M. Manoj Kumar

Projects Handled

• Working in Analytical Science department for Penta and Hexavalent vaccines .
• Purification, process development and characterization of HIB polysaccharide vaccine.
• Amino acid estimation in the milk protein (NZ case TT)
• Raw material identification by advanced spectroscopy methods like NIR, RAMAN & XRD
• Amino acid sequencing and peptide mapping and also molecular weight of the proteins determination by LC-MS (Agilet Q-TOF)
• Quality Systems:
• Preparation of Standard Operating Procedures (SOP) according to C-GMP
• Preparation of Protocols, Method development reports & Qualification reports
• Process validations and IQ, OQ & PQ for Qualification of Instruments
• Preparation of R n D Reports and Memos for submission to FDA authorities
• Involved in method familiarization and method validation with Quality control department

Projects Handled

• Analytical development and optimization of 15 valent protein conjugate vaccines.
• Development and optimization of methods for Protein Characterization
• UV-MALS RI system to characterize the conjugated proteins, polysaccharides and aggregated proteins.
• Operation of SE-HLC with the use of PDA and RI detectors for characterizing the proteins and polysaccharides.
• Operation of RP-HPLC for checking the purity of the Recombinant proteins
• Involved in Pertussis validation process.
• Preparation of Standard Operating Procedures (SOP) according to C-GMP and write the internal protocols

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Projects Handled

• Worked on H1N1 protein (Protein estimation,SDS-PAGE & IEF)

• Projects Handled:
• Analytical development and optimizations of 15 valent protein conjugate vaccine
• Development and optimization of methods for protein Characterization
• Method development for PRP-T (Protein conjugates) samples by using MALS (Multi Angle Light scattering) detectors in Shan 6 project
• Protein estimation and polysaccharide estimation by microplate assays

Industrial Training :

Trained on Development and optimization of analytical methods for protein characterization from March 2006 - July 2006

• UV MALLS –RI system to characterize conjugated proteins, polysaccharides and aggregated proteins
• Operation of SE-HPLC with the use of PDA and RI detectors for characterizing the proteins and polysaccharides
• Operation of RP-HPLC for checking the purity of the Recombinant proteins
• Amino acid estimation in the milk protein (NZ case TT) by UPLC
• Raw material identification by advanced spectroscopy methods like NIR, RAMAN & XRD
• Amino acid sequencing and peptide mapping and also molecular weight of the proteins determination by LC-MS (Agilet Q-TOF)
• DIONEX for free PRP estimation
• Reduce the molecular size of Polysaccharide by Homogenization method
• Estimation of the proteins by Lowry, Bradford and BCA methods
• Estimation of polysaccharides by Anthrone and Orcinol methods
• Free polysaccharide estimation by DOC method
• Iso electric focusing (IEF) to check the pI of protein
• Protein characterization by SDS-PAGE and Western blotting
• TFF system for concentration of proteins and polysaccharides,
• Endotoxin estimation by LAL test
• LF test for knowing the LF content of Ag
• 10L fermentor operation
• Operation of the Spectrophotometer (UV, visible, double beam)
• GC-MS used for the volatile substance quantification
• LC-MS the amino acid sequencing and antigen identification and to know the Protein mass by charge ratio and peptide mapping
• Circular Dichroism & Fluorescence for the Protein secondary structure identification and to find out α helix, β-sheets
• Dynamic light scattering (DLS) to know the protein Z-Average size and shape and also its hydro dynamic radius (Rh) in nanometers
• Malvern Zeta sizer to know the protein Z-Average size and shape and also irs RMS radius
• DSC (Differential scanning colorimeter) used for the Protein Melting point and exactly where (Maximum temperature) it is (Tm) denaturing