Drug Development Technologies
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Malvern has a wide range of characterisation technologies that can be used to accelerate the drug development process. Solutions range from tools that can run reliably and unattended, to systems that provide information on several key attributes in a single analysis such as particle size, shape, and chemical identity or molecular weight, size and concentration.
Malvern's instruments are deployed across the pharmaceutical industry in discovery, development and manufacturing. Work-flow efficiencies may be achieved when these tools are used in conjunction with each other.
Whether developing new, ground-breaking drugs or generic formulations, both the time and cost associated with pharmaceutical development is significant.
Malvern is focused on providing well-designed, innovative analytical instruments, which follow the quality by design (QbD) ethos, in the fields of drug discovery, chemical and formulation development and pharmaceutical manufacturing.
We understand what is involved in the development and manufacturing of a drug product and the requirements to measure the critical material attributes (CMA), as well as critical quality attributes (CQAs) affecting the critical process parameters (CPP) in the manufacturing process.
Molecule discovery tools
High throughput screening of large libraries of chemical compounds is the dominant technique used in early stage drug discovery, with dynamic light scattering being the optimum tool.
Being able to measure very small particle size at low concentrations, it is ideally suited as a screening tool for identifying even small levels of aggregation and potential inhibition.
Molecule optimisation with laser diffraction
In order to monitor efficacy of the suspension accurately, administering trial drug candidates in this form requires accurate, repeatable and validatable control of the active ingredient's particle size, often on limited sample volumes.
Laser diffraction is the best tool to meet these pre-formulation requirements. This technique provides particle size distribution of nano-scale material, while also having a wide dynamic range.
Chemical development for drug delivery
When characterising bioavailability or bioequivalence of nasally administered drugs, in support of new drug applications (NDAs) or abbreviated new drug applications (ANDAs), for nasal aerosols and sprays, the US Food and Drug Administration (FDA) recommends several tests.
In cases where the active component or components are suspensions, one important attribute is the drug particle size distribution. A laser diffraction system fit for this purpose must be able to rapidly measure obscuration (optical concentration), in addition to changes in droplet size distribution and span in real-time over the life of a single actuation from the drug delivery device.
Formulation development of drugs
The size of a liposomal vesicle plays a pivotal role in the pharmacokinetic and pharmacodynamics attributes of chemotherapeutic drugs, with the liposome acting as a carrier of the drug to the site of action and dynamic light scattering can be an effective technique.
Triple-detection size exclusion chromatography (TD-SEC) can accurately characterise polymer excipient molecular size and weight and avoid incorrect determination. The conditions of a tablet coating process can be simulated using a rotational rheometer system.
The viscosity of the liquid coating is measured initially under low stress conditions to quantify its full structure, then at high shear rates to simulate spraying, and again at low stress conditions to assess the viscosity rebuild with time.
Online particle analysis for drug manufacturing
Granulation can improve the ease of handling of powder blends and prevents the segregation of fine constituents, improving consistency in subsequent process steps, principally tableting.
To improve the efficiency of the milling operation, and deliver more consistent milled particle sizes, online particle-size analysis is a solution for continuous milling monitoring and control. In addition, measurements made by the online analyser can control the process through a closed loop with the mill's programmable logic controller (PLC).
Founded in the late-1960s, Malvern Instruments is now one of the world's leading materials and biophysical characterisation companies.
Having built on a long-established reputation for innovation in particle sizing, the company today is highly respected for its technology and applications leadership in areas that range from particle, protein and macromolecule characterisation through to rheological properties measurement and into process optimisation.
Malvern understands that when a customer chooses to invest in a Malvern product, that customer is making a serious financial commitment. We take this seriously, and strive to ensure that the customer is reminded with every interaction with us that they have made an excellent choice, and that they will receive exceptional and personalised support for the many years they will have our equipment.
Please contact us with your business enquiry.
Malvern Instruments Ltd
Enigma Business Park
+44 1684 892 456
+44 1684 892 789
Malvern NanoSight LM10
Malvern NanoSight NS300
Malvern NanoSight NS500
Available White Papers
Calculating Pressure, Pipe Measurement, and Flow Rate Requirements for a Non-Newtonian Fluid When pumping fluids over long distances, the required pressure, pipe diameter, and flow rate is calculated. For non-Newtonian fluids, it is sufficient to consider them as power law fluids, in terms of processing, due to the shear rates.
Stability Characterisation Using Differential Scanning Calorimetry An important parameter in production, manufacturing, formulation, and long-term storage, protein stability has large effects on biopharmaceutical products and higher stability means for greater profits and less product waste.
Top Eight Reasons to Update Your DSC Analysis System Differential Scanning Calorimetry (DSC) data is used to advance stable and developable proteins into the pipeline, while optimising process and formulation conditions to maintain stability between manufacture and storage.
How Suspension Rheology is Effected by Particle Characteristics This whitepaper discusses the effects of particle properties on suspension viscosity and rheological behaviour.
Introducing Morphologically Directed Raman Spectroscopy Drug formulation, an integral step in the regulated pharmaceutical industry, involves the careful blending and processing of precisely specified and measured components to create a final product that can be administered to deliver the required clinical dose.