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We are a centre of excellence in bile acid chemistry and its application in health and pharmaceutical products

Our distinctive strength is a profound knowledge of bile acids synthesis and chemical behaviour including their extraction and purification. Our synthetic approach to bile acids embraces both organic and enzymatic chemistry.

We have a strong focus in designing and developing sustainable processes both for generic and new products.

Our innovative approach has resulted in ICE Pharma being granted a number of international patents.

Centres

We have 5 R&D centres, spread across Italy, United Kingdom, India and New Zealand

All of which allow the Company continuous growth, through the constant development in bile derivatives field as well as in innovative research and development in plant-based bile acid chemistry along with consolidated expertise in carbohydrates.

Our R&D expertise also includes the formulation of liquid and solid final dosage, with both API and Pharma R&D services covering scale up, technology transfer, analytical methods development/validation and support in registrations.

ROUTE SCOUTING AND PROCESS DEVELOPMENT

Our R&D teams are skilled at identifying new routes of synthesis and developing industrial processes

Our laboratories are equipped to take processes from gram to kilogram scale supporting route scouting and process optimisation.

Our skilled team is able to perform a wide spectrum of chemical reactions, including hydrogenations, organometallic reactions, coupling, oxidations, and reductions with metals and hydrides. Their main activity is the identification of new routes of synthesis for bile acid derivatives starting from both animal and plant based raw materials. Our laboratories are equipped with automated parallel reactors to accelerate development.

Supporting our synthesis projects are knowlegable and well equipped analytical teams. Most chemical analysis can be performed in-house but we also have relationships with industrial and academic partners to provide additional specialist analytical support.

RESEARCH FOR NEW CHEMICAL ENTITIES

Our bile acids (BA) branch’s distinctive element is in early-stage research

Recent medical research has revealed the role of bile acids as metabolic regulators and uncovered their potential to treat a variety of diseases.

ICE Pharma is conducting innovative research to identify and syntheses novel bile acids with potential biological activity.

This has led to the creation of a library of approximately 500 modified bile acid structures for screening as potential candidates for unmet medical needs in areas such as hepatic and motoneuron disease. Many of these molecules are novel and are covered by composition of matter patents. ICE Pharma is bringing forward a number of these compounds as lead candidates for clinical trials.

These projects are supported by collaborations with top worldwide universities and academics using cutting-edge technologies.

Expertise

Our core capabilities include

  • Impurities identification

    Deep expertise in impurities isolation, structure identification, retrosynthesis.

  • Analytical R&D

    Technologies available in house; HPLC (UV, RI, CAD, ELSD detector), GC, GC HS, GC-MS, HPLC-MS, NMR plus external collaborations for any other type of analysis including synchrotron.

  • Kilolab

    In house glassware equipment both for non-GMP and GMP Kilo scale production to scale up and support customers’ initial needs.

  • Technology transfer

    Consolidated experience in transfer production up to several hundred Kg batch size both in house and via external CMOs.

  • Process optimization and industrialization

    Long experience in managing all product lifecycle to maintain process competitiveness.

  • IP support

    Providing full coverage to the proprietary ROS.

  • Stability studies

    Including ICH condition and different climate zones.

  • Formulation and development of liquid and solid dosage for oral use

    With a covered area of 32.000 square meters, our plant in Ivrea is specialized in the production of oral liquid and solid forms, with a production capacity over 30 million of packs per year.

  • Novel bile acids

    The discovery and synthesis of new chemical entities for the development of new drugs.