Cubi-tech is committed to doing our part in improving the health and lives of the public through the development of innovative drug products, optimisation of manufacturing process of pharmaceuticals and though offering advanced characterisation techniques to our customers and partners.
Please click on one of the below sections to find out more about what we do.
During the Preformulation stage of development, extensive characterisation is performed to establish the key physiochemical characteristics of a drug substance.
It is through the discovery of the physiochemical properties of the active ingredient that we are able to guide the appropriate formulation, production and delivery method for pre-clinical studies
Knowledge of a materials fundamental properties is essential to guide all future development of drug formulation, that’s why our staff at Cubi-Tech have the expertise to carry out a variety of physiochemical analysis techniques, including:
Thermal analysis is a vital tool to determine a materials physical structure, stability, miscibility, ideal processing temperatures. These factors are crucial for guiding drug development, allowing us to determine whether the substance is suited to its intended function or if not, giving insight into what properties need to be enhanced. In addition to this, knowing a drugs thermal properties is essential to determining the critical processing parameters in a variety of manufacturing processes.
Furthermore, thermal analysis is a valuable screening tool; allowing for polymorph identification and insight into whether an API is compatible with another material to form a multi-component drug product such as, cocrystals, salts, solvates, hydrates and solid dispersions.
As such, Cubi-Tech is equipped with a comprehensive thermal analysis suite, containing a differential scanning calorimeter (DSC) and a Thermogravimetric Analyzer (TGA) to provide comprehensive overview of a drugs thermal behaviour.
Characterising the inherent structural make up of a molecule is essential to understanding the way a drug will behave during development and a vital tool in verifying the quality of a substance. Structural analysis is a powerful tool for identifying exactly what, and how much of it, is present in your sample.
Cubi-Tech can offer a range of powerful structural characterisation tools to fit the needs of our customers including:
XRD is a an powerful technique used to analyse all kinds of matter. This rapid and non-destructive technique allows for the identification of the different crystalline phases which make up a given material. The properties and functions of a material is greatly influenced by its crystal structure, making XRD an indispensable technique for material characterisation, quality control and crystal structure determination. As such Cubi-tech staff have optimised a range of XRD techniques to analyse allow us to offer expedient, versatile and economic diffraction analysis.
Applications of this method include:
FTIR analysis is commonly considered the first approach in investigative chemistry due to the techniques sensitivity, speed, and simplicity in providing qualitative analysis to identify unknowns in a sample. FTIR utilises infrared light to scan samples and identify unique chemical patterns and bond properties based upon the light absorbed vs light reflected. Due to this FTIR is an extremely effective technique in quality control, helping identify unknowns, contaminants, additives, assist in material selection as well as being a highly reliable mechanism for determining polymer composition.
At Cubi-Tech we can provide advance FTIR analysis, with a high turnover at a competitive rate, as well as having our experts interpret the data to confidently guide you on the next steps to understanding your material.
Additional applications of FTIR include:
NMR is a powerful analytical technique for material characterisation. Through NMR it is possible to not only elucidate the structure and composition of your material, but to also understand the functions, reaction kinetics and dynamics of biopharmaceutical material.
Through placing the nuclei under a magnetic field, we are able to apply a Radio frequency energy to it, and once removed the nuclei will relax to its original state, releasing an electromagnetic pulse which is converted to spectral data. From this data it is possible to understand key aspects of a material, assisting in areas ranging from compositional analysis and quality control to drug discovery and quantitative analysis. Cubi-Tech offers advanced customisable services, from a team of experienced scientists to fit your materials needs.
The Applications of NMR include:
At Cubi-Tech, we offer a wide range of particle and powder characterisation services to help our clients best understand the physical properties of their materials so we can confidently advise on the best ways we can help optimise both the formulation and production.
Analysis of the properties of the single particle and powder is vital to understanding the manufacturing process as variables like Particle size and powder properties will influence physical properties, such powder flowability, compressibility and porosity which in turn, will impact processing, blending, tableting, dissolution, delivery and bioavailability.
Cubi-Tech offers a comprehensive range of tests utilising advanced characterisation equipment, operated by qualified and experienced staff to give you confidence that you know everything there is to know about your material.
Such physical testing includes:
Particle size analysis is crucial to understanding and controlling a wide range of properties. A materials particle size and morphology will effect a number of factors including; solubility, permeability, dissolution, flowability, compressibility and more. It is therefore important to determine the size and morphology as it will effect a drugs clinical performance and processability.
Cubi-Tech is equipped with a laser diffraction particle size analyser to ascertain its true particle size
In addition to this, the Laser diffractometer is able to asses the particle size distribution of your material, to help asses its uniformity.
In cases where further analysis of a particles morphology is necessary, Cubi-Tech staff have expertise in both a Scanning electron microscopy (SEM) and Atomic force Microscopy (AFM). Both these techniques allow high quality, high resolution imaging of a materials surface to evaluate its size, morphology and surface topography.
One of the most efficient and economical methods of enhancing the physical and chemical properties of drugs is to process them with other components. Multi-component drug systems describe a wide variety of dosage forms comprising of the active pharmaceutical ingredient (API) and a second substance (or in some cases a number of different substances) which enhances the APIs effects.
These can include:
However, a common issue in pharmaceutical development is finding the right combination to achieve the desired outcome for your product. Typical components used to enhance API include; Polymers (to act as carriers or protective matrixes), Organic and inorganic excipients, coformers, solvents and other active drug products. At Cubi-Tech we have a number of sophisticated computational and experimental screening facilities to intelligently select the best formers to work with your API
Our experts at Cubi-Tech have developed sophisticated computational intelligently predict the best drug/former combinations based on your needs.
Using advanced crystallography software our team have a number developed novel methods to narrow down a list of coformers which are most likely to interact with certain API. This is based on criteria such as Complementarity, molecule geometries, polarity, robust dimer formation, Hydrogen bond propensity or Ionic bond propensity in the case of salts. Using these techniques we are able to cut down on experimental testing, saving material and improving efficiency.
Using advanced software’s to help predict polymer or excipient miscibility, we are able to narrow down a list of likely candidates to for amorphous solid dispersions with a given API. Using principals such as Hanson and hillderbrand solubility parameters, we can confidently select the best polymer/excipient to suit your needs.
Hydrates/Solvates: Cubi-tech utilises a number of analysis software’s to accurately predict what solvents will react with API, to form crystal solvates, cutting down development costs and time.
After a shortlist of candidates are drawn up, Cubi-Tech will utilise its in house experimental thermal and structural screening systems including DSC, TGA, HSM, XRD to further narrow down the list of candidates. Subsequently, the successful candidates will under go a number of small scale experimental testing to asses if the predicted substance can be produced. These systems include Hot-Melt extrusion, Jet dispension, ball milling, spray drying and more. These experimental screening systems are designed to be rapid and consume little to no material to asses your materials validity before scaling up.
Cubi-Tech is also outfitted with the equipment and staff to screen for different polymorphs of your API. The slight differences in crystal form can often have pronounced differences to the physicochemical properties of the base API. Through combinations of DSC, TGA and XRD we are able to locate any different crystal forms of your drug for further development.
An essential part of pharmaceutical development is assessing the stability and shelf life of an API to ensure it is stable under a variety of conditions. In a global market, it is important to gauge whether or not a pharmaceutical product will retain its properties from different climates around the world.
Variants such as light, temperature and humidity can have a pronounced effect on the shelf life of a pharmaceutical and thus its commercial viability. Data generated from long term stability testing will help our clients establish the shelf life, storage condition recommendations, ideal packaging materials, reset periods, transport conditions and predict whether or not the product will meet legal approval.
At Cubi-tech can provide a number of stability testing and storage services in accordance with ICH and WHO guidelines for a variety of APIs, pharmacuticals, biopharmaceuticals, organics, medical devices and more.
Our stability units are fully validated to meet GMP approval and can be employed for both short and long term studies and a variety of enhanced conditions to replicate different climate zones.
Our stability units are monitored real time, with a system of different alarms to warn in advance if the temperature or humidity settings are becoming compromised, allowing us to ensure the validity of the experiments.
All stability chambers are kept secure, with restricted access and with all ingoing and outgoings logged to ensure your products safety.
Cubi-Tech operates back-up facilities in case of emergency, ensuring constant continuation of studies through whatever is thrown our way.
During the Preformulation stage of development, extensive characterisation is performed to establish the key physiochemical characteristics of a drug substance.
It is through the discovery of the physiochemical properties of the active ingredient that we are able to guide the appropriate formulation, production and delivery method for pre-clinical studies
Knowledge of a materials fundamental properties is essential to guide all future development of drug formulation, that’s why our staff at Cubi-Tech have the expertise to carry out a variety of physiochemical analysis techniques, including:
Thermal analysis is a vital tool to determine a materials physical structure, stability, miscibility, ideal processing temperatures. These factors are crucial for guiding drug development, allowing us to determine whether the substance is suited to its intended function or if not, giving insight into what properties need to be enhanced. In addition to this, knowing a drugs thermal properties is essential to determining the critical processing parameters in a variety of manufacturing processes.
Furthermore, thermal analysis is a valuable screening tool; allowing for polymorph identification and insight into whether an API is compatible with another material to form a multi-component drug product such as, cocrystals, salts, solvates, hydrates and solid dispersions.
As such, Cubi-Tech is equipped with a comprehensive thermal analysis suite, containing a differential scanning calorimeter (DSC) and a Thermogravimetric Analyzer (TGA) to provide comprehensive overview of a drugs thermal behaviour.
Characterising the inherent structural make up of a molecule is essential to understanding the way a drug will behave during development and a vital tool in verifying the quality of a substance. Structural analysis is a powerful tool for identifying exactly what, and how much of it, is present in your sample.
Cubi-Tech can offer a range of powerful structural characterisation tools to fit the needs of our customers including:
XRD is a an powerful technique used to analyse all kinds of matter. This rapid and non-destructive technique allows for the identification of the different crystalline phases which make up a given material. The properties and functions of a material is greatly influenced by its crystal structure, making XRD an indispensable technique for material characterisation, quality control and crystal structure determination. As such Cubi-tech staff have optimised a range of XRD techniques to analyse allow us to offer expedient, versatile and economic diffraction analysis.
Applications of this method include:
FTIR analysis is commonly considered the first approach in investigative chemistry due to the techniques sensitivity, speed, and simplicity in providing qualitative analysis to identify unknowns in a sample. FTIR utilises infrared light to scan samples and identify unique chemical patterns and bond properties based upon the light absorbed vs light reflected. Due to this FTIR is an extremely effective technique in quality control, helping identify unknowns, contaminants, additives, assist in material selection as well as being a highly reliable mechanism for determining polymer composition.
At Cubi-Tech we can provide advance FTIR analysis, with a high turnover at a competitive rate, as well as having our experts interpret the data to confidently guide you on the next steps to understanding your material.
Additional applications of FTIR include:
NMR is a powerful analytical technique for material characterisation. Through NMR it is possible to not only elucidate the structure and composition of your material, but to also understand the functions, reaction kinetics and dynamics of biopharmaceutical material.
Through placing the nuclei under a magnetic field, we are able to apply a Radio frequency energy to it, and once removed the nuclei will relax to its original state, releasing an electromagnetic pulse which is converted to spectral data. From this data it is possible to understand key aspects of a material, assisting in areas ranging from compositional analysis and quality control to drug discovery and quantitative analysis. Cubi-Tech offers advanced customisable services, from a team of experienced scientists to fit your materials needs.
The Applications of NMR include:
At Cubi-Tech, we offer a wide range of particle and powder characterisation services to help our clients best understand the physical properties of their materials so we can confidently advise on the best ways we can help optimise both the formulation and production.
Analysis of the properties of the single particle and powder is vital to understanding the manufacturing process as variables like Particle size and powder properties will influence physical properties, such powder flowability, compressibility and porosity which in turn, will impact processing, blending, tableting, dissolution, delivery and bioavailability.
Cubi-Tech offers a comprehensive range of tests utilising advanced characterisation equipment, operated by qualified and experienced staff to give you confidence that you know everything there is to know about your material.
Such physical testing includes:
Particle size analysis is crucial to understanding and controlling a wide range of properties. A materials particle size and morphology will effect a number of factors including; solubility, permeability, dissolution, flowability, compressibility and more. It is therefore important to determine the size and morphology as it will effect a drugs clinical performance and processability.
Cubi-Tech is equipped with a laser diffraction particle size analyser to ascertain its true particle size
In addition to this, the Laser diffractometer is able to asses the particle size distribution of your material, to help asses its uniformity.
In cases where further analysis of a particles morphology is necessary, Cubi-Tech staff have expertise in both a Scanning electron microscopy (SEM) and Atomic force Microscopy (AFM). Both these techniques allow high quality, high resolution imaging of a materials surface to evaluate its size, morphology and surface topography.
One of the most efficient and economical methods of enhancing the physical and chemical properties of drugs is to process them with other components. Multi-component drug systems describe a wide variety of dosage forms comprising of the active pharmaceutical ingredient (API) and a second substance (or in some cases a number of different substances) which enhances the APIs effects.
These can include:
However, a common issue in pharmaceutical development is finding the right combination to achieve the desired outcome for your product. Typical components used to enhance API include; Polymers (to act as carriers or protective matrixes), Organic and inorganic excipients, coformers, solvents and other active drug products. At Cubi-Tech we have a number of sophisticated computational and experimental screening facilities to intelligently select the best formers to work with your API
Our experts at Cubi-Tech have developed sophisticated computational intelligently predict the best drug/former combinations based on your needs.
Using advanced crystallography software our team have a number developed novel methods to narrow down a list of coformers which are most likely to interact with certain API. This is based on criteria such as Complementarity, molecule geometries, polarity, robust dimer formation, Hydrogen bond propensity or Ionic bond propensity in the case of salts. Using these techniques we are able to cut down on experimental testing, saving material and improving efficiency.
Using advanced software’s to help predict polymer or excipient miscibility, we are able to narrow down a list of likely candidates to for amorphous solid dispersions with a given API. Using principals such as Hanson and hillderbrand solubility parameters, we can confidently select the best polymer/excipient to suit your needs.
Hydrates/Solvates: Cubi-tech utilises a number of analysis software’s to accurately predict what solvents will react with API, to form crystal solvates, cutting down development costs and time.
After a shortlist of candidates are drawn up, Cubi-Tech will utilise its in house experimental thermal and structural screening systems including DSC, TGA, HSM, XRD to further narrow down the list of candidates. Subsequently, the successful candidates will under go a number of small scale experimental testing to asses if the predicted substance can be produced. These systems include Hot-Melt extrusion, Jet dispension, ball milling, spray drying and more. These experimental screening systems are designed to be rapid and consume little to no material to asses your materials validity before scaling up.
Cubi-Tech is also outfitted with the equipment and staff to screen for different polymorphs of your API. The slight differences in crystal form can often have pronounced differences to the physicochemical properties of the base API. Through combinations of DSC, TGA and XRD we are able to locate any different crystal forms of your drug for further development.
An essential part of pharmaceutical development is assessing the stability and shelf life of an API to ensure it is stable under a variety of conditions. In a global market, it is important to gauge whether or not a pharmaceutical product will retain its properties from different climates around the world.
Variants such as light, temperature and humidity can have a pronounced effect on the shelf life of a pharmaceutical and thus its commercial viability. Data generated from long term stability testing will help our clients establish the shelf life, storage condition recommendations, ideal packaging materials, reset periods, transport conditions and predict whether or not the product will meet legal approval.
At Cubi-tech can provide a number of stability testing and storage services in accordance with ICH and WHO guidelines for a variety of APIs, pharmacuticals, biopharmaceuticals, organics, medical devices and more.
Our stability units are fully validated to meet GMP approval and can be employed for both short and long term studies and a variety of enhanced conditions to replicate different climate zones.
Our stability units are monitored real time, with a system of different alarms to warn in advance if the temperature or humidity settings are becoming compromised, allowing us to ensure the validity of the experiments.
All stability chambers are kept secure, with restricted access and with all ingoing and outgoings logged to ensure your products safety.
Cubi-Tech operates back-up facilities in case of emergency, ensuring constant continuation of studies through whatever is thrown our way.
