Problem Solver
Dr.Shivraj Dasari
Areas Dr.Shivraj Dasari is Knowledgeable in:
Recombinant Monoclonal Antibodies, VAccines, Any aspect of Quality MAnagement Systems, process development including fermentation, down stream processing, fill finish and stability studies of recombinant proteins.
Molecular diagnostics of infectious diseases, genetic diseases, Biomarkars.
Stemm cells isolation, culturing, characterization by flow cytometry, from different sources like cord blood, Bone marrow, wharton jelly, dental pulp.
Molecular diagnostics of infectious diseases, genetic diseases, Biomarkars.
Stemm cells isolation, culturing, characterization by flow cytometry, from different sources like cord blood, Bone marrow, wharton jelly, dental pulp.
Techniques Dr.Shivraj Dasari Uses:
While working as Head of Quality deptt, I have successfully reduced the losses in fill finish of Hepatitis vaccine from 22% to less than 2%. I have also introduced a pilfer proof packaging for the multidose vials. Developed the 2 dimensional barcoding and holograms for ensuring the security of the products during supply chain management.
My ability to lead a diverse team to increase the yield of Monoclonal antibody by 94% during the tech transfer and process development phase.
Successfully developed a semi quantitative SDS PAGE method to estimate the purity of a recombinant protein .
Successfully established a stability indicating protocol for formulation development for monoclonal antibodies.
My ability to lead a diverse team to increase the yield of Monoclonal antibody by 94% during the tech transfer and process development phase.
Successfully developed a semi quantitative SDS PAGE method to estimate the purity of a recombinant protein .
Successfully established a stability indicating protocol for formulation development for monoclonal antibodies.
Dr.Shivraj Dasari's Problem Solving Skills:
- DEveloping Documentation which meets the FDA requirements,
- Laboratory Equipments like LCMSMS, HPLC,PCR, Fermenters, Chromatography skids,
- Quality auditing and inspection skills
- Training skills
Dr.Shivraj Dasari's Problem Solving Experience:
- I have developed and validated several Molecular diagnostic tests which have been accredited by NABL - ISO 17025 and 15189 standards. I am also a lead assessor for ISO9001; ISO17025 and 15189 standards.
- I have built up a strategy for speedy registration of these Biopharmaceuticals into regulated markets by compiling their dossiers meeting the USFDA, EMA, and other International registration requirements.
I have sufccessfully designed , commissioned and qualified several Biotech companies and got them certifiede by FDA's of different countries. - One of my first product is r-DNA based Hepatitis B vaccine in the Indian market in 1997; followed by many recombinant based therapeutics both microbial and mammalian cell based products in the Indian and several regulated markets - list of products linclude Intereferon alpha, beta, GCSF, GMCSF, HGH, DArbapoeitein, Monoclonal antibodies - Enbrel, Rituxumab, Trastisuzumab, BEvatuzumab etc.
- I am a qualified cGMP,GLP and GCP specialist with more than 22 years of Industrial experience and empanelled with Deptt. of Science & Technology, Govt. Of India,. Having successfully audited about 40 different clinical pathology labs and Biotech companies. I have developed and established succcesfully tech transfer of recombinant DNA based vaccines and therapeutic proteins and Stem cells based products and have introduced into many regulated markets.