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TBD-BIODISCOVERY 10 years of challenges! R&D SERVICES AND - PowerPoint PPT Presentation

Apr 05, 2023 •374 likes •570 views

TBD-BIODISCOVERY 10 years of challenges! R&D SERVICES AND SMALL SCALE GMP PRODUCTION One-stop-shop for the API IN NORTHERN EUROPE product development: R&D competence Quality guarantee Efficiency in manufacture 10 COMPANY:

  1. TBD-BIODISCOVERY 10 years of challenges! R&D SERVICES AND SMALL SCALE GMP PRODUCTION One-stop-shop for the API IN NORTHERN EUROPE product development: • R&D competence • Quality guarantee • Efficiency in manufacture

  2. 10 COMPANY: HISTORY 2006 – 2016 years 2006 TBD-Biodiscovery is established by entrepreneurs and scientists to offer services for pharma and biotech 2008 GMP certificate 2010 Class D cleanroom and first manufacturing unit 2011 First batches of Active Pharmaceutical Ingredient produced

  3. COMPANY: HISTORY 2006 – 2016 10 years 2012 New premises for research and manufacturing (> 250 m2) 2013 Participant in several European projects Amrubicin technology is patented in EU 2014 Additional separate GMP-facility for anticancers Extended GMP license for pre-formulations 2015 Development of new payloads and linkers for ADC Routine manufacturing of Ultrahigh grade D-Luciferin TBD-Biodiscovery is a partner in Estonian Competence Centre on Health Technologies (CCHT)

  4. BUSINESS DEVELOPMENT AND MARKETS 10 years PHARMA BIOTECH CHEMICAL and AGROCHEMICAL INDUSTRY RESEARCH INSTITUTIONS

  5. 10 BUSINESS DEVELOPMENT AND MARKETS years our products contract services Rimantadine API API product antiviral development (including DMF, Antazoline API analytical development antihistamine and impurity synthesis) PHARMA Zoledronic acid API Analytical services: Osteoporosis method development and validation Amrubicin API Bortezomib API small cell lung cancer multiple myeloma

  6. BUSINESS DEVELOPMENT AND MARKETS 10 years contract services our products Complex multistep Nordoxepine API chemical synthesis PET studies BIOTECH Literature/patent Luciferin searches diagnostics RESEARCH Small scale contract INSTITUTIONS Peptide linkers and manufacturing for other fine chemicals clinical studies (GMP)

  7. 10 BUSINESS DEVELOPMENT AND MARKETS years our products contract services Pheromone for Lobesia Complex multistep Botrana (grapevine chemical synthesis moth) CHEMICAL Synthesis of standards Pheromone for Cydia Pomonella (apple tree & AGROCHEMICAL moth) Process development INDUSTRY and scale-up Chloromethyl butyrate Small scale contract manufacturing Other fine chemicals

  8. 10 SERVICES AND EXPERTISE years • Sugars : multistep synthesis of various derivatives • Pheromones and unsaturated derivatives • Peptide linkers • Metabolites of agrochemicals • Impurities of APIs and their synthesis • Fluorescent labelled molecules WIDE EXPERTISE IN CHEMISTRY

  9. 10 ANTICANCERS DEVELOPMENT: PAYLOADS years • Oligopeptidomimetics: Monomethyl auristatins (MMAE, MMAF) Synthesis Synthesis of their conjugates with different spacers and linkers • Oligopeptidomimetics: Tubulysines. 20-30 step synthesis Construction and coupling of the building blocks Separation of diastereomers, development of purification methods • Anthracyclines Total synthesis with the step-by-step polycycle and side-chain construction and following modifications Modification of anthracyclines accessible by fermentation Amrubicin, Nemorubicin, metabolites etc etc ADC = Antibody Drug Conjugates new generation of anticancer drugs

  10. 10 DEVELOPMENT OF NEW PRODUCTS years LUCIFERIN from TBD-Biodiscovery: • Simple chemistry but extremely complicated process • After 6 months of work we have established technology • High demand in diagnostics and cancer research • Product of TBD-Biodiscovery has the same quality as a product from the market leader

  11. ANALYTICS 10 years • Analytics in-house : HPLC-s prep HPLC-s GC GC/MS UV-VIS • LC/MS (service in the same building) • Analytics outsourced to University of Tartu:  NMR (400 MHz, 700 MHz)  MS, HRMS • Analytics outsourced to other companies:  heavy metal analysis by AAS, elemental analysis • Stability studies are performed by partner companies  Technical agreements (if not GMP)  Technical agreements with Audit from our QA

  12. PROJECT MANAGEMENT AND CUSTOMER FOCUS 10 years Project Management • Detailed calculation of the human ressources usage • Time-schedule of a project is planned with hour accuracy • Permanent internal controlling of using the ressources • Permanent internal reporting to the Management Board • Quality Control throughout the whole process! Communication with the customer • Weekly reporting and regular phone conferences • A Project Manager and a Key Account Manager are assigned to every Project • Key Account Managers and Project Managers are easily contacted by e-mail, phone or Skype

  13. PARTNERS AND CUSTOMERS WORLDWIDE 10 years Italy Austria Latvia Denmark Russia Estonia Spain Finland Sweden France Switzerland Germany United Kingdom Holland USA Ireland Israel

  14. PARTNERS AND CUSTOMERS 10 years  CFM Oskar Tropitzsch (Germany)  CABB Chemicals (Finland and Switzerland branch)  Perrigo API (Israel and UK branch)  Intrace Medical (Switzerland)  R&D Biopharmaceuticals (Germany)  TUBE Pharmaceuticals (Austria)  Grindeks (Latvia)  Biovitrum (Sweden)  Stanford University (US)  Galmed Pharmaceuticals Ltd. (Israel)  Joseph Fourier University (France)  ... etc etc

  15. 10 BUSINESS STRENGTHS OF THE COMPANY years • Existing loyal customers • Product portfolio with sales hits such as D-Luciferin • Fast decision making process • Competitive cost level • Strong customer focus and open communication skills • Motivated and competent staff

  16. 10 BUSINESS STRENGTHS OF THE COMPANY years • Project management • Quality System in compliance with EU Good Manufacturing Practice and audited by customers and Estonian Agency of Medicines. • Experience in GMP manufacture and documentation • Wide range of experience in synthetic chemistry (including multistep synthesis up to kg scale, cytotoxics and anticancers) and high variability of services • Existing infrastructure for synthetic chemistry

  17. THE TEAM 10 TECHNICAL STRENGTHS OF THE COMPANY Thank You for choosing us! 10 years years • Project management • Quality System in compliance with EU Good Manufacturing Practice and audited by customers and Estonian Agency of Medicines. • Experience in GMP manufacture and documentation • Wide range of experience in synthetic chemistry (including multistep synthesis up to kg scale, cytotoxics and anticancers) and high variability of services • Existing infrastructure for synthetic chemistry

  18. CONTACT DETAILS THE TEAM 10 DEVELOPMENT OF NEW PRODUCTS 10 years years LUCIFERIN from TBD-Biodiscovery: TBD-BIODISCOVERY • After 6 months of work we have established technology Tiigi 61b, 50410 Tartu, Estonia • Product of TBD-Biodiscovery has the same quality as a product from the market leader Tel: +372 747 7501 Fax: +372 736 6099 www.biodiscovery.eu info@biodiscovery.eu sales@biodiscovery.eu

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