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Consultancy

Kantisto covers all phases of drug development, from discovery and early phase up to late phase development, marketed product support and line extensions. Kantisto can support you with practical technical issues, Quality by Design and also with documentation for regulatory approval such as IMPD/IND and MAA/NDA. There is a long experience with quality systems such as GLP and GMP. A focus on knowledge transfer and implementation means that Kantisto prefers to work not just for you, but with you on-site, in close cooperation and collaboration, with a pragmatic scientific and personal approach.

Support activities

  • Scientific and managerial coaching
  • Technical coaching, training and workshops
  • Quality by Design QbD
  • Analytical QbD and scientific approaches of Analytical Procedure Development and the development process toward ICH Q14
  • Method life cycle management and maintenance
  • Reviewing and writing Regulatory CMC / Module 3 documentation
  • Implementation trajectories of instrument and technique
  • Good working practices
  • Method scouting
  • Method and application development, validation and transfer
  • Troubleshooting and application improvement
  • Pragmatic quality systems, GLP, GMP

Examples of projects

  • Long-term projects within biotech companies and a clinical lab providing coaching and scientific expertise
  • Supervision and coaching of young scientist and managers
  • Interim teaching at BSc, MSc and PhD levels
  • Horizon2020 IMI2 Joint Undertaking project iConsensus, a project to develop an integrated control and sensing platform for in-process control of a biopharmaceutical cultivation process high-throughput development and production
  • (On-site) Trainings and courses in the areas of:
    • Pharmaceutical analysis
    • Method development
    • Method validation and transfer
    • Fundamental analytical chemistry
    • Chromatography data systems
    • Quality in the analytical work stream
    • Analytical Quality by Design
    • Capillary electrophoresis
    • NMR
  • European Union StartUJ teaching project CapiLab at the Jagiellonian University of Krakow, Poland 2017 - 2019 in the areas of pharmaceutical analysis and capillary electrophoresis
  • Scientific advice on analytical and quality issues, among which:
    • Literature search and report for challenging drug development topic
    • Alternative physical-chemical characterization and dissolution
    • Quality by Design
    • Advice and demonstration on capillary electrophoresis as complementary technique or as replacement for slab gel electrophoresis
    • Advanced course on chemical analysis
    • Method validation
  • Scientific report writing or review for (biotech) pharmaceuticals
  • Review of regulatory CMC documents, including specifications
  • Method scouting and method development on pharmaceuticals, biotech products incl. vaccines, proteins, chemicals and clinical applications, both practical work and well as in an advisory or coaching role
  • Characterization of active pharmaceutical ingredient with dissolution techniques
  • A strategy for chiral separation method development with CE
  • Monitoring cations and anions by CE with indirect UV detection or contactless conductivity detection
  • Capillary techniques within biopharmaceutical analysis
    • Capillary Iso-Electric Focusing
    • Transfer from SDS-PAGE to CE-SDS methods
    • CZE method scouting
    • Validation and transfer
  • Transfer from HPLC to UHPLC methods
  • CE-MS
  • Troubleshooting, e.g. GMP batch release issue CMO
  • GMP tech transfer, support of QC labs on equipment changes
  • Developing e-learning tools for analytical scientists and technicians
  • Organization of symposia and discussion fora