GMP Services, Heterocyclic Chemistry, Stress Stability Studies

Ubichem

Ubichem Plc was founded in 1978 in the UK, and Ubichem Research, which provides our Pharma Services, created in Budapest in 1996 to take advantage of the tradition of pharmaceutical chemistry in Hungary. We now offer a comprehensive range of chemistry services (on lab to pilot plant scale) to support pharmaceutical development and meet the drug substance requirements of our pharmaceutical and biotech partners around the world.more

These include cGMP API and intermediate manufacture for preclinical and clinical trials, process research and development, analytical method development and validation, and radiolabelling. Our experienced team minimise the risks associated with scaling up medicinal chemistry routes, and have particular expertise in heterocyclic and organometallic chemistry.

cGMP Manufacturing Services

To meet the needs of our customers’ development programmes Ubichem provide cGMP manufacturing services, supplying API and intermediates on lab to pilot plant scale. We are approved by the regulatory authorities for the manufacture of API from preclinical through to commercial supply. Our experienced process research and development team address route selection and safety evaluation, availability and cost of key raw materials, process optimisation and scale-up to enable rapid supply of materials to tight project deadlines.

cGMP Manufacturing cGMP Manufacturing

Manufacture takes place in facilities which include a class 100,000 API lab, Kilo Lab, and a pilot plant with vessels up to 1,600 litre, including a 1,000 litre Hastelloy C reactor capable of operating down to -80°C.Such work is supported by a fully qualified, well equipped analytical laboratory and comprehensive SOPs.

Heterocyclic Chemistry

Heterocyclic ChemistryUbichem have particular expertise in heterocyclic chemistry and our experienced team of chemists have made many nitrogen-containing heterocycles including quinolines, isoquinolines and pyridines, along with more elaborate bicyclic and polyheterocyclic ring systems such as thienopyridines, thienopyrimidines, azaindoles and benzofuropyrimidines.

Besides working with partners on projects under CDA in this area we also offer a broad range of novel building blocks for use in medicinal chemistry programmes through our Discovery Chemicals Catalogue. Compounds in our catalogue are typically available in gram scale from stock, with larger quantities made on request.

Stress Stability Studies

Stress Stability StudiesHaving manufactured your drug substance, or intermediate, Ubichem are experienced in undertaking stress tests, along with accelerated and long term studies, on the materials. The purpose of our stress stability studies is to promote degradation of the API under different forced conditions, to determine degradation products and mechanisms, look at photostability and moisture sensitivity, examine packaging material compatibility, and demonstrate the suitability of the chosen analytical method to assess purity of the product.

Long term and accelerated stability studies are conducted to determine whether the drug substance changes with time under the influence of environmental conditions such as temperature and relative humidity. Data obtained will help to determine shelf-life and storage conditions of the pharmaceutical products, and will form an important part of regulatory authority submissions.

Synthesis of Impurities

Synthesis of ImpuritiesIn support of development programmes and regulatory submissions Ubichem offer the synthesis of impurities and reference standards. Having identified impurities generated during production using appropriate analytical tools our experienced team design routes and undertake the synthesis of complex chemical compounds.

We offer reliably high quality products, validating all materials with the latest analytical methods, and keeping development projects on course.

Radiochemical Synthesis

Our radiochemical synthesis team provide support for development programmes.

Radiochemical SynthesisThe group has much experience in the synthesis of radiolabelled (14C and3H) and stable labelled (13C,2H, 15N) compounds for use in pharmacokinetic, metabolic and other biological studies.

Syntheses of such compounds are designed to incorporate labels in specific positions, and are supported by a comprehensive analytical package. We also offer retesting and re-purification services, along with on-site storage of labelled materials. Compounds can be shipped around the world, with on-time delivery services offered, if required.less

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Ubichem
Illatos
1097 IX, Ker
Hungary

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