Expertise

Our research team is composed of both physicists and chemists with a wide scientific background

Our research team is composed of both physicists and chemists with a wide scientific background

Holodiag specializes in pharmaceutical solid state and crystallization. Our research team is composed of both physicists and chemists with a wide scientific background.

We have particular expertise in polymorphism, enantiomer separation, scalable processes, high toxicity samples and regulatory support.

Our laboratories are fully equipped with specialized physico-chemical analytical equipment.

This mixture of technical know-how and industry experience constitute the key to successfull achievement of the projects are customers entrust to us.

 

Polymorphism

The different pharmaceutical states (polymorph, solvates and hydrates, salts, co-crystals, amorphous solid dispersions) have major impacts on processes, including yield, purity, solubility, drying, intellectual property, etc.

Holodiag has strong expertise in solid state characterization, establishing stability hierarchy and developing selective crystallization processes. Rationalization of the stability hierarchy of solid forms allows to develop secured processes without any interfering crystallization.

Thermodynamics & phase diagrams

Holodiag drives crystallization studies by rationalization of the physical phenomena. This is done by means of thermodynamics, heterogeneous equilibria and phase diagrams.

Rationalization allows to build optimized and reproductible crystallization processes and to drive cost and time efficient studies. We can therefore provide consistent, relevant and reliable answers.

Enantiomer separation

Holodiag has deep expertise in enantiomer separation by crystallization. Selective crystallization of diastereomers or preferential crystallization of enantiomers are efficient techniques to obtain pure enantiomers in a solid state.

We manage enantiomer separation from resolving agent screening to pure kilolab batches. Our specific know-how allows process optimization to achieve the highest yields and optical purities.

Scalable processes

Holodiag develops industrializable and scalable crystallization processes at laboratory scale (glassware reactors).

We support our customers with the control of key process parameters, including cooling rate, acceptable solvants, filterability and robustness.

High toxicity samples

Holodiag has deep expertise manipulating and analyzing high toxicity samples, including Highly Potent APIs (HPAPIs), cytotoxic compounds, Carcinogenic Mutagenic Reprotoxic (CMR) substances, etc.

We have dedicated labs for high toxicity compounds and potent materials and can safely handle high toxicity samples with Occupational Exposure Levels (OEL) of 1µg/m3.

Regulatory support

Our project managers and scientists have thorough understanding of European regulatory guidelines and work in compliance with the EP, USP or ICH international standards.

Our teams also have strong expertise and experience with regulatory dossiers. We can support our customers with the filling of their investigational files (IMPD and IND) and drug master files (DMF).