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

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

Apr 05, 2023 374 likes •574 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:

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SLIDE 1

One-stop-shop for the API product development:

  • R&D competence
  • Quality guarantee
  • Efficiency in manufacture

TBD-BIODISCOVERY

R&D SERVICES AND SMALL SCALE GMP PRODUCTION IN NORTHERN EUROPE 10 years of challenges!

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SLIDE 2

COMPANY: HISTORY 2006 – 2016

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

10 years

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SLIDE 3

COMPANY: HISTORY 2006 – 2016

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)

10 years

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SLIDE 4

BUSINESS DEVELOPMENT AND MARKETS

PHARMA BIOTECH CHEMICAL and AGROCHEMICAL INDUSTRY RESEARCH INSTITUTIONS

10 years

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SLIDE 5

BUSINESS DEVELOPMENT AND MARKETS

API product development (including DMF, analytical development and impurity synthesis) Rimantadine API antiviral Analytical services: method development and validation Antazoline API antihistamine Bortezomib API multiple myeloma Zoledronic acid API Osteoporosis Amrubicin API small cell lung cancer

contract services

  • ur products

10 years

PHARMA

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SLIDE 6

BUSINESS DEVELOPMENT AND MARKETS

Complex multistep chemical synthesis Nordoxepine API PET studies Small scale contract manufacturing for clinical studies (GMP) Luciferin diagnostics Literature/patent searches

contract services

  • ur products

Peptide linkers and

  • ther fine chemicals

10 years

RESEARCH INSTITUTIONS

BIOTECH

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SLIDE 7

BUSINESS DEVELOPMENT AND MARKETS

Process development and scale-up Pheromone for Lobesia Botrana (grapevine moth) Small scale contract manufacturing Pheromone for Cydia Pomonella (apple tree moth)

contract services

  • ur products

Chloromethyl butyrate Other fine chemicals Complex multistep chemical synthesis Synthesis of standards

10 years

CHEMICAL & AGROCHEMICAL INDUSTRY

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SLIDE 8

SERVICES AND EXPERTISE

10 years

WIDE EXPERTISE IN CHEMISTRY

  • Sugars: multistep synthesis of various

derivatives

  • Pheromones and unsaturated derivatives
  • Peptide linkers
  • Metabolites of agrochemicals
  • Impurities of APIs and their synthesis
  • Fluorescent labelled molecules
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SLIDE 9

ANTICANCERS DEVELOPMENT: PAYLOADS

10 years

ADC = Antibody Drug Conjugates new generation of anticancer drugs

  • 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

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SLIDE 10

DEVELOPMENT OF NEW PRODUCTS

LUCIFERIN from TBD-Biodiscovery:

  • Simple chemistry but

extremely complicated process

  • After 6 months of work we

have established technology

  • Product of TBD-Biodiscovery has the same quality as a

product from the market leader

10 years

  • High demand in diagnostics and cancer research
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SLIDE 11

ANALYTICS

  • 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

10 years

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SLIDE 12

PROJECT MANAGEMENT AND CUSTOMER FOCUS

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

10 years

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SLIDE 13

PARTNERS AND CUSTOMERS WORLDWIDE

Germany Finland Austria Estonia Spain Ireland Sweden United Kingdom Holland Latvia France Italy USA Israel Switzerland Russia Denmark

10 years

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SLIDE 14

 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

PARTNERS AND CUSTOMERS

10 years

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SLIDE 15

BUSINESS STRENGTHS OF THE COMPANY

  • 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

10 years

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SLIDE 16
  • 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

BUSINESS STRENGTHS OF THE COMPANY

10 years

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SLIDE 17

TECHNICAL STRENGTHS OF THE COMPANY

  • 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

10 years

THE TEAM

10 years

Thank You for choosing us!

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SLIDE 18

LUCIFERIN from TBD-Biodiscovery:

  • After 6 months of work we have established technology
  • Product of TBD-Biodiscovery has the same quality as a

product from the market leader

DEVELOPMENT OF NEW PRODUCTS

10 years

THE TEAM

10 years

TBD-BIODISCOVERY Tiigi 61b, 50410 Tartu, Estonia Tel: +372 747 7501 Fax: +372 736 6099 www.biodiscovery.eu info@biodiscovery.eu sales@biodiscovery.eu CONTACT DETAILS