Microbiological testing is a critical component to ensuring the quality and safety of pharmaceutical products. In addition to robust manufacturing processes and controls, an appropriate QC testing strategy can provide assurance that products are free of contaminants and are suitable for their intended use. Compendial guidance (in some cases, harmonized across the USP, Ph. Eur., and JP) provides general instructions for testing based on validated methodology and long-established microbiological best practices. However, the application of appropriate methods and techniques depends on various product attributes and quality requirements. Understanding factors that contribute to method sensitivity and variability is important in generating consistent results and allowing meaningful data evaluation.
Join James Scull, Ph.D., Scientific Director for Element Life Sciences, for a live webinar to gain a deeper understanding of extractables and leachables (E&L) evaluations of custom drug delivery devices. Dr. Scull will present a case study that explores the E&L consideration of such custom delivery systems in order to meet regulatory requirements.
Why should I attend?
Dr. James Scull discusses extractables and leachables testing considerations for customized syringe delivery systems. His presentation will include:
Each phase of drug development encounters specific hurdles that require specialized expertise and advanced technologies to overcome and to ensure readiness for the next phase. A holistic approach to a program with cohesive program management can offer a dedicated focus to the intricacies of each phase and beyond. In this webinar, Catalent experts will explain how the phase appropriate expertise and technologies of the OneXpress™ Solution can help streamline development and manufacturing, speed up your program timelines, and reduce risks to transform your science into a successful treatment.
Inductively Coupled Plasma - Optical Emission Spectrometry (ICP-OES) and Inductively Coupled Plasma - Mass Spectrometry (ICP-MS) are widely applied in pharmaceutical analysis, including drug product analysis and medical device analysis. ICP-MS is commonly used for elemental impurities analysis and extractable/ leachable studies due to its high sensitivity. The evaluation of individual elements is based on USP 232 and ICH Q3D guidelines. Additional elements that are not included in the risk assessment per ICH Q3D can also be quantified. ICP-OES has been found to be a powerful tool in reverse engineering of a Reference Listed Drug (RLD). For those active pharmaceutical ingredients (APIs) containing metal elements, such as iron, zinc, arsenic, sodium, platinum, ICP-OES can be used to accurately quantitate these elements in the APIs and finished drug products.
Ke Wang, PhD
Senior Scientist I, Analytical Services of CMC Services - Frontage Laboratories
The classical approach to bioavailability enhancement of poorly water soluble drugs is through the use of solubility enhancers such as co-solvents, surfactants, and emulsifying agents. But depending on the rate limiting factors for drug absorption, simply increasing the API solubility may not have a significant impact on the bioavailability. There is an interplay between solubility and permeability that can be evaluated using In vitro flux/permeability testing. This can provide valuable insight into the potential factors limiting bioavailability, and should be characterized before choosing a bioavailability enhancing formulation approach. This approach can also be used to compare release and absorption of candidate formulations.
In this webinar we will discuss the use of in vitro flux and permeability as a tool in formulation development to:
Travis Webb, MS Pharmaceutical Chemistry
Formulation Scientist, CoreRx, Inc.
Are you wondering how to set up a stability test plan for your vial product? Are you confused at all the options for Container Closure Integrity Testing and wondering how to decide which one to choose for your product? Then join us for a webinar on Stability and CCI testing. We will outline the basics for setting up a stability test plan for rigid containers including aging conditions and testing frequency. We will look at how probabilistic methods differ from deterministic methods and will discuss each of the common CCI test options outlined in USP 1207. We will conclude with CCI method validation basics.
Jennifer Gygi, B.S., SM(NRCM)
Expert Technical Consultant, Nelson Labs