Alier Guedes Yero

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.

• BILOGICALS ASSAYS
  • Cell culture, preparation, and characterization of Cell Banks.
  • In vitro virus culture and preparation of viral banks stocks.
  • In vitro assays for detection and quantification of viruses from IPC (In Process Control) samples andcell banks.
  DOCUMENTAL
  • Sanitary Registry of different proprietary drugs and maintaining of their regulatory standard.
  • Documental management including SOPs (Standard Operating Procedures), validation protocols, andreports of analytical results.
  • Validation of contaminant agents removal through drugs manufacturing processes.
  MAIN ACHIEVMENTS:
  • Validation of virus removal in 1B8 Mab purification process.
  • Development of the Hemagglutination assay for the Determination of Adventitious viruses in Mabharvest samples.
  • Validation of an in vitro assay for Determination of Adventitious Viruses.
  • Development of a test to assess the Median Tissue Culture Infectious Dose (TCID50) of endogenousretrovirus in PG-4 Cell Line.
  • Validation of an assay for the determination of retroviruses by XC plate method.
  • Participation in the drafting of CTD (Common Technical Document) in order to submit theNimotuzumab for its registration by EMEA.
  • Sanitary Registry of different proprietary drugs and maintaining of their regulatory standard.