Irina Kostareva Email & Phone Number

 Responsible for the protein purification process development, optimization, scale-up and transfer to the manufacturing with necessary documentation.  Developed polishing steps for the quality improvement of final product  Participation in GMP production, process and viral clearance validation.

 Responsible for marketing and sales of Atoll chromatography products in the US Developed applications and provide technical service for Atoll products with emphasis on protein drug discovery, protein analysis and upstream and downstream process development Expanded Atoll presence at 21 new accounts with greater than 500% revenue increase Conducted.

Parsippany, New Jersey, US

Director, Process Development Department  Responsible for monoclonal antibody (MAb) purification process development, scale-up, analysis, formulation, stability study, transfer to CMO and CMC documentation generation Developed and scaled-up MAb modification and conjugation processes  Devised scalable MAb conjugate purification process  Developed.

New York, US

 Responsible for autimated clinical diagnostic assay modification, transfer and validation  Introduced various methods onto new clinical analyzers with proper validation and documentation  Optimized reagents for the automated pancreatic lipase diagnostic assay which resulted in reproducible assay performance

 Responsible for analytical QC method development for peptide-protein complexes, protein purification and conjugation process development  Developed and characterized therapeutic vaccine formulation Developed and validated HPLC-based QC methods including product release tests Developed HPLC methods to monitor peptide, protein and oligonucleotide.

 Responsible for ELISA development and optimization based on the development, validation and transfer of purification processes for protein conjugates Successfully designed, scaled-up and transferred conjugation processes for proteins and purification processes for conjugates, MAbs and associated fragments used in HTLV, HIV and HCV ELISA.  Developed.

Morris Plains, New Jersey, US

 Developed and improved purification processes for MAbs and their fragments  Scaled up MAbs and their fragments purification processes  Liaised with Regulatory Affairs to develop critical validation data for regulatory filings Generated technical documentation, sections in regulatory filing documents for BLA

 Isolated and purified recombinant HIV-1 p24 and gp160, Interleukins-1 alpha and beta, human erythrocyte acetylcholinesterase, monoclonal and polyclonal antibodies Supervised manufacturing of recombinant Interleukin-1 beta from fermentation to purified end product Purified influenza, parainfluenza, RS viruses Developed immunoenzyme diagnostic tests and.