
Egyptian drug authority,
Kenyan drug authority,
Ethiopian regulatory authority,
Ghana Republic drug authority.
PIC/S UKRAINE.

11. 11
Thank You