Seize growth opportunities

      Our Prorities


    RESEARCH AND DEVELOPMENT

    Development and commercialization of new, attractive APIs is the priority of the POLPHARMA API R&D Department. The key to our success is the combination of experience and expertise of our own research team as well as effective co-operation with scientific institutions. 

    57 highly qualified Professionals, including 16 with PhD degrees, are employed in API R&D Department:

     
    5 R&D Management
    (including Planning)
    3 Project
    Management
    20 Analytical
    Development
    Laboratory
    13 New Process
    Development
    4 Process
    Improvement
    Laboratory
    12 Regulatory Service
    Dept. & Prod. Doc.
     

     


    Borderless r&d

    R&D development approaches

    • Project development strategy for early launch in FTO and launch in IP regulated territory
    • Identification and differentiation in API in terms of CQA
    • New Therapeutic Categories/Technologies

    Acquisition of Technology and Technological Solutions

    • to bridge the gap for Product launch

    Strategic partnerships

    • integrated network with external competency centers
    • Our strategy is based on partnerships which form and strengthen technology platforms for long-term growth, creating value for our customers.
    • Partnerships with other companies and development houses offer new technologies, identify the best projects and drive costs down with environmental sustainability.


      ADDED VALUE TO BUSINESS

     

    • First generic launch - Technology development strategy for IP-regulated markets
    • Technology development strategy for early launch in non-IP and non-regulated markets
    • API differentiation – Solutions for new or mature API for line extension as well as generic launch in line with innovator (solid state chemistry, pro-drug, chiral compounds, adducts) in FDF development
    • New therapeutic category/technologies – Peptides and Oncology




      Competitive Competences

     

    • Well-educated and experienced research staff – Process and Analytical
    • Compliance with GLP requirements in line with FDA and ICH guidelines
    • Wide network of Research and Development cooperating institutions (Universities, Institutes, CROs, Private Development Labs)
    • Application of Quality by Design and Chemometrics in process development
    • Project Management and Resources Planning System
    • Wide spectrum of processes and technologies in house and with Partners
    • cGMP Pilot-Plant
    • Experience in lab development, scale-up transfers and process improvements

      Spectrum of Chemistry Process Capabilities (in-house and at partners)

    • Regular Organic Chemistry processes (coupling, condensations, oxidations, reductions, solvolysis etc.)
    • Chiral separations (diastereoisomeric crystalizations)
    • Stereoselective Synthesis
    • Regioselective Synthesis
    • Grignard reactions in large scale
    • Carbohydrate Chemistry (glycosylations, functional groups transformations)
    • Aminoacids and Peptide Chemistry (solution and solid-phase synthesis)
    • Phosphorous Chemistry (eg. Bisphosphonates)
    • Polymorphism and solid state chemistry
    • Catalysis (phase transfer catalysis, heterogenous and homogenous)
    • Catalytic Hydrogenation at large scale
    • Sodium amide at large scale