Senior Officer, Biosimilar Production
Incepta Pharmaceuticals Ltd.
Total des années d'expérience :14 years, 5 Mois
•Optimization and scale up of upstream production process (from 3.5L to 65L) of recombinant Human Insulin (using cloned Pichia Pastoris), recombinant Human Interferonα2a and recombinant Human Granulocyte colony stimulating factor (using cloned E. Coli BL21).
•Bulk production (Upstream & Downstream) of recombinant Human Interferonα2a (rh-IFNα2a) and recombinant Human Granulocyte colony stimulating factor (rh-GCSF)
•Maintaining the master cell bank and preparing working call bank (cloned E. Coli and Pichia pastoris) for the upstream production of recombinant proteins.
•Characterization of the master/working cell bank and maintaining the mammalian cell bank (e.g. NFS-60, MDBK etc.) for Bioassay
•Quality Control of the finally purified recombinant human proteins according to European Pharmacopia. i.e. QC of recombinant Human Insulin, recombinant Interferonα2a and recombinant Granulocyte colony stimulating factor.
•In-Process quality analysis of the above proteins during process development.
•Writing process/cleaning validation protocols, BMR, SOP, STP, ACS etc for new product
•Handling CCR, OOS, CAPA, Deviation, Critical incident during manufacturing
•Supervising the cleaning and environment monitoring of ‘B’ and ‘C’ grade area
•Designing new process/improving existing process and applying in trial batches
•Practicing 5S system in production floor and supervising production manpower accordingly
Specialties acquired on process and analytical equipments:
•Fermentor 100L (Bioengineering, P100), 14L (New Branswick BioFlow310)
•Cell Disruptor (Constant Systems, UK and GEA Niro Soavi, Italy)
•TFF System (Flex-Stand system, GE healthcare and Cassette system, Pall Life Sciences)
•Continuous Centrifuge (GEA Westfalia Separator, Germany)
•Batch Centrifuge - 6L (EVOLUTION RC, Thermo Scientific)
•AKTA pilot (GE healthcare)
•AKTA ready (GE healthcare)
•HPLC (Shimadzu & Dionex)
•DNA Sequencer (3500 Genetic Analyzer, Applied Biosystems, USA)
•Real Time PCR (7500 Real Time PCR Systems, Applied Biosystems, USA)
•Spectrophotometer (Shimadzu)
•ELISA reader (Thermo Scientific) & Fluorescence reader (BioTek)
•Gel Doc system (CB Scientific, USA)
Specialties acquired on laboratory analysis:
•Bradford, Lowry and BCA protein quantification
•SDS PAGE
•Isoelectric focusing
•Western blot
•Slot blot
•ELISA
•DNA detection by Picogreen method and Real-Time PCR method
•Biological assay (Interferon and Filgrastim)
•HPLC (peptide mapping, related protein, size exclusion chromatography)
•Bacterial endotoxin test (LAL test)
1. Daily analysis of water samples as:
=>Membrane filtration (for E. coli & total coliforms)
=>H2S testing (for fecal contamination)
=>Free Chlorine testing (using digital colorimeter)
2. QA/QC procedures for all water quality analysis performed.
3. Input water quality results into digital format and assist in cleaning up and interpreting data using SPSS.
4. Daily coordination with field staff to receive water samples collected from study participants.
5. Maintenance of field laboratory facility in fully functioning order at all times.
1. Sample handling: Sample(blood, stool) processing, Preservation and coordination with the field staffs.
2. Microscopic observation of different intestinal parasites.
3. Cell culture: Different microbial cell culture as well as human lymphocyte cell culture.
4. Immunological tests: ELISA, Immunofluorescence Assay etc.
5. Molecular techniques: DNA & RNA extraction by different method, Conventional PCR, Real-time & Multiplex Real-time PCR, Luminex.
6. Data management: Maintaining log book, maintaining data found from different experiments, analysis of data and interpretation of results.
Dissertations: Detection of three intestinal unicellular Parasites( Entamoeba histolytica,Giardia lamblia, Cryptosporidium spp.) by different method( Microscopy, ELISA, Real-Time PCR).
Educational Board Scholarship on the result of Higher School Certificate Examination.