Analytical Process Development

Tagen Pharmaceuticals - Quality & Analytical Department is developing and performing analytical methods to ensure a high quality of the product by determination of quantity and purity of proteins in solution and identification of analytes inter alia by high performance liquid chromatography.

    We perform:
  • LC analytical method development and validation
  • Sample analysis applying RP, SEC, IE, NP, HIC stationary phases
  • Protein peptide mapping method development
  • Impurity profiling using liquid chromatography and 2D gel electrophoresis
  • Main equipment
  • 4 HPLC systems (Waters), Applied detectors
  • UV-Vis detector
  • Multi λ Fluorescence detector
  • Evaporative Light Scattering detector
  • Ion Trap (Bruker)
  • 2D electrophoresis system (GE healthcare)
  • Western blot device (Amersham Biosciences)
  • SDS-PAGE electrophoresis device (Bio-Rad)
  • AKTAmicro chromatography system (GE healthcare)

At Tagen Pharmaceuticals, we successfully pass inspections by the concerned authorities and maintain a continuous smooth track record. Our Quality assurance (QA) department oversees production and quality systems and strives for continuous improvement to meet newest requirements. Our main goal is to ensure that biopharmaceutical products are produced for our clients according to GMP requirements and are safe to be administrated by patients.

    Main Quality Assurance services:
  • Assurance of compliance with the Good Manufacturing Practice (GMP) requirements
  • Staff training and compliance with the requirements of the quality assurance management
  • Organizing and conducting internal and external audits of the quality assurance management system
  • Organizing and controlling corrective and preventing actions of quality management
  • Management of documentation, change control, deviations, complains
  • Approval or rejection of Intermediates, active pharmaceutical ingridients (API) and drug products (DP)
  • Commercialization of advanced therapy products such as stem cells and cell-culture-based products
  • Drug launch from one market to another market
  • eCTD conversions and baseline submissions
  • Implementation of post approval changes
  • Identifying right strategies and mitigation plans for each case
  • Pre-submission interactions with HAs
  • Competitors landscape evaluation and preparation of right Regulatory strategies that suit well for product registrations ahead
  • Identification of right approach for each case/ clinical program/ marketing authorization strategies
  • Support for Orphan Drug Designation (ODD) applications
  • Product evaluation for suitability under expedited programs, and Regulatory support for submission of expedited program requests
  • Identification of Regulatory route map for submission information about process, methods and other advanced technologies (e.g. gene sequencing techniques) that are proprietary in nature
  • Evaluation of excipients against IIG data base