1. Seshu K. Gudlavalleti
1
11321, Decatur plaza, Apt#807 Omaha, NE 68154
Ph: 404-388-5099(Cell), email: sgudlav@gmail.com
US citizen.
Education: PhDin Life Sciences(Microbial Biochemistry) fromJawaharlal NehruUniversity
NewDelhi,India,in2001. Work done at Centerfor CellularandMolecularBiology(CCMB),
Hyderabad,India.
Postdoctoral experience
1) 2005-2007, CBER/FDA,Bethesda,MD, supervisors:DrCarl Frasch and Dr Willie FVann
2) 2002-2005, Emory University,Atlanta,GA, supervisor:Dr DavidS Stephens
3) 2000-2002, CCRC/UGA Athens, GA,Supervisor:Dr. LennartS Forsberg
Industryexperience:
1. Two yearsof Bio-analytical ScientistatSESIInc. surface proteomics.
2. Currentlyworking(sinceOctober2009) at JN Medical CorporationasChief Scientist
(conjugate vaccines)
Review experience: Reviewerfor journals Vaccine,Analytical ChemistryandLife Sciences
Group. Editorial boardmemberof WorldJournal of Experimental Medicine’.
US Patent:# 7883,876 (serial No.11/943,326). ‘ Neisseriameningitidis serogroupA capsular
polysaccharide acetyltransferase,methodsandcompositions.
Knowledge, Skills and Abilities: GLP production/purification/assay development on
mening polysaccharide-diphtheria toxoid conjugate vaccines. Preparation of SOPs,
process work sheets, CMC, review of pre-clinical and clinical protocols. Polysaccharide
SEC for purity and characterization. Colorimetry, ELISA, HPLC/UPLC, column
chromatography assay development. Bacterial Surface proteomics, polysaccharide
chemistry, Polysaccharide biosynthesis, Polysaccharide-protein conjugate vaccines,
Bacterial membrane proteins, Protein expression in bacterial vectors, Protein
characterization, Bacterial molecular taxonomy. Gene knockout in bacteria, gene
identification, novel enzyme assay development.
Skills: Polysaccharide-protein conjugation chemistry, conjugation vaccine making,
polysaccharide manufacture,purificationusing column chromatography, HPLC characterization
of vaccines, mass spectrometry of small molecules and peptides, 1
HNMR of polysaccharides,
UPLC, HPLC,(AcquityHWaters/Empower2) HPAEC, ELISAs of polysaccharide-protein conjugate
vaccines , serum bactericidal activity assays, identifcation of bacterial surface proteins and
vaccine candidates using whole cell AP-MALDI, (atmospheric pressure- matrix assisted laser
desorptionionization) mass spectrometry, MALDI-TOF of lipid A (2 yrs),GC of fatty acid methyl

2. Seshu K. Gudlavalleti
2
esters, GC-MS of polysaccharide/ lipid A (5 yrs), lipid A and polysaccharide NMR (2 yrs),
polysaccharide HPAEC (DIONEX)- (2 yrs). Lipid A TLC, SEC, of polysaccharides, Gel
electrophoresis(7yrs),.Polysaccharideproduction,purification, conjugation chemistry, protein
and polysaccharide chemical estimations, mice injections, antisera collection and ELISAs,
inhibition ELISAs, bacterial colony immunoblots, cell surface hydrophobicity measurements,
serum bactericidal activity assays. Protein expression- novel assays developed, designed
primers,cloned,expressedandpurified meningococcal capsule biosynthetic proteins in E. coli.
Immunology- Inhibition ELISAs, bactericidal activity assays, Colony Immunoblots, westerns on
proteins and CPS. NMR-analyzed CPS and lipid A molecules. ABI-PRISMDNA sequencing (1yr).
Empower2 on HPLC, UPLC Excel, Powerpoint, word, Photoshop, outlook Chemdraw, MASCOT
analyses, protein MS/MS based homology search, BLAST search.
Summary of Work Experience:
Currentwork:Chief Scientist,JN-International Medical Corporation, 2720 N 84th
St, Omaha, NE
68134. Since 1st
October 2009.
Duties: Making meningococcal A/C/W135/Y PS-DT conjugate vaccines at GLP and now scale up
cGMP conditions.Designedprocesstoachieve highqualitypolysaccharides to make tetravalent
conjugate vaccine withlatest conjugation methods. Designed quality control assays for PS size
estimations, NMR profiling (at UNMC NMR facility) and HPLC SEC/reverse phase runs.
Writing/approving and implementing process work sheets, SOPs in coordination with QA/QC.
Purification of polysaccharides by gel-filtration and HIC chromatography. Making conjugate
vaccines, purification and characterization by colorimetry, UPLC/HPLC (Waters, Empower
software) and NMR. Research on both lab scale and scaling-up strategies. Written
CMC(chemistry, manufacture and control) for IND, SBA and animal protocols for pre-clinical
studieson the meningconjugate-vaccineproject. Attended pre-IND meeting with FDA. Helped
making Pre-clinical and clinical protocol. Monitoring pre-clinical studies on test material
prepared under my supervision. Currently working closely on scaling up strategies with
fermentation engineers.
Previousexperience:
15th
May 2007 to 26th
May 2009 as Bioanalytical Scientist, Science and Engineering Services,
Inc. 6992, Columbia Gateway Drive, Columbia, MD 21046, Identification of bacterial spores,
vegetative cells, viruses and toxins by MALDI MS/MS.
2 years inpolysaccharide-proteinconjugate vaccine researchatCBER/FDA.
2 ½ years in Neisserial CPS biosynthetic gene identification and protein expression at Emory.
2 years in LPS chemical structure elucidation at CCRC/UGA,
7 years in bacterial protein biochemistry at CCMB, India.
5 years in microbial molecular taxonomy at CCMB, India.

3. Seshu K. Gudlavalleti
3
Publicationsand patents: 18 Intl.Publications,4firstauthored,1 US patentin process. 1 book
chapter, 1 paperisjust communicatedandone inmanuscriptpreparation.
Recent experience 1
AP-MALDI (atmospheric pressure- matrix assisted laser desorption ionization) mass
spectrometry to identify microbes from aerosol concentrates after high-throughput sample
processing and concentration by microfiltration. The spotted sample processed on-probe for
enrichingspecific bacterial or viral surface proteins. Trypsin digests were further subjected to
AP-MALDI MS and thenusingMASCOT proteindatabase analyses to identify bacterial and viral
samples.Identifyingantibioticresistance in E.coliusingproteomicmethods.IdentifiedInfluenza
A specificbiomarkerpeptides.Identified hydrazide adduct peptides in carbodiimide mediated
hydrazine activated BSA.
Previous Experience 2
From 25th
April 2005 to May 2007 hired by ORAU (Oak Ridge Associated Universities) in the
Research Fellowship Program at the Center for Biologics Evaluation and Research (CBER), U.S.
Food and Drug Administration (FDA) at Bethesda, MD, USA in the meningococcal vaccine
development project. Responsibilities include using conjugation chemistry to develop
meningococcal polysaccharide-protein conjugate vaccines and test their efficacy. Screening
clinical isolatesforpolysaccharide(PS) yieldandepitope specificity. Work involves PS isolation
by CTAB method and purification. Test the purity by NMR and colorimetric assays for the
presence of monomeric sugars and O-acetyl epitopes. Activation of polysaccharide chemical
methods such as (especially) periodic acid oxidation and CDAP chemistry and activation of
protein by hydrazide chemistry and conjugation of these activated species. Looking at the
monomer oxidation by DIONEX HPAEC-ECD. Test conjugates for their size by HPLC and MALLS
and specificity by ELISAs. Injection of mice for antibody production and subsequent ELISAs,
inhibition ELISAs and bactericidal activity assays to measure the specificity and efficacy of the
PS-proteinconjugatevaccines.The conjugateswere sizefractionated by S400 sephacryl column
to obtain large molecular species to identify the levels of unconjugated PS.
Attended and successfully completed ‘New reviewers training on FDA vaccine regulations
during December 12-15th
2005.
Previous experience 3
From1st
July 2002 to April 25 th
2005 worked as postdoctoral fellow at Emory University School
of Medicine, department of Medicine, division of Infectious Diseases, Atlanta GA in an NIH
funded project on ‘Pathogenesis of Neisseria meningitidis’. Identified the O-acetyltransferase
gene of capsular polysaccharide biosynthetic path way in mening serogroup A . This work
involvedgenetic knock outs by kanamycin cassette insertion and identification of functions of
CPSbiosyntheticgenes.Cloning of the non-homologous genes in bacterial expression vectors,
expression and purification by Ni NTA affinity chromatography. Localization of the O-

4. Seshu K. Gudlavalleti
4
aceyltransferase. Developed novel assay method to identify the function of novel enzyme in
serogroup A. Successful collaboration with NRC, Canada for whole cell NMR observation to
determine CPSin vivo.AppliedforUSpatentonthe recombinantOAT.Undertakencollaborative
works withCDC, Atlanta,supervisedtechnical staff at the laboratory of David Stephens, during
postdoctoral work at Emory University.
Previous experience 4
Two years of postdoctoral experience (June 2000 to June 2002) at Complex Carbohydrate
Research Center, UGA, Athens GA (www.ccrc.uga.edu) prior to joining Emory University.
Worked on a USDA funded project on ‘Structural elucidation of lipopolysaccharides (LPS) of
Sinorhizobial strains”. This work involved large scale (100 lit fermenter batches) bacterial
growth,LPS isolationby phenol- water extraction and purification by SEC manual columns and
HPAEC-DIONEX and chemical characterization of LPS from sinorhizobial strains. Elucidated the
structure of lipid A molecule from NGR234 strain using MALDI-TOF, TLC, NMR, GC-MS and
HPAEC.
List of selected publications:
1. ‘Quantificationof eachserogroupPolysaccharide of Neisseria meningitidis in A/C/Y/W-
135-DT conjugate vaccine by High Performance Anion-Exchange Chromatography-
Pulsed Amperometric Detection Analysis’. Seshu Kumar Gudlavalleti, Erika Nicole
Crawford, Jeffery David Harder, and Jeeri Raghava Reddy. Anal. Chem., 86 (2014) (11),
pp 5383-5390.
2. ‘Determining trace amounts and the origin of formaldehyde impurity in Neisseria
meiningitidis A/C/Y/W-135-DTconjugate vaccine formulatedinisotonic aqueous 1x PBS
by improved C18-UPLC method’. Seshu K. Gudlavalleti, Erika N. Crawford, Nhi N. Tran,
Dana J. Orten, Jeffery D. Harder and Jeeri R. Reddy. Journal of Pharmaceutical and
Biomedical Analysis. 107 (2015) pp 432-436.
3. ‘UPLC Determinationof processimpurityhydrazine in Neisseria meningitidis A/C/Y/W-
135-DT conjugate vaccine formulatedinisotonicaqueous1x PBS’.SeshuK.Gudlavalleti,
Derek A. Leas and Jeeri R. Reddy. Journal of Pharma and Pharmaceutical Sciences 1(2)
2015 pp12-16.
4. ‘Applicationof AtmosphericPressureMatrix-Assisted Laser Desorption Ionization Mass
spectrometryforRapididentificationof Neisseriaspecies’.SeshuK.Gudlavalleti,Appavu
K.Sundaram, Jane Razumovski and Vladimir Doroshenko. Journal of Biomolecular
Techniques (2008) 19:200-204
5. ‘Comparison of W135 polysaccharide-tetanus toxoid conjugate vaccines made by
periodate activation of naturally O-acetylated, naturally non-O-acetylated and
chemicallyde-O-acetylatedpolysaccharides’.SeshuK.Gudlavalleti,Che-Hung Lee, Scott
E. Norris,ManeeshPaul-Satyaseela, Willie F.Vannand Carl E. Frasch. Vaccine 25(2007)
7972-7980

5. Seshu K. Gudlavalleti
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6. ‘In Vivo determinationof Neisseria meningitidis SerogroupA capsular polysaccharide by
whole cell high resolution magic angle spinning NMR spectroscopy.’ Seshu K.
Gudlavalleti, Christine M. Szymanski, Harold C. Jarrell, and David S. Stephens
Carbohydrate Research(2006),Volume 341, Issue 4, Pages 557-562.,
7. ‘The Neisseria meningitidis serogroup A capsular polysaccharide O-3 and O-4
acetyltransferase Seshu K Gudlavalleti, Anup K Datta, Yih Ling Tzeng, Corie Noble,
Russell W. Carlson and David S. Stephens. (2004). J. Biol. Chem. 278: 42765-42773.’
8. Structural Characterization of the lipid A Component of Sinorhizobium sp. NGR234
Rough and smooth Lipopolysaccharide. Demonstration that the distal amide linked
acyloxyacyl residue containing the long chain fatty acid is conserved In Rhizobium and
Sinorhizobium spp.(2003) Seshu K. Gudlavalleti and Lennart S. Forsberg J. Biol. Chem
278: 3957-3968.
9. ‘Biofilm Formation by Neisseria meningitidis.’ Kyungcheol Yi, Andrew W. Rasmussen,
Seshu K. Gudlavalleti, David S. Stephens, and Igor Stojilkovic (2004). Infection and
Immunity 72: 6132-6138.
10. ‘Phosphorylation of lipopolysaccharides in the Antarctic psychrotroph Pseudomonas
syringae: A possible role in temperature adaptation’. Ray, M.K., Seshu Kumar, G. and
Shivaji, S. (1994) J. Bacteriol. 176: 4243-4249.
Book chapter:
S.K. Gudlavalleti, S.B. Stevens, B.L. Reuhs, L.S. Forsberg. 2002. Sinorhizobium sp.
Strain NGR234 lipolysaccharides: structural features and comparison of LPS from
uninduced and apigenin-induced cells.. In: Nitrogen Fixation: Global
Perspectives,Proceedings of the 13th hInternational Congress on Nitrogen Fixation
(T.M. Finan et al., eds), pp. 525. CABI Publishing
Selected Conferences and presentations:
1. Attended Waters Vaccine summit during April 28-30 2010, Milford, MA USA.
2. ASMS 2009 Philadelphia : Proteomics approach for the identification hydrazide
addition peptides by using APMALDI MS/MS: poster
3. ASMS 2008 Denver: Application of APMALDI MS in rapid identification of
Neisseria sp. Poster
4. “Meningitis and Septicaemia in Children and Adults” meeting at The Royal
Society of Medicine, London, UK 2005 “Meningococcal serogroup W135
polysaccharide-tetanus toxoid conjugate vaccines”. Poster
5. Pathogenic Neisseria Conference at Milwaukee, Wiskonsin, during September 5-
10, 2004. ‘The Neisseria meningitidis serogroup A Capsular Polysaccharide O-3
and O-4 Acetylatransferase’ Poster
6. ASM ‘Southeastern and South Carolina Branches meet during Oct. 30- Nov. 1,
2003‘The identification of the Neisseria meningitidis serogroup A capsular
polysaccharide Acetyltransferase’. Oral
7. 18th North American Conference on Symbiotic Nitrogen Fixation held at
University of Missouri, Columbia, Missouri, USA during June 3-8, 2002

6. Seshu K. Gudlavalleti
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Apigenin induction of Sinorhizobium sp.NGR234 cells in vegetative culture
causes a shift from rough-LPS to a smooth-LPS containing a rhamnan O-chain
and a structurally modified core-lipid A. Poster
8. 13th International congress on Nitrogen fixation McMaster University, Hamilton,
Ontario, Canada (July 2-7,2001) Structural comparison of lipopolysaccharides
and lipid A components from Rhizobium etli CE3, Sinorhizobium NGR234.
Poster.
References:
1. Dr. Willie F. Vann,
Chief, Laboratory of Bacterial polysaccharides
CBER/FDA Building 29, Lincoln Drive Bethesda, USA 20892
Phone Number: (301) 496-2008
Email: willie.vann@fda.hhs.gov
2. Dr Carl E. Frasch
Retired Chief of Laboratory of PS, CBER/FDA
Email: cfrasch1@juno.com Phone: 3042795011
3. Prof. David S. Stephens, MD
Director, Division of Infectious Diseases Research Services (151-I), Department of Veteran
Affairs Medical Center 1670 Clairmont Road, Decatur, GA 30033, Tel 404-728-7688 Fax: 402-
329-2210. Or Department of Medicine, Emory University School of Medicine69 Butler Street,
S.E. Atlanta, GA 30303 Email: dstep01@emory.edu
4. Dr. Lennart S. Forsberg
Research Biochemist
Complex Carbohydrate Research Center
315 Riverbend Road, University of Georgia
Athens,GA 30602. TEL 706-542-4479
FAX 706-542-4412
email sforsb@ccrc.uga.edu