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Quality Control Development

Location:
Hyderabad, AP, India
Posted:
January 24, 2014

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Resume:

CURRICULUM VITAE

BALA OBULAPATHI BANDI Mobile: 950-***-****

Email: accbcj@r.postjobfree.com

Dear Sir,

I introduce myself as B.Balaobulapathi, working as an Executive -Vaccine Process Development,

for Indian Immunologicals limited.

With 5.10 years of significant exposure in research functions & Quality control related to cell

culture -viral vaccines, I possess a clear understanding to industry, technology trends with

distinction of instituting quality techniques and demonstrated competence in bioprocess

development.

I am confident that I can be an asset to your company and would appreciate your reviewing the

enclosed resume for any suitable post in your organization.

Looking forward to hearing from you.

Sincerely,

B.Balaobulapathi

PROFESSIONAL EXPERIENCE:

Industry: 5.10 years in Research and development & Quality control

WORK EXPERIENCE IN R&D:

• Dynamic Professional with 5.10 years of experience in Cell Culture, virus culture and

viral purifications.

• Establishment of laboratory set up for performing sterile cell culture functions as per

cGMP.

• Maintenance,characterization, cryopreservation of Various Mammalian, Insect and

Avian cell lines (Suspension & Adherent) such as CHO-DG44,MRC-5, CHO-dhfr-, VERO,Sf9,

293TT, BHK-21, QT-35, MDCK,COS-7 etc. Cancer cell lines like HELA, SIHA, HL-60, C-33a

etc.

• Transient and stable transfections of mammalian cells like CHO-DG-44,HEK

293TTusing different methods(Lipofectamine & Freestyle Max Reagent .

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• Cell based assays like Indirect Immunofluorescent Assay, Antibody Neutralization assay,

cell viability assays.

• Hands on experience in process development of vaccines –Rabies, Hepatitis-A,

chikungunya & Japanese encephalitis

• Preparation of chikungunya & Japanese encephalitis antigen for raising antiserum in animal

models and its standardization for use as an Internal Reference Standard (IRS).

• Significant exposure to fermentation, media optimization and primary purification.

• Up scaling of various Mammalian cell lines, viruses and preparation of Master, working

banks & Characterization of cGMP viral & cell banks

• Preparation of Media & sterilization by filtration.

• Viral concentration and diafiltration by TFF.

• Development and standardization of immunoassays like Direct & Indirect ELISA, SDS-

PAGE, and Immuno blotting.

• Affinity purification of monoclonal antibodies by Protein A / G affinity chromatography.

• Immortalization of primary cells of human liver and dog kidney origin.

PROJECTS HANDLED:

• Adaptation, propagation, plaque assay, TCID50, characterization & bank preparation of

Human viruses like Rabies, chikungunya, JEV and Hepatitis –A.

• Development of stable cell lines Expressing anti-rabies Monoclonal antibody in CHO-

DG44 cells

• Isolation, propagation & Immortalization of primary canine kidney cells & human

hepatocytes by using retroviral gene.

• Preparation of cGMP Master cell lines & virus banks.

• Adaptation of VERO, MDCK and BHK cell lines to serum free medium & up scaling in

rollers, fibrastage culture systems.

• Adaptation of CHO cell line for growth in suspension using serum free medium and spinner

flasks.

• Evaluation of Recombinant trypsin in comparison with conventional trypsin for

disaggregation of various cell lines.

CHARACTERIZATION OF CELL LINES:

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• Iso-enzyme Analysis.

• Screening for adventitious agents by Indirect FAT.

• Screening for Mycoplasma sp by PCR.

• Screening for bacteria and Fungi.

PRIMARY CULTURE:

• Preparation of Primary organ culture cell line – Chicken Embryo Fibroblast (CEF).

• Isolation and maintenance of Dog kidney cells.

• Isolation and culturing of PBMC from mouse spleen and blood.

WORK EXPERIENCE IN QUALITY CONTROL:

• Working as Executive-QC for viral vaccines.

• Working as in-charge for stability studies for viral vaccines.

• Working in Chickungunya and Japanese encephalitis vaccine testing for development and

pilot scale studies.

• Regular Analysis and Monitoring the Quality control tests for viral vaccines.

• Preparation of Product release Specifications, COA’s and Test methods as per

Pharmacopoeial and Regulatory Norms.

• Preparation of Analytical method Validation Protocol and Conducting Method validations as

per ICH Guidelines.

• Preparation of protocol and conduction of Stability Studies (Real time, Accelerated &

Stressed), Trend analysis and evaluation as per ICH Guidelines on intermediates, Final bulk

and finished product vaccine.

• Maintenance of Quality Control Lab as per WHO, GLP& cGMP Standards.

• Member of Internal Audits Team.

• Preparation and review of documents like STPs, SOPs, RSTs, validation protocols,

Equipment URS and other related documents.

• Preparation of Monthly and Quarterly reports.

• Preparation Execution of Analyst qualification protocol for qualifying analyst.

BIO ASSAYS & CELL CULTURE:

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• Determination of virus concentration by plaque assay in process samples, finished product

samples.

• Plaque reduction Neutralization test (PRNT) to Estimation antibody response for

Chickungunya and Japanese Encephalitis samples.

• Cell culture Innocuity testing for Chikungunya, Japanese encephalitis & Rabies vaccines.

• Determination of Rabies antibody content by Rapid Fluorescent Focus Inhibition Test

(RFFIT).

• Preparation of Rabies Challenge virus strain master bank and working bank in MNA cells.

• Standardization of In house reference virus standard with International reference standard.

• Extraneous agents testing (for viruses) in cell lines.

ANIMAL HANDLING:

• Adequately trained in handling of laboratory animals (mouse, rabbit and guinea pig)

Immunization of laboratory animals through various parenteral routes.

• Titration of animal viruses and optimization of serum neutralization test both in vitro using

cell culture (SNT) and in vivo using mice (MNT).

PUBLICATIONS:

1. Assessment of packed bed bioreactor systems in the production of viral vaccines

R. Ramya1a, Rajendra Lingala1a, Siva Kumar Vuppu1, Bala Obulapathi Bandi1, M.Elaiyaraja1,

Sankar Rao Macherla1, Stéphanie Dubois2, Nicolas Havelange3, Kapil Maithal1

2. Identification of cross-contaminated animal cells by PCR and isoenzyme analysis.

Cytotechnology 61: 81-92.

Ramya R., Nagarajan T., Sivakumar V., Senthilkumar R.L., BalaObulapathi B., Thiagarajan

D.Srinivasan V.A. (2009).

3. Standardization of an ELISPOT protocol for the Evaluation of Human papillomavirus

16 (HPV16) E7

Specific T cell response in mice immunized with the E7 recombinant Salmonella typhi

strain Ty21a (S.typhi Ty21a)

Current Trends in Biotechnology and Pharmacy

Vol. 6 (4) 479-488 October 2012, ISSN 0973-8916 (Print), 2230-7303 (Online)

Ponnanna NM1, Rajan Sriraman1, Ravi Ranjan Verma1, Balaji Kasa1, Kota Sathish1,

Maroudam V1, BalaObulapathi1, M Lakshmi Narasu2 and VA Srinivasan1

STRENGTHS:

• Working in a team environment with fast and perfect hands on skills.

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• Designing the experiments and troubleshooting. Through knowledge and experience in

GMP environment.

• Ensuring for compliance for quality systems as per cGMP. .

EDUCATION:

• Master of Science (Microbiology) from Sri Krishnadevaraya University. (2005 – 2007)

• Bachelor of Science (Medical Lab Technology) from Sri Venkateswara University. (2002

– 2005)

PERSONAL PROFILE:

Name : B.Bala Obulapathi

Fathers Name : B.Naganna

Date of Birth : 01.07.1982

Nationality : Indian

Marital Status : Married

Languages Known : English and Telugu

ADDRESS FOR CORRESPONDENCE:

B.Balaobulapathi,

C/O RP Tripati,

H.NO: 2-31/1/81,

Shivajinagar colony,

Serilingam palli.Hyderabad

Declaration:

I hereby declare that the information furnished above is true to the best of my

knowledge and belief.

Date: (B.Balaobulapathi)

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