TBD-Biodiscovery: Contract Development & Manufacturing Organization
TBD-Biodiscovery Ltd is an Estonian company specializing in developing, manufacturing, and selling active pharmaceutical ingredients. With core expertise in organic chemistry and a focus on niche generics and innovative NCEs, TBD-Biodiscovery offers services such as total synthesis of natural products, contract manufacturing of APIs, and regulatory compliance support. The company is GMP-certified for manufacturing clinical and commercial batches, as well as formulations for clinical studies.
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Presentation Transcript
TBD-BIODISCOVERY Ltd CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION IN THE BALTIC STATES 2022
TBD-Biodiscovery is an innovative Estonian company, founded in 2006 by private capital and contributing to modern healthcare and biotech industry. In Netherlands joined the company (30% shares) 2019 investors from TBD TBD- -Biodiscovery Biodiscovery TODAY TODAY Develops, manufactures and sells active pharmaceutical ingredients provide our clients with the full spectra of chemistry-related services production/registration of API. (APIs). We necessary for We are focused on low volume/high added value products, which means that we can work with both niche generics and innovative NCEs.
TBD TBD- -Biodiscovery Biodiscovery SERVICES SERVICES
Total synthesis (20-30 steps) of natural products Complex carbohydrate chemistry Polycyclic compounds Organometallics including Grignard CORE Expertise in organic organic chemistry chemistry Impurities of APIs Cytotoxics (HPAPI) Metal-catalyzed and transfer hydrogenation Peptide couplings Bioluminescent dyes Metal-mediated reactions
Contract manufacturing Focused on active pharmaceutical ingredients (API) custom manufacturing TBD TBD- -Biodiscovery Biodiscovery SERVICES SERVICES Synthesis of high-potency APIs (HPAPI), cytotoxic and non-cytotoxic Preparation of excipients Advanced intermediates
Regulatory and compliance Full ASMF compilation and support TBD TBD- -Biodiscovery Biodiscovery SERVICES SERVICES GMP compliance certificate since 2008 In 2018 the management system of the company has been certified according to the standard ISO 9001:2015
GMP GMP- -CERTIFIED MANUFACTURING CERTIFIED MANUFACTURING CLINICAL BATCHES (IMP) COMMERCIAL BATCHES PRE- EXCIPIENTS FORMULATIONS FOR CLINICAL STUDIES
In 2020: new cGMP area equipped with 100 L Glass-Lined reactor, distillation skid and thermostate was added cGMP compliant Cleanroom class D equipped for filtering/drying/ packaging Six cGMP qualified multipurpose production areas in total HPAPI GMP production in small scale in BioSafety cabinet Reactors up to 150 L with total capacity of ca 1000 L Rotary evaporators A API PI 3 L- 50 L MANUFACTURIN MANUFACTURING G Special equipment: hydrogenators of Operation scale: Distillation equipment 100 mg - 20 kg/batch 5 L/50 bar and 20 L/20 bar
PLANS FOR 20 PLANS FOR 2023 23- -202 2024 4 New API facility/building: increase capacity to 100-250 kg per batch with reactors of 2500 L Project engineering for the new building ongoing Construction of the building starting 2022 (plot of area near Tartu was purchased in 2019)
TBD-Biodiscovery produces Ultrahigh grade D-Luciferin and D-Luciferin K salt. Both products can be supplied in bulk quantities (kilos). Fine chemicals Fine chemicals development and production and production TBD-Biodiscovery is one of very few companies in the world which has know-how for manufacturing WHITE Luciferin and WHITE Luciferin K-Salt.
SKILLS AND EXPERIENCE: Organic chemistry Chemical technology Analytical chemistry Bioorganic chemistry QC/QA Staff of 72 persons (Number of PhDs 19) EU GMP and ASMF CORE STRENGHTS CORE STRENGHTS PROJECT MANAGEMENT Key Account Managers and Project Managers Regular reporting to the customer Management according to ISO 9001
Curados B.V. (Netherlands) Stanford University (US) Joseph Fourier University (France) CABB (Finland, Germany, Switzerland) TUBE Pharmaceuticals (Austria) TEVA (Israel) Adama Makhteshim (Israel) A. E. Tiefenbacher (Germany) CFM Oskar Tropitzsch (Germany) Double Bond Pharm (Sweden) Grindeks (Latvia) Dechra (UK) Kemira (Finland) etc We are open to different models of collaboration! Reliable partner Reliable partner from early from early development up development up to commercial to commercial manufacturing manufacturing
Tiigi 61b, 50410 Tartu, Estonia +372 747 2501 Contact Contact us: www.biodiscovery.eu sales@biodiscovery.eu
