Thursday, April 8, 2021 / 1:00 PM EST
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
Tuesday, March 30, 2021 | 1:00 PM EST
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:
SPEAKER:
Travis Webb, MS Pharmaceutical Chemistry
Formulation Scientist, CoreRx, Inc.
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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.
Agenda:
Presenter:
Jennifer Gygi, B.S., SM(NRCM)
Expert Technical Consultant, Nelson Labs
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Univercells Technologies has been working to leverage deep expertise in bioprocessing and equipment development to revolutionize virus manufacturing for gene therapy and vaccine production. By combining the principles of intensification and chaining, the company has introduced the NevoLine™ Upstream platform, a fully automated and integrated biomanufacturing unit designed to enable commercial scale capacity in a compact module.
Directly from its development site in Belgium, Univercells Technologies is inviting you to join the virtual product launch of this breakthrough technology. The event will highlight the features of the NevoLine Upstream platform, including an explanation of the main benefits and key performance data. Attendees will see how users of the NevoLine Upstream platform can increase viral productivity while benefiting from a flexible process approach in a reduced footprint.
The event will offer:
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Learning Objectives
Who is it for:
Speaker:
Ben Wylie
Senior Product Manager, ChargePoint Technology
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Are you developing a biologic, biosimilar, or other complex drug product requiring lyophilization? Register for this webinar from Lubrizol Life Science to explore key considerations in designing and executing aseptic process simulations for lyophilized products, including a deep dive into study design, operational considerations, and regulatory guidance. Learn how robust validation can lead to commercial manufacturing success.
Key Learning Objectives:
Speakers:
Dr. Karen Bossert
Vice President of Operations, Lubrizol Life Science Health – CDMO Division
Judy Cohen
Vice President, Quality Assurance, Lubrizol Life Science Health – CDMO Division
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Piramal Pharma Solutions will present data from a simple OFAT experiment varying TCEP:mAb ratio to highlight the variability in distribution of species in some key assays supporting critical quality attributes of an Antibody Drug Conjugate. Piramal will discuss how this experiment can support product and process knowledge during product development (both early and late phase). We will aim to show how a small number of experiments can generate a large amount of data that is valuable to clients at key points during product development.
Speaker:
Allan Davidson
Head of Department, Analytical Development, Piramal Pharma Solutions
Expediting development timeline is directly related to obtaining IND clearance and starting phase 1 study faster. This webinar describes how you can get to IND faster through our accelerated & high performance proprietary cell line, S-CHOice; Samsung Biologics presents 3-month cell line development timeline and high-quality cell line. In addition, we will present the combined benefit with S-CHOice and 2-step purification platform, which can further expedite the timeline as well as reduction in manufacturing costs. We hope to share how our Faster & Better approach can be applicable to your molecule's successful development path to IND.
Speakers:
John Gill
Director of Cell Line Development
Beomkyu Kim
Lead Scientist of Downstream Process Development