KIEV, Oekraïne & TARTU, Estland–(BUSINESS WIRE)–
Samenwerking combineert expertise op het gebied van nieuwe chemische samenstellingen met GMP vervaardiging in geneesmiddelenontdekking
Enamine Ltd., een organisatie voor chemisch onderzoek en producent van nieuwe bouwstenen en screeningbibliotheken, en TBD Biodiscovery, een premium GMP-fabrikant van chemicaliën met inbegrip van chemische actieve farmaceutische ingrediënten (API’s), hebben vandaag aangekondigd een samenwerkingsovereenkomst te zijn aangegaan. Het partnerschap heeft tot doel de overgang van chemische synthese van nieuwe tussenproducten van laboratorium- naar bulkschaal volgens GMP-standaarden te beheren, waarbij gebruik wordt gemaakt van Enamins knowhow en expertise op het gebied van procesontwikkeling. Dit zal onderzoekers helpen te voldoen aan de productiehaalbaarheidscriteria die vereist zijn voor de selectie van kandidaat-geneesmiddelen, waardoor een snelle en kosteneffectieve schaalaanvoer van nieuwe samenstellingen mogelijk wordt.
Enamine and TBD Biodiscovery Collaborate to Provide GMP-Based Services
KIEV, Ukraine & TARTU, Estonia–(BUSINESS WIRE)–
Collaboration Combines Expertise in Novel Chemical Compound Synthesis with GMP Manufacture in Drug Discovery
Enamine Ltd., a chemical research organization and producer of novel building blocks and screening libraries, and TBD Biodiscovery, a premium GMP manufacturer of fine chemicals including chemical active pharmaceutical ingredients (APIs), today announced they have entered into a collaboration agreement. The partnership aims to manage the transition of chemical synthesis of novel intermediates from laboratory to bulk scale under GMP standards utilizing Enamine’s know-how and process development expertise. This will help researchers meet the manufacturing feasibility criteria required for drug candidate selection, providing a rapid and cost effective scaled supply of new compounds.
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Enamine’s catalogue of building blocks is the largest in the world and has been widely used by pharmaceutical companies for more than 15 years to develop lead compounds and drug candidates. With syntheses of these compounds first realized by Enamine, the company holds specialist knowledge that can be critical to successful scale-up. In the announced collaboration Enamine will optimize synthesis processes while TBD Biodiscovery will use the developed protocols to manufacture requested products to GMP standard.
Dr. Vladimir Ivanov, Chief of Sales and Marketing at Enamine, commented: “We recognize that the building blocks we synthesize are being incorporated into the development of new drugs. We are confident that by working in partnership with TBD Biodiscovery with their extensive experience in providing synthesis services under GMP, we can further extend the support we provide and help streamline the manufacturing process.”
Dr. Andrus Tasa, Chairman of the Management Board of TBD Biodiscovery, adds: “I have been very impressed by the creativity of Enamine’s chemists in designing new chemical synthesis. We are happy to have Enamine’s support in optimizing the chemical processes used by us for GMP manufacture.”
About Enamine Ltd. www.enamine.net
Established in Kyiv, Ukraine in 1991, Enamine is a chemical company producing building blocks and screening libraries of world reputation. The major asset of the company is the world’s largest collection of building blocks: 150,000 in stock with 2,000 additions synthesized each month. These research functionalized compounds provide a significant competitive advantage to the company in supplying custom compound libraries particularly in the frame of medicinal chemistry collaborations or compound collection enhancement programs. Custom synthesis and kilogram scale up based both on fee-for-service and FTE models represent another area of business activities provided by Enamine, which are growing significantly in recent years.
About TBD Biodiscovery www.biodiscovery.eu
TBD Biodiscovery is a private company providing contract manufacturing and R&D services for biotech and pharma industry. The company has European GMP certification and offers top quality in the production of chemical APIs (both commercial and clinical batches), pre-formulations for clinical studies and excipients – everything in compliance with the strictest GMP guidelines. Since the beginning in 2006, TBD Biodiscovery is renowned for its strong experience in synthesis route design/scouting, complex multistep synthesis and upscale process development.
TBD Biodiscovery is based in Tartu, Estonia and operates worldwide; its clients’ portfolio includes customers from EU, Switzerland, US, Israel, Russia and South Korea.
Michael Bossert, +38 044 537 32 18
Head of Strategic Alliances
Dr. Olga Tšubrik, +372 747 25 01
Head of Business Development
Sarah Jeffery, +44 7771 730919