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Rapid methods- The Next Phase : A Framework For Multi-Product Adoption...

Full Title: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing

The adoption of rapid sterility testing has significant benefits to the pharmaceutical industry; providing early notification of control drifts, a non-subjective answer to the sterility test and a faster time to product release.  However the challenges of adoption can be daunting.  By enhancing the benefits of regulatory interactions in the development phases, a complex post-approval regulatory change can be mitigated, however with limited material available, the outlined strategy provides a robust way forward to adopt rapid sterility and capture the benefits.

AstraZeneca considered the global operations of a major pharmaceutical company in the adoption of rapid sterility.  Utilising risk assessment tools and a holistic overview of pharmaceutical clean room flora, a representative panel of global microorganisms was selected.  Variability between product, consumables, organisms origin & status and testing sites was factored in. 

Focused studies were performed and data will be shared to provide an outline of the operating range that has been verified for the ATP Bioluminescence based sterility test.

The presentation will outline a vast & powerful data set which supports the robustness of the rapid sterility test, to enhance our product understanding.  Additional data was leveraged in time to result studies for “challenging organisms” such as slow growers.
Live online Jan 12 3:00 pm UTC
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Presented by
Miriam Guest, at AstraZeneca UK and Ulrich Herber at Charles River
Presentation preview: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption...
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    We will outline pragmatic strategies that may serve to reduce the risk of material supply chain shortages.  Such strategies are key to effective and efficient product commercialization.  This case study will illustrate the value of a practical risk-based approach towards managing raw material substitutions and outline key considerations in evaluating and executing raw material substitutions and second sourcing strategies.  A sample decision tree approach will be presented designed to enable right-sizing technical evaluation of raw material substitutions across both compendial and non-compendial raw materials.  The appropriate application of prior knowledge in this regard will also be discussed.
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    Building toward the commercial process: change control and managing product evolution for non-traditional development pathways, comparability challenges and clinical exposure
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    Finding the right partners – finding the right match in terms of not just technical ability, but also phase-appropriate GMP compliance and client service infrastructure; the impact of the Covid-19 pandemic on material and service providers
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    Full Title: An impurity detected in a stability study: Did we miss anything in our E&L risk assessment? Extractable and leachable (E&L) testing are required to identify substances that can or will migrate into the drug substance or drug product during the manufacturing process, storage and administration to assess the risk for patients being exposed to these substances. Stability testing is required to provide evidence on how the quality of a drug substance or product varies over time. E&L testing and stability testing can be run in parallel, but the conditions and detection techniques used for screening can be different. Although stability testing focuses on the quality of the drug substance or product by investigating the degradation products, it can occur that compounds are detected which are leachables. In this case study an unknown compound was detected during stability studies using LC-UV which could not be linked to a degradation product and was suspected to be a leachable. The question was raised if the unknown compound could be linked to extractables or leachables and if there was a potential risk for patient safety and drug product quality. E&L studies require complementary analytical techniques to screen for a wide range of compounds and the experimental design needs to be considered and stability studies can be set-up differently. This case study shows challenges in identification when using complementary techniques and discusses uncertainty in identification of leachables.
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    Bioprocessing 4.0 is a novel terminology that is typically identified as Industry 4.0 avatar in Bioprocessing. The overall concept of Bioprocessing 4.0 has been increasingly gaining traction and this trend is robustly projected to remain strong. Interestingly, even in business fora, the majority of discussions on Bioprocessing 4.0 are predominately technical. Emphasis is placed on the exposition of existing capabilities, and those under development, a situation reminiscent to marketing campaigns. Even when brought up, business arguments remain largely qualitative which, in turn, constitutes a conundrum given that Bioprocessing 4.0 is de facto an investment agenda. In this talk, we deviate from the technical land and re-examine Bioprocessing 4.0 through the lenses of an informed investor.  We show that optimizing Return on Investment requires the adoption of a holistic approach to Bioprocessing 4.0; an approach that simultaneously considers R&D and manufacturing.  However, the usual fences between R&D and manufacturing, a manifestation of siloing that plagues big corporations,  can jeopardize the overall business case. The main corollary of our analysis is that success predicates strongly on treating R&D and manufacturing as a continuum.
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    Full Title: Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products

    The need to utilize rapid sterility testing is gaining momentum within our industry, especially for short-life drugs with an immediate patient need, such as advanced therapy medicinal products (ATMPs; cell and gene therapies). This webinar will explore the challenges of manufacturing and releasing ATMPs and the benefits of implementing rapid sterility test strategies. In particular, we will discuss valorous global regulatory initiatives and policy changes that support the use of rapid sterility tests for these types of products, as well as the introduction of compendial chapters providing guidance for validation and implementation. We will finish with case studies on how rapid sterility validation studies may be performed.
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    Miriam Guest, at AstraZeneca UK and Ulrich Herber at Charles River
    Full Title: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing

    The adoption of rapid sterility testing has significant benefits to the pharmaceutical industry; providing early notification of control drifts, a non-subjective answer to the sterility test and a faster time to product release.  However the challenges of adoption can be daunting.  By enhancing the benefits of regulatory interactions in the development phases, a complex post-approval regulatory change can be mitigated, however with limited material available, the outlined strategy provides a robust way forward to adopt rapid sterility and capture the benefits.

    AstraZeneca considered the global operations of a major pharmaceutical company in the adoption of rapid sterility.  Utilising risk assessment tools and a holistic overview of pharmaceutical clean room flora, a representative panel of global microorganisms was selected.  Variability between product, consumables, organisms origin & status and testing sites was factored in. 

    Focused studies were performed and data will be shared to provide an outline of the operating range that has been verified for the ATP Bioluminescence based sterility test.

    The presentation will outline a vast & powerful data set which supports the robustness of the rapid sterility test, to enhance our product understanding.  Additional data was leveraged in time to result studies for “challenging organisms” such as slow growers.
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    Irving Ford at Bristol Myers Squibb and Lori Daane at bioMérieux
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    Marina Kirkitadze, at Sanofi Pasteur, Gabriella Gerzon, PhD at York University, and Dean Roberts Director at Bruker Corp
    Full Title: Near-infrared spectroscopy for monitoring Maillard reaction and critical process parameters of a C. tetani bioprocess
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    Lizbeth Martinez, Ph. D, at Novartis Basel Switzerland and Emiliano Genorini, at Viavi Solutions
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    Near-infrared spectroscopy (NIRS), as one of the major PAT tools, has attracted lot of attention from the pharmaceutical industry. NIRS can analyze samples without previous pretreatment, therefore reducing or eliminating wet chemistry analysis. During development of the drug product process, each unit operation brings challenges that need to be assessed in order to prevent compromising the quality of the final product. Two examples of real PAT applications are presented in this study. The first case tackles the challenges of process development in an international environment, with different locations for manufacture and traditional analytics. Showing how PAT enables a lean evaluation of the product quality, better understanding and supports process transfer. By means of in-line monitoring of the blending process, at-line content uniformity determination on high number of tablets and by helping the troubleshooting of segregation. The second case describes in-line monitoring by NIRS for assay determination in a wet met media milling process of a nano-suspension. NIRS proved to be a versatile and valuable tool for the pharmaceutical development and manufacturing of solid dosage forms.
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    Materials used in cell manufacturing may interfere with the test and therefore validation of bacterial endotoxin testing (BET) is mandated for each cell product. We’ll present the validation approach for endotoxin testing using Endosafe nexgen-PTS designed to meet Australian regulatory requirements.

    In this webinar, you will learn from our experts:

    Introduction to cartridge technology and its benefits
    How the Endosafe nexgen-PTS provides a rapid quantitative method for Endotoxin detection in CAR T-cell products.
    Why Maximum Valid Dilution (MVD) needs to be calculated and validated for each CAR T-cell product formulation and volume of infusion.
    Why it is important to perform interference testing using I/E cartridges and serial dilutions of the CAR T-cell product up to the MVD.
  • Advances in the Purification of Antisense Oligonucleotides Recorded: Oct 27 2021 61 mins
    Robert Gronke, Ph.D., Senior Principal Scientist, at Biogen and John Cyganowski, Director of Customer Application, Merck
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    Having completed process characterization for our lead ASO candidate, we have achieved a greater understanding of the process, its capabilities to clear process and product related impurities and understand the mechanisms that control the chromatography. On the manufacturing side, Biogen recently completed at scale PPQ validation batches of an ASO clinical candidate.  Cases studies and learnings will be presented on results from characterization studies and PPQ batches.
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  • Title: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption...
  • Live at: Jan 12 2022 3:00 pm
  • Presented by: Miriam Guest, at AstraZeneca UK and Ulrich Herber at Charles River
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