Company

About TBD Pharmatech

API development and manufacturing

TBD Pharmatech (formerly TBD-Biodiscovery) specialises in Active Pharmaceutical Ingredients (API), advanced intermediates, and the development and production of fine chemicals.

We are a Contract Development and Manufacturing Organisation (CDMO) with 16 years of experience in the market. We combine GMP-compliant production with strong R&D and extensive experience in the validation process—something that makes TBD the perfect partner to develop your ideas.

At TBD, we endeavour to connect personally with our customers, no matter where they are in the world. In fact, we are proud to say that 80% of our client base are returning customers.

TBD Pharmatech is located in the EU and is certified with ISO 9001.

History

2022
By now, we have 70 members on our team and we can confidently say that all our management processes are digitised. At TBD, we believe in continuous improvement and, sometimes, we want the positive changes we go through to be visible. So, TBD-Biodiscovery will be renamed TBD Pharmatech.
2020
Although 2020 was a difficult year for everybody, there were a few highlights for us as a company. For instance, we received several nominations from local and national institutions, being recognised as the Best Fast-Growing SME, Best Company in the Field of Life Sciences, and the #1 firm in the list of the TOP 10 Chemistry Companies in Estonia. Furthermore, we purchased 2 ha of land near Tartu and started designing our new development-production facilities.
2019
By this point, up to 95% of our products and services were for export, with our main markets being Germany, the Netherlands, Latvia, Israel, and South Korea. This was also the year when Dutch stakeholder SEAL Investments B.V. acquired 30% of TBD.
2018
Fast forward a few more years and TBD officially had 42 employees (a third of whom had earned a PhD). To guarantee we give the best possible service to our clients, TBD got the ISO 9001 certification. Two APIs, two research chemicals and two advanced intermediates in regular production.
2013
Seven years after its foundation, the company had grown and expanded quite a bit. By 2013, we had started working with countries outside of the EU, like Israel, Russia, Switzerland, and the US. We also began collaborating with local universities, contributing to the education and development of young chemists—TBD offers various trainee positions and also sponsors several chemistry-related competitions, such as the Estonian and Baltics Chemistry Olympiads. As for TBD’s achievements in 2013, we added an additional GMP room for cytotoxics and we patented the amrubicin semisynthetic technology in both the EU and the US.
2012
This year, TBD officially became a contract research / contract manufacturing company that focused its activities towards synthetic chemistry, downstream processing, production of commercial API, and IMP for clinical trials. TBD’s chemistry expertise was internationally recognised for the first time when our company won the HealthPort Innovation Competition.
2010
By this point, there were 13 members in our team, eight of whom had a PhD. TBD took on projects that other companies had deemed as ‘lost’—particularly those that involved complicated synthesis problems. We also began developing bioluminescence compounds.
2008
TBD got the EU’s GMP certificate for non-sterile production. We started offering our clients scale-up services, as we now had the technical capabilities to produce compounds in various quantities, ranging from just a few milligrams to several kilograms.
2007
We opened new laboratories in Tartu’s Biotechnology Park and continued to offer R&D services to our customers, like route development and small-scale synthesis. We also began collaborating with neighbouring countries, such as Finland, Sweden, and Latvia.
2006
TBD-Biodiscovery was founded as a spinoff company of the University of Tartu.

Facility

Wide range of equipment

TBD’s laboratory, production department, warehouse, and offices take up 1,250 m2 of the Tartu Biotechnology Park.

Any and all R&D activities are carried out in our synthesis and analytical chemistry laboratories. The labs are modern and give our team access to all the equipment they might need to carry out high – quality research, including:

modern preparative chromatography (flash, prep-HPLC);
model reactors for process development including high-pressure reactor;
vacuum systems for solvent evaporation and drying;
pilot scale production equipment for process scale-up;
modern chromatography equipment for analysis (HPLC-s with DAD detector, GC-s, HPLC-MS);
wide choice of other analytical methods (polarimetry, viscosimetry, automatic titrators etc.);
extensive choice of laboratory glassware;
reactors for up to 150 litres;
several class D cleanrooms.

In addition to our in – house equipment, TBD has an agreement with a higher education institution, which allows members of our staff to use specific equipment in their facilities. For example:

High-end NMR system (700 MHz)
Wide mass spectrometry capabilities ( HRMS, MS/MS )
Solid structure analyses by XRD, including single crystal XRD, MALDI mass spectroscopy for study of polymers, and ot her high molecular weight compounds

Currently, TBD is planning another expansion. We obtained 2 ha of land near Tartu, where we intend to build a new complex for development and production.

Meet the team

Andrus Tasa, PhD

Chairman of the Management Board
Andrus Tasa, PhD
PROFILE
Olga Tšubrik, PhD

Member of the Management Board
Olga Tšubrik, PhD
PROFILE

Andrus Tasa, PhD

Chairman of the Management Board
Olga Tšubrik, PhD

Member of the Management Board

Ain Uustare, PhD

Qualified Person, Head of Quality Assurance Department
Ain Uustare, PhD
PROFILE
Andi Kipper, PhD

Head of Research and Development Department
Andi Kipper, PhD
PROFILE
Ivan Ogibalov

Chief Technology Officer
Ivan Ogibalov
PROFILE
Anneli Lainela

Head of Sales Department
Anneli Lainela
PROFILE

Ain Uustare, PhD

Qualified Person, Head of Quality Assurance Department
Andi Kipper, PhD

Head of Research and Development Department
Ivan Ogibalov

Chief Technology Officer
Anneli Lainela

Head of Sales Department

Certifications

At TBD, we focus on enhancing customer satisfaction through continuous improvement.

ISO 9001

We have been certified with ISO 9001:2015 since 2018.

ISO 9001 is the most widely recognised quality management system standard worldwide. This certification guarantees that TBD conforms with all the applicable statutory and regulatory requirements to meet our customers’ needs.

The PHC Europe Quality Manageme nt System covers sales, distribution, services, and validation of our products at our site in Tartu.

Good Manufacturing Practice (GMP)

TBD is also GMP – compliant — in fact, it has been so since 2008.

GMP is what describes the standards that a pharmaceutical manufacturer must meet in their production processes.

The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards, thus enhancing the safety of pharmaceutic al products and ensuring that patients only get high quality medicines.

GMP requires that human and veterinary drugs are of consistent high quality and appropriate for their intended use. Furthermore, they need to pass the EMA’s clinical trial and meet al l the requirements for marketing authorisation.