One of the key challenges facing the pharmaceutical industry is the drive to create innovative, high-value products with ever-improving safety and quality profiles…but within shorter timescales and at lower cost.
No easy feat!
Now that the era of the blockbuster drug product is well and truly behind us, leading pharmaceutical innovators are seeking to evolve their products and development processes and unlock the value of their pipeline, while balancing lifecycle costs. This is driving a desire for the early identification of successful drug candidates, taking into account both the predicted efficacy of the candidate molecule and also the likelihood of formulation and manufacturing success.
A significant enabler to achieving development pipeline efficiency is the use of digital design approaches to predict product developability. For example, recent projects in the UK, such as the ADDoPT digital design project and the UK Government’s Made Smarter initiative, highlight opportunities for the early elimination of non-viable drug candidate formulations through the application of big data modelling methods. Key to this is access to advanced analytical techniques and relevant data.
This is where companies like Malvern Panalytical get involved!
Our aim here at Malvern Panalytical is to ease and improve our customers’ workflows so that better products can be developed more quickly and efficiently. We support our customers in determining which of our analytical techniques are relevant to the development of their products, and, equally importantly, we help them to ensure that these techniques are applied appropriately. Good technique selection and application results in good data quality, which minimizes the likelihood of poor decisions and formulation or manufacturing issues.
With this in mind, we have introduced a set of webinars aimed at helping pharmaceutical customers improve and simplify their selection of analytical methods for materials characterization. These seminars focus on the measurement of the Critical Material Attributes (CMAs) of particle size, solid form and elemental composition, each of which is highlighted as important in assessing formulation performance and safety within the regulatory guidance, including ICH Q3D and ICH Q6A.
The first webinar series discusses the importance of particle size in pharmaceutical formulations, and explores how, as a CMA, the particle size of both the Active Pharmaceutical Ingredients (APIs) and excipient ingredients impacts a product’s target performance profile.
The second webinar series investigates elemental analysis in pharmaceutical development and manufacture. The first seminar, Elemental Analysis – Simplify your Workflow, considers the use of X-ray Fluorescence for the detection of elemental impurities in pharmaceutical intermediates and final products, as an alternative to the traditional ICP-OES, ICP-MS and AAS methods. The upcoming seminar, Elemental Analysis – Reduce your Analytical Workload, will include a live demonstration of the Epsilon 4 benchtop XRF system, including system calibration, sample preparation, measurement and analysis.
Our third and final series will investigate the importance of robust pharmaceutical solid form analysis in ensuring that a product meets its target performance profile. It is vital to ensure that the API in a formulation is present in its correct polymorphic form, as undesired or unstable polymorphs may lead to a reduction in therapeutic effect or even an adverse effect in the patient.
Please register your interest in these events below. As always, we would love to hear your ideas and requests for future webinars, so please get in touch!