Near Infrared spectroscopy as a great PAT tool for pharmaceutical processes-from raw material ID, integrated process control and to final product testing.
This webinar will focus on benefits of using NIR spectroscopy in several pharmaceutical processes. Examples of NIR application for raw material ID, process control testing and final product will be given. Challenges in implementing NIR spectroscopy in the analytical process will be discussed.
Near infrared spectrometers have long been the PAT tools of choice for pharmaceutical and industrial scientists seeking to gain physical and chemical information from their samples. More recently, the development of fast and inexpensive miniature NIR instruments has greatly facilitated real-time in-line monitoring of multiple unit operations within a process. NIR can be used as a supervisory tool for multiple critical quality attributes of a drug product. Deviations from the acceptable ranges can be acted on in real-time based upon closed-loop control strategies.
This webinar discusses how miniaturised spectrometers facilitate testing of different control schemes with the goal of enabling real-time feedback control of continuous manufacturing processes.
> Chris Pederson, Product Applications Engineer, Viavi Solutions
Chris will present the principle of operation of the linear variable filter-based miniature NIR spectrometers, i.e., the MicroNIR Spectrometers developed by Viavi Solutions. He will also share key performance attributes of these ultra-compact MicroNIR products, and their applications in the pharmaceutical industry.
> Krizia M. Karry, PhD Candidate at Rutgers University (now with BMS)
Krizia will present results of the MicroNIR spectrometer and its application for testing various control schemes and enabling real time feedback control of a continuous manufacturing process for tablets.
Presentation 1: Jason Causon, Senior Applications Specialist, Sciex
Development of bioanalytical LC-MS methods for the detection of therapeutic peptides and the proteolytic fragments of larger proteins and antibodies is growing along with the increasing number of peptide and protein drugs entering clinical research and development. Development of these methods present challenges that are different to small molecule method development because of the multiple charge states possible for a given peptide, the abundance of product ion possibilities and the large number of proteolytic fragments possible from a protein digest. In addition to optimizing for sensitivity, on-column HPLC method development is time consuming for the same reasons. In this webinar we present an automated tuning and optimization workflow with on-column validation using DiscoveryQuantTM 3.0 software with the new ChromaTune feature to overcome some of these challenges and make the optimization of peptide MRM methods easier and less time consuming.
Presentation 2: Remco van Soest, Product Manager, Sciex
Electrospray Ionization efficiency increases at lower flow rates. In this Webinar we will discuss how microLC can help you improve sensitivity in sample limited applications in bio-analysis by LC-MS. In order to analyse the same volume of sample as is typically injected in a conventional LC-MS system, up to 50 µL, we have developed a microLC system that allows for fast on-line pre-concentration on a short trap column. Because of the higher flow rates that can be used for loading the sample on the trap-column, sample throughput is not affected by using microLC flow rates for the LC-MS analysis.
Benefits and applications of handheld Raman and how it can help to facilitate compliance with PIC/S..
This webcast will discuss the benefits and applications of handheld Raman, including the reasons the industry is interested in the technology, data integrity, method development, how samples are scanned, and challenges that have been conquered. We’ll also discuss PIC/S and how it is unifying the regulatory perspective globally, currently including 41 member countries with applications of Japan and Korea under review. We’ll discuss how these regulations are moving towards 100% container testing globally and how handheld Raman technology can help to achieve it, as well as the importance of validation of instrumentation and methodologies.
Near-IR (NIR) analysis has already been utilized with great success in the food and feed industries. This webinar will discuss how recent advances in hardware through the use of Fourier-transform spectroscopy now enables the NIR user to realize the benefits of improved spectral resolution, sensitivity, and calibration transfer, ultimately leading to better control limits than previously possible. New software tools for data management across NIR networks will also be discussed.Read more >
Semiconductor nanostructures possess a number of applications in solar energy conversion. This includes using colloidal quantum dots in solar cells and, more recently, using analogous nanostructures such as nanowires (NWs) and nanosheets (NSs) in photocatalytic applications. In this presentation, we describe recent work to understand the photocatalytic response of solution-synthesized CdSe NWs and CdS NSs within the context of hydrogen generation. Various CdSe NW- and CdS NS-based systems such as core/shell structures and hybrid metal nanoparticle/semiconductor hybrid systems have been studied. In all cases, femtosecond transient differential absorption spectroscopy has been used to reveal relevant carrier relaxation processes in these materials as well as the flow of charges across the different heterointerfaces that are present. By correlating these transient absorption kinetics to results from accompanying hydrogen generation quantum yield measurements, we have, in turn, rationalized the response of these materials, clarifying the role that different heterojunctions play in establishing both charge separation and hydrogen generation efficiencies.Read more >
Coal power plant control systems have progressively evolved to meet the growing demand for efficient and flexible power generation whilst maintaining low emissions. In particular, optimisation of the combustion process has required increased use of online monitoring technologies and the replacement of standard control loops with more advanced algorithms
capable of handling multivariable systems. Improved stoichiometric control can be achieved with
coal and air flow sensors or imaging and spectral analysis of the flame itself, whilst in-situ laser absorption spectroscopy provides a means of mapping CO and O2 distribution in hot regions of the furnace. Modern plant control systems are able to draw on a range of computational
techniques to determine the appropriate control response, including artificial intelligence which
mimics the actions of expert operators and complex empirical models built from operational data.
New sensor technologies are also being researched to further improve control and to withstand the high temperature and corrosive environments of advanced coal plant and gasifiers. Increased use of optical technologies is of particular interest, with sensors based on optical fibres able to perform low noise, highly sensitive, and distributed measurements at high temperatures.
Microelectronic fabrication techniques and newly developed high temperature materials are also being combined to develop miniaturised devices which provide a robust and low cost solution for in-situ monitoring of gases and other parameters. These new sensors can be integrated with wireless communication technology and self-powering systems to facilitate the deployment of distributed sensor networks and monitoring of inaccessible locations. Using principles of self-organisation to optimise their output, such networks may play a growing role in future control systems.
Accelerating Pharma R&D with Novel MS Applications for High Throughput Screening (HTS), Drug Imaging and Integrating MS and NMR data for high confidence structure verification of small molecules.
This webinar will introduce novel MS and NMR solutions and its applications in pharmaceutical research:
> NMR Spectroscopy and Mass Spectrometry are two fundamental techniques for small molecule structure verification. Bruker FUSION-SV - a new software solution for comprehensive fully automated small molecule structure verification – simplifies and accelerates the drug design and discovery phases in the pharmaceutical industry significantly. The new Bruker FUSION-SV™ is a software solution integrating high resolution accurate mass (HRAM) data and complementary NMR data, into one result - increasing significantly the specificity and throughput for small organic molecule structure verification. Synthesis chemists will get a prompt result without being an expert spectroscopist.
> Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) instruments are ideally suited for high throughput screening (HTS) in drug discovery. Not only speed, simplicity and robustness are the convincing arguments for MALDI-TOF MS but the inherent strength of a label- and solvent-free technique. The webinar will explain the technique and advantages of MALDI-TOF MS and present automation solutions for highest throughput and speed (less than 1 second per sample).
> Finally the webinar will describe how the MALDI technology is used for small molecule imaging when coupled to modern 7 T (Tesla) FT-MS instrumentation. Drugs and metabolites can be visualized and distinguished one from the other directly measured from tissue samples. These results can be linked with histological information derived from the very same tissue, giving new insights into drug action and toxicity.
Near-infrared (NIR) spectroscopy offers users the capability to make rapid ID or quantitative measurements for a multitude of applications. Additionally, an essential feature for NIR use is the ability to transfer successful calibrations to other NIR spectrophotometers. Many manufacturers who use NIR for raw material identification and/or quantification of components in materials have the need to utilize multiple NIR spectrophotometers throughout their facilities. In these cases, it is essential to be able to develop calibrations using spectra generated on one NIR spectrophotometer and then transfer the calibrations to other NIR spectrophotometers at different locations. Another situation necessitating efficient calibration transfer occurs when manufacturers may need to replace outdated NIR spectrophotometers but still want to minimize time and resources by adapting the functioning calibrations that are in use. Such transfers allow users to reproduce existing NIR methods or replace older hardware platforms with minimal effort. In achieving transfer, there must be consideration for the type of instrumentation involved in the transfer, software tools available, calibration development, mathematical transformations, and model optimization.
In this presentation, specific examples of calibrations transferred to Buchi spectrometers will be used to present a methodology for effective NIR calibration transfer across either identical or different vendor hardware platforms.
Many dietary supplement companies are turning to near-IR (NIR) as a means of performing rapid and unambiguous ID testing to be in compliance with current regulations. Although NIR is established in the pharmaceutical industry for this purpose, its application in the dietary supplement industry has special challenges. In particular, usually hundreds of raw materials need to be identified and individual materials may possess significant lot to lot variation and yet be similar in composition to other materials. This presentation will cover proven successful strategies that have enabled optimal efficiency in the implementation of NIR, dealing with specific steps such as installation, method development, validation, and routine analysis.Read more >
The Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives have been of interest for pharmaceutical manufacturing in the last years. Implementation of PAT/QbD approach involves monitoring and controlling critical process parameters that influence the critical quality attributes of the product. One of the prime processes in pharmaceutical solid dosage form is granulation and drying process. With the PAT and QbD initiatives, the FDA aims to increase efficiency of the pharmaceutical production by real-time process analysis and control. Near Infrared spectroscopy (NIRS) is well accepted as a potential PAT analyzer due to its rapid and nondestructive technique that additionally requires no sample preparation.
Metrohm is well-established in determining the moisture content by Karl Fischer titration in every conceivable type of product. To provide advance solutions for pharmaceutical customers, Metrohm now is moving forward, bringing NIRS to help customers to optimize the use of raw materials and to consistently run production closer to target specifications with time- and cost-saving analytical techniques.
During this webinar, we will be showing the use of NIR in the process that allows for monitoring low levels of residual moisture and other process constituents to yield better process control and endpoint determination. Additionally, we will be focusing on:
•Developing robust and precise method
•Minimizing implementation efforts
•Ensuring calibration model transferability between analyzers.
Doping control analysis predominantly utilises chromatography and mass spectrometry-based approaches to detect prohibited substances and methods of doping. These compounds and methods present both low and high molecular weight analytes of xenobiotic or natural / endogenous origin, which are to be detected, and occasionally quantified, using state-of-the-art instruments.
The majority of the employed tools provides low resolving power. However, high resolution / high accuracy mass spectrometry has gained much attention recently due to: constantly increasing analytical requirements concerning the number of target compounds; the complexity of analytes (e.g. peptides and proteins); and the desire to accelerate analyses and obtain information (allowing for retrospective data mining).
A selection of compounds, new challenges, and methods currently employed in doping control laboratories will be presented to the audience including, for example: new anabolic agents referred to as selective androgen receptor modulators (SARMs); insulins; so-called "releasing peptides" that stimulate the endogenous production of natural hormones; and ways of manipulating drug tests.
Technology overview and applicability to pharmaceutical quality systems.
A new family or Rapid Micro Method (RMM), real time viable particle detection based on Laser Induced Fluorescence (LIF), has recently been introduced. Sometimes referred to as optical spectroscopy, these instruments provide the ability to continuously measure for the presence of viable particles in real time. An overview of LIF technology will be presented along with a detailed look at TSI’s implementation in the BioTrak® Real Time Viable Particle Detector highlighting critical instrument performance parameters.
Several application scenarios will be reviewed in the context of current regulatory initiatives such as QbD, ICH Q8, Q9, Q10 and PAT. These applications can form a framework of increased knowledge resulting in a better understanding of the manufacturing process leading to improved product quality in addition to financial benefits.