Johnson Matthey
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London, GB
Johnson Matthey’s vision is for a world that’s cleaner and healthier, today and future generations. We are leaders in sustainable technologies and we apply our science to solve our customer’s most complex problems. We work with customers and partners across markets from pharmaceutical and medical to automotive, industrial and chemical production.
Our specialist technologies provide a substantial toolkit for diverse complex chemistries. They include an unmatched portfolio of homogeneous and heterogeneous catalyst technologies; chiral synthesis including chemocatalysis and biocatalysis platforms; controlled substances; highly potent APIs; expertise in drug-conjugate and linker technologies; solid state sciences; manufacturing-scale chromatography and purification sciences; as well as process analytical technologies.
Johnson Matthey has leading capabilities in developing optimal polymorphs, salt forms, crystal morphologies and controlled particles through our PHARMORPHIX® solid state sciences offering. The selection of a specific crystal, or amorphous, form for a given active compound is a profoundly important step from clinical, legal and regulatory perspectives, and PHARMORPHIX®’s expertise can ensure appropriate API performance for your selected dosage form.
Scanning Electron Microscopy:
A range of instrumentation including benchtop and field emission SEM capabilities. Resolutions down to <1nm along with elemental composition. Cryogenic capabilities.
Transmission Electron Microscopy:
Providing structural, chemical and morphological information from micron to nano-scale regions of sample. Cryogenic capabilities.
Proof of concept and small scale micronized material supply using a FPS Labomill-1 jet mill.
Proof concept spray drying studies, including neat API, amorphous dispersions and co-crystal formation, using a Büchi Mini B-290.
The selection of a specific crystal form for a given API is a profoundly important step from clinical, legal and regulatory perspectives: for example, the dissolution rate and intrinsic solubility of different crystal forms is variable and can strongly influence bioavailability.
Pharmorphix’s expertise – we have conducted in excess of 400 polymorph screens, and worked on almost 40 compounds that are now commercial products – can ensure appropriate solid state performance for your selected dosage form.
A range of techniques, such as XRPD, DSC, Raman spectroscopy, Solid State NMR and GVS, available to quantify amorphous content in both drug substance and drug product samples.
Drug substance and drug product testing in buffered solutions and simulated fluids.
Sirius inForm and Omicron Research Ltd Distek Instrumentation.
Powerful surface analytical method, suitable for any non-volatile material, allowing quantitative chemical analysis through studying all elements, except hydrogen, simultaneously. Suitable applications include:
Bruker Avance Neo 600 MHz spectrometer and Bruker Avance III 400 MHz spectrometers. Selected pharmaceutical applications include:
Raman mapping drug product samples for polymorphic content and amorphous quantification.
Raman analysis of drug substance and drug product samples for polymorphic content and amorphous quantification.
Hygroscopicity measurement at RT to 50 degC.
Five DVS Intrinsic instruments by Surface Measurement Systems and Two Hiden IGASorp instruments.
Hiden instrumentation can also be used with organic solvents.
Classical resolution by diastereomeric salt formation:
Resolution by cocrystallisation.
Resolution by kinetic entrainment.
Construction of phase diagrams to ensure robust process development.
Poor oral bioavailability is increasingly an issue in the drug discovery process. Dosage form performance is one of the possible contributing factors to poor oral bioavailability. It is possible, therefore, to increase the dissolution rate and oral bioavailability of the API by modifying the physico-chemical properties of the API. When ionisable centres are present in the molecule, the preparation of an appropriate salt form which displays the right balance of solid state and physico-chemical properties is one of the most common approaches to modify the properties of the API and to enable the development of the corresponding API.
Pharmorphix has conducted in excess of 380 salt screening studies and our expertise can identify the most suitable salt for your selected dosage form, as well as generating additional intellectual property surrounding the solid state landscape of your molecule.
Pharmorphix has been undertaking cocrystal screening studies since 2004 , Including over 50 screens since 2016. We have developed cocrystals to improve a range of properties including:
Pharmorphix has developed cocrystals on a number of marketed drugs, including in the following indications:
In addition, Pharmorphix has experience generating the regulatory data required by both the FDA and EMA to confirm cocrystal formation, and subsequent in-vitro dissociation, and the location of the proton along the salt / cocrystal continuum.
Structure collection and determination, including absolute stereochemistry confirmation, for small molecules. Generation of comprehensive SCXRD reports, along with structure files (CIF, hkl, etc.), including ORTEP figures stereochemistry validation which can be used directly for regulatory and IP applications.
The SCXRD lab at JM Cambridge contains two fully automated and highly integrated Rigaku Oxford Diffraction dual source (Cu/Mo radiation) X-ray single crystal diffractometers:
Data collections can be performed at specific temperatures, anywhere from 80 K to 400 K, and variable temperature SCXRD studies can be performed within this temperature range.
Availability of both Mo and Cu radiation allows for a much wider range of sample types to be explored by X-ray diffraction. Highly absorbing materials containing heavy elements can be evaluated using Mo radiation. By contrast, Cu radiation is applicable for smaller, weaker diffracting organic samples and confirmation of absolute stereochemistry for samples containing only light atoms (C,H,N,O).
TA Instruments Discovery TGA and TA Instruments Q500 instrumentation.
Typical sample requirements ca. 10 mg.
TA Instruments Discovery DSC and TA Instruments Q2000 instrumentation for DSC analyses, including modulated DSC.
Typical sample requirements ca. 5 mg.
PANalytical Empyrean and Bruker D8 Advance instruments.
Including crystal structure determination from powder data.
Structure collection and determination, including absolute stereochemistry confirmation, for small molecules. Generation of comprehensive SCXRD reports, along with structure files (CIF, hkl, etc.), including ORTEP figures stereochemistry validation which can be used directly for regulatory and IP applications.
The SCXRD lab at JM Cambridge contains two fully automated and highly integrated Rigaku Oxford Diffraction dual source (Cu/Mo radiation) X-ray single crystal diffractometers:
Data collections can be performed at specific temperatures, anywhere from 80 K to 400 K, and variable temperature SCXRD studies can be performed within this temperature range.
Availability of both Mo and Cu radiation allows for a much wider range of sample types to be explored by X-ray diffraction. Highly absorbing materials containing heavy elements can be evaluated using Mo radiation. By contrast, Cu radiation is applicable for smaller, weaker diffracting organic samples and confirmation of absolute stereochemistry for samples containing only light atoms (C,H,N,O).
Structure collection and determination, including absolute stereochemistry confirmation, for small molecules. Generation of comprehensive SCXRD reports, along with structure files (CIF, hkl, etc.), including ORTEP figures stereochemistry validation which can be used directly for regulatory and IP applications.
Crystal growth projects to generate single crystals suitable for structure determination.
The SCXRD lab at JM Cambridge contains two fully automated and highly integrated Rigaku Oxford Diffraction dual source (Cu/Mo radiation) X-ray single crystal diffractometers:
Data collections can be performed at specific temperatures, anywhere from 80 K to 400 K, and variable temperature SCXRD studies can be performed within this temperature range.
Availability of both Mo and Cu radiation allows for a much wider range of sample types to be explored by X-ray diffraction. Highly absorbing materials containing heavy elements can be evaluated using Mo radiation. By contrast, Cu radiation is applicable for smaller, weaker diffracting organic samples and confirmation of absolute stereochemistry for samples containing only light atoms (C,H,N,O).
Variable temperature, variable humidity and vacuum XRPD capabilities.
XRPD analysis of drug substance and drug product samples, including computed tomography.
Polymorphic content and amorphous quantification.
Crystal structure determination from powder data.
PANalytical Empyrean, Bruker D8 Advance and Bruker C2 GADDS instruments.
Johnson Matthey has leading capabilities in developing optimal polymorphs, salt forms, crystal morphology and controlled particles through our PHARMORPHIX® solid form sciences. We offer one of the broadest and most reliable services to ensure effective identification, development and manufacture of your drug candidates and commercial products.
Pharmorphix has completed in excess of 2,000 customer projects in this area and our expertise and innovation has led to almost 40 APIs making the transition to market. Indeed, since 2014 over 20 % of the small molecule drugs approved by the FDA have previously been investigated at Pharmorphix. Our experience in solid state chemistry will ensure appropriate API performance for your selected dosage form.
Structure collection and determination, including absolute stereochemistry confirmation, for small molecules. Generation of comprehensive SCXRD reports, along with structure files (CIF, hkl, etc.), including ORTEP figures stereochemistry validation which can be used directly for regulatory and IP applications.
The SCXRD lab at JM Cambridge contains two fully automated and highly integrated Rigaku Oxford Diffraction dual source (Cu/Mo radiation) X-ray single crystal diffractometers:
Data collections can be performed at specific temperatures, anywhere from 80 K to 400 K, and variable temperature SCXRD studies can be performed within this temperature range.
Availability of both Mo and Cu radiation allows for a much wider range of sample types to be explored by X-ray diffraction. Highly absorbing materials containing heavy elements can be evaluated using Mo radiation. By contrast, Cu radiation is applicable for smaller, weaker diffracting organic samples and confirmation of absolute stereochemistry for samples containing only light atoms (C,H,N,O).
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