We are a growing company specialised in R&D Process Chemistry, Solid Form Development, and Medicinal Chemistry. Our strengths are Asymmetric Chemistry and cocrystallisation technologies.
We can handle almost any kind of project related to organic chemistry, both from a technical and project management point of view. The most challenging projects are part of our day-to-day routine.
In addition to offering services to industry as a Contract Research Organisation (CRO), we also develop various internal research programs which are later commercialised through a variety of agreements and licensing options.
Our mission is to provide fully integrated chemistry services for the worldwide fine chemical, pharmaceutical and biotechnology industry with the aim to contribute all the way from initial research to a scalable route for manufacturing.
What makes us stand out from the crowd
The suitability of a compound or of a solid formulation depends on its physical characteristics, such as its crystalline or amorphous nature, its polymorphic identity and the presence of impurities or patented solid forms.
At Enantia we are experts in the analysis and characterisation of the solid state phase of a compound. We can help you not only in the design of the right analyses but also the interpretation of the results to get the maximum information as fast and comprehensively as possible.
To establish the quality of drug products and substances, our services include:
Our crystallographic and analytic team plan the most relevant analyses, execute them and interpret the results for you. Selecting the right techniques and experimental conditions will be sure to obtain the required information at any stage of a project.
One of the aims of a solid form screen is to find the optimal solid form with the ideal characteristics for development of a given substance. The choice of the form for development is usually a fine balance between physical, chemical, pharmaceutical and biopharmaceutical properties. Different screens can be performed at different points in the development process, depending on the information needed and the goal of the screen.
Enantia has its roots deep in solid forms screening. Techniques such as grinding, slurring, evaporation and crystallisation among others combined with our analytical capabilities allow us to identify new solid forms in an effective and exhaustive way. Enantia uses XRPD as a routine analytical technique during the screening stage. A complete solid form screening includes polymorph, amorphous, salt and cocrystal screening. Any of these studies can be undertaken separately or combined depending on our client interests.
Amorphous forms: The use of a variety of techniques allowing the formation of amorphous solids such as solvent evaporation, freeze drying, desolvation, melt quenching, grinding and fast precipitation.
Polymorph screening: identification of new polymorphs, solvates or hydrates is possible applying the adequate techniques to favour the appearance of stable and metastable forms.
Salt and cocrystal screening: Both our salt and cocrystal programs are based around two key factors: Strategically planned experiments, and the application of internal knowhow. These factors allow us to tackle the more ambitious projects with speed and confidence. During a cocrystal screen, special attention is paid to the solid state. The presence of a conformer or the use specific procedures of a cocrystal screen can favour the formation of new polymorphs even for compounds which have previously been studies in depth by the rest of the scientific community.
In all of the aforementioned options, preliminary characterisation of the newly found forms is usually performed to allow us to select the most promising one for the development phase. The properties measured at this stage might are project-dependent and rely on the final objective of the screen. Some of the most usual measured properties are solubility, chemical and crystalline stability under accelerated ICH conditions and hydroscopicity.
The big advantage of cocrystals compared to salts is that cocrystallisation is also applicable to non- ionisable molecules where salt formation is not possible. Compared to amorphous solid forms, cocrystals tend to be more stable and have a more predictable behaviour. Cocrystals are also less prone to polymorphic transformations due to the higher complexity of their crystal structure when compared to single component systems, thus avoiding undesirable downstream processing surprises.
As a result of the increasing relevance of these solid forms, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guideline documents related to their regulatory classification.
We have been a pioneer in the cocrystal field, working in the area since 2006 and gaining significant expertise. Cocrystals offer great potential:
During a cocrystal screen, special attention is paid to the solid state. The presence of a coformer or the use specific procedures of a cocrystal screen can favour the formation of new polymorphs even for compounds which have previously been studies in depth by the rest of the scientific community.
Over the last years, the number of pharmaceutical cocrystals has been increasing dramatically. Their novelty, utility and not obvious preparation make cocrystals an interesting approach from the point of view of intellectual property. In the case of commercial APIs, a patent of a cocrystal with better drug properties than previously known forms could be of high commercial value.
Cocrystals do not involve structural modification of the parent molecules, therefore, in the case of designing cocrystals of marketed drugs, their development programs (including clinical trials) will be significantly shorter and less risky than those of New Chemical Entities (NCEs).
Both our salt and cocrystal programs are based around two key factors: Strategically planned experiments, and the application of internal knowhow. These factors allow us to tackle the more ambitious projects with speed and confidence.
When extra sensitivity is needed in either single crystal (scXRD) or powder x-ray diffraction (PXRD), synchrotron diffraction is the preferred method of choice for modern API producers and pharmaceutical companies.
At Enantia we use the ALBA synchrotron on nearly a weekly basis in order to resolve our clients more challenging projects
Identification of new polymorphs, solvates or hydrates is possible applying the adequate techniques to favour the appearance of stable and metastable forms.
Enantia's holistic approach starts from an extensive bibliographic and IP search, which is then combined with brainstorming creative synthetic routes to target. A dynamic academic and industrial scientific board contributes to the design of new routes of synthesis, which are scouted in our laboratories.
The best identified route is then scaled-up and critical parameters are developed to ensure a quality and robust process for the production of the target molecule.
Fluent communication and transparency are always maintained with periodic meetings, conference calls and reports, all tailored to our clients needs, which facilitate a rapid and accurate technology transfer process. Learn more about our working principles.
We can tackle almost every kind of organic chemistry project although we are known as experts in the field of asymmetric synthesis.
Moreover, we are able to rapidly satisfy custom synthesis requests up to kilo-lab scale in-house, such as the synthesis of:
Our manufacturing partners can tackle projects which need special technologies like high pressure hydrogenations and low temperature reactions. If you additionally need any chemical development we can offer you an integrated service taking care of your project at any stage and moving it forward selecting the most suitable manufacture partner for your process. In any case the quality of the service and confidentiality will follow the highest standards.
Enantia's medicinal chemistry platform has a solid background in the design and synthesis of small molecules as ligands for a broad range of therapeutic targets, including GPCRs, enzymes, kinases, ion channels, and nuclear receptors among others. Combining our MedChem team with state-of-the-art facilities, we can contribute to different stages of a drug discovery program.
More and more the regulatory agencies are asking for our customers to demonstrate the amount of amorphous content of a product. At Enantia we have the know-how to quantify this to a high level of sensitivity. We have sucessfully completed this for our clients, transferring the developed methods so they can control the amount of amorphous with accuracy in every batch.
Do not hesitate to contact us to learn more
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