API

Synthesis of Drug Substance

Arcinova provides full synthesis of drug substance and support services to big pharma, specialty pharma and biotechnology companies as an unique, integrated provider of chemistry, biology and process technology.

We run a one stop development and kilo scale manufacturing facility, ensuring a service provision of manufacturing processes which can be scaled from grams to multi kilos. We are strong in route selection, process development and impurity tracking / control through our onsite process chemistry, radiolabelled synthesis, analytical and drug development teams. We innovatively develop bespoke solutions for technically difficult challenges and give our customers a better deal in terms of speed, cost and quality. 

 

API Development Case Study 

 

Arcinova have over 30 years’ experience in the synthesis of labelled pharmaceutical and non-pharmaceutical molecules critical to successfully achieving key development milestones.  Our highly trained chemists have extensive chemical and radiochemical knowledge, providing consultancy and advice on the most suitable labelling positions for a variety of molecular entities.

Whether you need isotopically labelled compounds for the conduct of non-clinical or clinical metabolism studies, the quantification of materials in biological matrices or to determine environmental fate and effect, our expertise provides the necessary labelled materials tailored to support your studies.

Our custom labelling synthesis services benefit from synergies with a range of other services. API Development allows for provision of key intermediates for labelling work. With formulation development, IMP manufacture and dossier writing expertise on site, there is great flexibility for integrating the provision of labelled materials with your development programme.

Custom Process Research, Development and Scale-up

Arcinova continue to invest heavily in people, technology and facilities and can offer 1-20kg scale GMP API development and manufacturing capability.

 

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Isotopic Labelling Services

Arcinova offer both radiolabelling (including 14C) and stable isotopic labelling services. 

 

 

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