Rapid Generic Pharmaceutical Product Development
In a recent newsletter, the US FDA highlighted the important role Morphologically-Directed Raman Spectroscopy (MRDS) can play in supporting the development of generic drug products. The component-specific particle size and shape distribution data generated by this technique can aid sponsors with pinpointing the formulation characteristics and possible manufacturing route used for a Reference Listed Drug (RLD) product, and provides the in vitro data required to support bioequivalence studies. This webinar will consider the workflow associated with RLD deformulation and will introduce the technique of MDRS and its application in developing complex generics including Oral Solid Dose (OSD), Topical and OINDP formulations.
TheOx Advanced® is the new version of the world-renowned TheOx®. Improved analytical performance, additional safety features and increased robustness are only a few examples of the benefits of this newest generation of fusion instruments.
Designed by our experts in sample preparation by fusion to suit our customers’ ever-changing needs, it guarantees high analytical performance and brings a quick return on investment. It also ensures a high fusion success rate, for all the range of samples prepared by fusion for XRF and ICP analysis, from mining to cosmetic samples, including refractories, cement, catalysts, coal, ferro-alloys and many more.
To learn more about how the TheOx Advanced® can help you fulfill your needs regarding sample preparation by fusion, register to one of our free webinar sessions NOW!
Webinar duration: 20 minutes
Panelist: Chantal Audet
Chantal Audet is Product Manager for the instruments department at Claisse since 2010. Chantal joined Claisse in 2004 as a Technical Representative for different territories such as South America, Asia and the United States. This field experience with sample preparation by fusion allows her to deeply understand the customers’ needs and participate in product development accordingly. Our team joined PANalytical in 2014, and our expertise fused with theirs results in the creation of outstanding products due to our joined expertise.
Spray drying, which produces a dry powder from a liquid or slurry, is one of the most popularly-used continuous drying processes in which a liquid in the form of an emulsion, wet slurry or suspension is sprayed via a spray nozzle or a rotary atomizer into a drying chamber. The process is used across a range of industries including foods, pharmaceuticals, ceramics and metallurgical powders and produces granules that are highly spherical in shape and have excellent fluidity. In Part 2 of this two part webinar series we look at how Malvern's characterisation technologies can be used to analyze spray dried products to improve spray drying processes and quality control protocols.
This July, our webinar focuses on the specific application of Grains Analysis.
In this webinar you will learn:
- General considerations for the creation of quantitative NIR models, including best practices and practical guidelines.
- Typical applications of commercial grain collection – examples include: corn, soy, barley
- Example of the use of ASD system was used in a root crop improvement project in Vanuatu
- Example of how ASD systems can be used in seed production to monitor moisture content of seed, which is critically important for the storage and germination of seeds.
Understanding the stability of biological formulations – including their propensity to aggregate - is one of the primary requirements of moving drug candidates through the development pipeline. Biopharmaceutical companies will often establish a target molecule profile, with the intention of ensuring that poor candidates are removed from the development process as early as possible. Formulation stability and aggregation potential are core properties for the target molecule profile, to ensure an acceptable drug shelf life, good efficacy and safety profiles, and to minimize the risk of unwanted particle formation.
This presentation will introduce the complementary nature of Taylor Dispersion Analysis (TDA) as a method of measuring protein size and understanding the aggregation potential of a biological formulation.
Sodium layered oxides, NaxMO2 (M = Ti – Cu), show great promises as positive electrode material candidates for Na-ion batteries. However, detailed structural analysis of these materials presents many difficulties owing to their reactivity in ambient conditions, numerous structural transitions as a function of the sodium content and extended stacking fault occasionally resulting in partial amorphization of the sample.
This webinar will cover the study of P2-NaxFe1/2Mn1/2O2 positive electrode material focusing on the powder X-ray diffraction (PXRD) data collection strategies used to address the challenges inherent to sodium layered oxide in general. The wealth of information accessible owing to the outstanding versatility of the multipurpose Empyrean platform will be exemplified through the following techniques:
• Debye-Scherrer geometry to characterized unstable phases.
• Thermodiffraction under controlled atmosphere to understand the reactivity of the material.
• Operando monitoring of the crystal structure of the electrode.
• Pair Distribution Function (PDF) analysis to reveal the structure of semi-crystalline compounds.
Thursday July 28, 2016
Expected duration 1 hour
Guest Panelist: Victor Duffort - Post doc at Waterloo University, currently working at the CNRS in France
Co-panelist: Gwilherm Nenert - Product Specialist XRD - PANalytical B.V. Almelo the Netherlands
The Kinexus DSR demo at your desk will provide an overview of the instrument operation for day to day routine asphalt testing for QC and research, as well as cover many unique features designed to provide improved lab efficiency. Participants will see the instrument and software performing several standard AASHTO/ASTM tests live, demonstrating how the advanced capabilities of the Kinexus can provide additional insight in to asphalt properties, for example;
- TruGrade of unknown binders
- Determination of mixing and compaction temperatures
- Automated data collection and generation of master curves
- Tack coat tack testing, softening point, generation of BBR results
- Viscosity measurements, binder fatigue and relationship to penetration
- Forced ductility & elastic recovery.
In addition we will show how the Kinexus software can be used to improve lab efficiency and internal documentation management through statistical quality control, automated reporting and use of an integrated materials database for tracking product aspects by terminal location, grade, tank, supplier or even by project. Lastly, we will demonstrate how the innovative SOP design functionality of the rSpace operating system can be used to recrete existing company procedures or to design new robust procedures .