The Quality by Design (QbD) principles outlined by Jurong have found a natural home in the arena of pharmaceutical method development. This presentation will outline what QbD is, how it works within pharmaceutical development, and will provide some examples of the ‘fishbone’ diagrams which show the factors that should be considered when developing methods for laser diffraction and dynamic light scattering.

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– Who should attend?
Those who are involved in developing methods for the development/analysis of pharmaceuticals or in transferring methods between locations or instruments.
– What will you learn?
An understanding of QbD and the associated variables in two of the primary particle sizing techniques used today.

In this webinar we introduce a new DLS data capture process called Adaptive Correlation which addresses issues to provide a more complete and accurate characterization of your sample.
Whilst being able to measure particles of below 1 nm size, DLS is preferentially sensitive to larger particles due to the 6th power relationship between particle radius and scattering intensity. This means that sample preparation typically needs to be scrupulous, especially for low scattering samples such as proteins and biological molecules. The contribution to contaminants such as dust and aggregates can be mitigated by filtering, however this may not always be practical and constitutes a financial burden, both in terms of additional sample preparation time and consumables costs.

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– Who should attend?
Existing Zetasizer and competitor users who want to understand the benefits of Adaptive Correlation.
– Why attend?
To understand the benefits that Adaptive Correlation can offer over traditional correlation approvals.
– What will you learn?
How Adaptive Correlation works and the benefits it can offer such as faster measurements, more reliable data and less sample preparation.

This online demonstration is designed to get you up close and personal with the Morphologi 4 platform. You will be given an insider’s look at the instrument and its accessories via our lab webcam and follow the measurement of typical samples using the Morphologi 4 and Morphologi 4-ID, including Morphologically-Directed Raman Spectroscopy (MDRS®). This will introduce you to automated image analysis and the powerful Morphologi software to show you how the combination of size and shape parameters can be used to better understand your materials.

We will look at how a dry powder sample can be dispersed using the integrated sample dispersion unit. We will then run a quick measurement and take you through the software features available for interpreting the results. There will also be time to ask any questions that you have about image analysis and the Morphologi 4 and Morphologi 4- ID.

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– Who should attend?
People who have an interest in particle size and shape, Image analysis,
Raman analysis of particles, pharmaceutical product development and deformulation, metal powder manufacturers, food, forensics, anybody who has recently sent in evaluation samples.
– What will you learn?
How the Morphologi 4 instrument and platform operates,
automated powder dispersion for reproducible sample presentation,
other sample presentation options, automated image capture, data processing and analysis and batch comparison.

Antibody-Drug Conjugates (ADCs) are a rapidly growing class of oncology therapeutics wherein a potent cytotoxic drug is conjugated to the antibody molecule. The impact of drug conjugation on the antibody’s conformation needs to be evaluated. Additionally, the drug conjugation can also affect various physical properties of the antibody molecule which in turn can affect its stability and aggregation propensity. This presentation summarizes results from our study on aggregation of a lysine-conjugated ADC and its unconjugated mAb under accelerated heat and agitation stresses. Additionally, we also highlight spectroscopic and DSC based analytical approaches that can be used to detect subtle differences between the ADC and mAb.

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– Who should attend?
Anyone interested in biopharmaceuticals, especially antibody-based therapeutics
– What will you learn?
The biophysical properties of ADCs, some analytical considerations for ADCs, and the impact of drug conjugation on protein aggregation

Polymers are extensively used for tissue repair and replacement in the form of implantable biomedical scaffolds. Examples include surgical meshes, cardiovascular stents, nerve conduits, and bone regeneration scaffolds and fixation devices. Thermal processing is a common denominator in all these applications. Rather than discuss use of the rheometer to study polymer rheology, on which a large body of literature exists, the webinar will focus on the use of capillary rheometer as a tool for optimizing the process parameters with a few grams of polymer before using up hundreds of grams in extruders. Capillary rheometer is indispensable in the evaluation of degradable polymers that have a tight window for processing. We have taken advantage of the temperature stability of the rheometer to assess the thermal stability of polymers, and drugs and processing aids that are incorporated into polymers.

A rheometer can also be used as a small-scale extruder to screen a large number of polymers by extruding ~ 100 m diameter fibers from which their mechanical and degradation behavior can be ascertained. We have also used rheology to referee the molecular weight determinations of a series of polymers. Some examples of recent successes using the rheometer in our laboratory are the optimization of the conditions for extrusion of fibers from our tyrosine derived polymers, extrusion of ~ 5 mm rods for machining into bone fixation screws, evaluation polymers for 3D printing applications, and for extruding the 1.75 mm diameter filaments for use with 3D printers that use fusion

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Who should attend?
Anybody using polymer extrusion processes who would like to know how capillary rheometry can be used to optimize processing conditions.

Why attend?
To learn how capillary rheometry can be used to screen large numbers of polymers for stability and processing prior to larger scale extrusion, thereby saving time and money.

What will you learn?
How capillary rheometry can be used to screen biodegradable polymers and additives for thermal stability and process-ability with just a few grams of sample.

Optimize your processes and comply with stringent international regulations by fast and accurate elemental analysis. Suitable for any industry, Epsilon 4 is the next step in energy dispersive XRF.

Combining the latest advances in excitation and detection technology with mature software and a smart design, the analytical performance of the new benchtop instrument approaches the one of more powerful and floor-standing spectrometers.

Product managers Lieven Kempenaers and Michel Zoontjes will demonstrate the new Epsilon 4 during this free webinar. A demonstration shows the ease-of-use, of the instrument, from setting up a measurement, creating dedicated calibrations to analyzing routine samples. Discover what impact the new Epsilon 4 could have on your daily operations.

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Who should attend?
Anyone interested in EDXRF , Lab managers, quality control specialists, geologists, material science and analytical chemistry, university staff.

Why attend?
To learn about the benefits of Epsilon XRF benchtops as an elemental analysis technique. Learn how this latest generation technology brings the performance of floor standing systems to the benchtop.

What will you learn?
The latest development in EDXRF ,new applications in reach of benchtops +amp;amp; ease-of-use of Epsilon benchtops.

This demonstration will give you an introduction to measuring particle size using the Mastersizer 3000. You will be able to take a look at the Mastersizer 3000 and its accessories and we will share the Mastersizer 3000 software with you so that you can follow the measurement process. We will look at the dispersion of a sample measured in liquid using the Hydro EV accessory. This will introduce you to a range of features in the Mastersizer 3000 software, such as the trending of parameters during the measurement, which is a great aid to method development. We will also show you the data quality feature which gives you feedback on the quality of your measurements as well as on the stability of your results.

Next, we will make some measurements using the Aero dry dispersion unit, to show how easily you can set up a method to get reproducible data on bulk dry materials. There will also be time to ask any questions that you have about laser diffraction and the Mastersizer 3000.

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Who should attend?
Anyone with an interest in particle sizing and laser diffraction
Anyone with an interest in the Mastersizer 3000
Anyone who would like to see the process of wet and dry measurements using the Mastersizer 3000.
Anyone who has sent in samples for a feasibility study and would like to see the measurement process.

Why attend?
To learn about how to measure particle size using laser diffraction and the Mastersizer 3000.
To see the Mastersizer 3000 in action and follow the wet and dry measurement processes live.
To find out more about the Mastersizer 3000 and its accessories
To learn about the software features available in the Mastersizer 3000

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In the face of increasing pressure on health care access and costs, regulators such as the US FDA are actively seeking ways to enable the rapid development and launch of new generic medicines. Within this, there has been significant focus on complex products, such as OINDP (Orally Inhaled and Nasal Drug Products) and topical creams, where the delivery method and site of action makes bioequivalence assessments difficult using traditional in vivo approaches. As a result, many off-patent complex drug products are not subject to generic competition. The US FDA has therefore committed to providing improved scientific and regulatory clarity with respect to complex generic drug approvals, leading to the publication of product-specific guidance documents which outline the requirements for assessing in vitro bioequivalence by considering physicochemical (Q3) equivalence. This webinar will consider the workflows associated with evaluation of physicochemical (Q3) bioequivalence with reference to the measurement solutions offered by Malvern Panalytical.

In this webinar, we will introduce a toolbox of physicochemical analysis techniques which are increasingly being employed to assist with the evaluation of physicochemical (Q3) bioequivalence for complex generic drug products in vitro. Example case studies will be shared, including data on topical cream and nasal spray formulations.

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– Who should attend?
Researchers engaged in complex generic product formulation development,
scientists engaged in applying in vitro techniques for bio-equivalence studies +amp;amp; lead scientists considering the technique requirements for assessing bio-equivalence.
– What will you learn?
• Why physicochemical characterization studies are important in assessing in vitro bioequivalence, particularly for complex generic products
• Which physicochemical properties are considered in assessing Q3 equivalence
Which techniques provide useful information for Q3 equivalence studies