I have worked in Biopharmaceutical industry for more than 10 years in Mexico and Cuba. Particularly my expertise relies in areas of mammalian cell culture and Quality Control focused on cell culture based-assays, proteins characterization methods, validation process, bio-similarity studies and development of analytical assays. I also have a broad experience in handing and drafting of documental support, working in a GMP/GLP environment and processing of data analysis.
BIOLOGICALS ASSAYS
• Mammalian Cell Culture and Cell bank generation and maintenance.
• Development and validation of Cell-Based Bioassay and immunoassay.
PHYSICO-CHEMIAL ANALYSIS
• Tertiary protein structure by fluorescence emission and Derivative Spectroscopy.
• Stability determination by measuring the hydrodynamic diameter of molecules (DLS)
• Quantification of product associated impurities by immunoenzymatic assays (ELISA).
• Quantification of proteins by UV analysis including the use of fluorescent markers.
• Stability and purity analysis by capillary electrophoresis (EC, cIEF)
• Characterization and stability of proteins by HPLC (CEX, CAT, peptide mapping and HILIC)
DOCUMENTAL
• Statistical and mathematical analysis of results and drafting reports (Chromeleon™, PLA 3.0, Soft MaxPro, GraphPad Prism).
• Generation of Analytical Technical Method (ATM), standard operating procedure (SOP), Result Report, Risk Analyzer under ISO 9001, BPL, GMP, ISO9001, FEUM, ICH y USP.
• Qualification and maintenance of the qualified state of laboratory equipment (IQ, OQ and PQ).
• Transfer of analytical methods from customers for their implementation into the LAMMB facility.
• Standardization and validation of non-pharmacopeias methods for submitting to COFEPRIS
(Mexican regulatory agency).
• CAPA system.
MAIN ACHIEVEMENT
• Development of methods for quantification of HCPs and Protein A by ELISA.
• Development and validation of an in vitro VEGFrh titration method HUVEC cell-based.
• Development of in vitro assay to evaluate potency of biosimilar antibody Filgrastim and PEG-Filgrastim.
• Development and validation of an in vitro assay to evaluate potency of biological PRO-169 drug.
Bioassays