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Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Ble

Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Blend Homogeneity in Continuous Manufacturing

In continuous direct compression of pharmaceutical formulations, it is essential to assess the homogeneity of powder blends. This could preferably be done in situ, using fast spectroscopic techniques. In this study, near-infrared spectroscopy was used to study powder blend homogeneity at two positions in the continuous manufacturing process; after the first blender and in the tablet press feed-frame. The focus of the study was on sample presentation at the two positions, and several sampling devices were tested in a laboratory setting using a model formulation, aiming at improving the quality of the NIR measurements. The results for the sampling devices tested are compared and the future implementation in the continuous manufacturing equipment is discussed.


Followed by Powder Blend Homogeneity Monitoring with the Viavi MicroNIR PAT-W

The MicroNIR PAT-W wireless NIR spectrometer is used in monitoring blend uniformity in pharmaceutical manufacturing. The PAT-W is a rugged, IP65/67 rated instrument with no moving parts. The PAT-W, with >8 hours battery life, WiFi communication and onboard gravity sensor is well suited for use on tumble blenders in regulated facilities. Viavi’s Linear Variable Filter technology, optical fiber-free design and dual onboard tungsten lamps ensure excellent stability, long lifetime and minimal instrument-to-instrument variability. Viavi MicroNIR Pro software provides data acquisition and chemometric model building, and assures compliance with Title 21 CFR Part 11, USP chapter 1119 and EP chapter 2.2.40. OPC communication and control are also available for use in process environments.
Recorded Mar 3 2020 74 mins
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Presented by
Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI
Presentation preview: Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Ble
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  • Transformation of Toxicology data into Specific PDE’s Apr 23 2020 5:00 pm UTC 90 mins
    Kim Li, PhD, DABT, MPH, Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC
    Presented by Kim Li, PhD, DABT, MPH, Amgen Inc.

    Followed by an industry perspective presented by Dries Cardoen, Team Leader of Study Directors - Inhalation/topical/transdermal products at Nelson Laboratories, LLC

    Permitted Daily Exposure (PDE) has origin in ICH Q3C: Impurities – Guideline for Residual Solvents. This webinar will discuss the principles and methods of applying PDEs to extractactables and leachables (E&L) impurities in pharmaceutical products. We will review the regulatory advice on the DO’s and DON’Ts. Then we will review the current toxicology risk assessment practice on data gathering, literature synthesis and selection of the critical studies with robust toxicity endpoints. We will show how the toxicity endpoints are transformed into chemical-specific PDE values with modifying factors. We will highlight the importance of clinical relevance to further refine the PDE values. For a case study, we will share an extraction study of a polyolefin bag for use with a lyophilized product. We will examine the risk matrix per USP Assessment of drug product leachables associated with pharmaceutical packaging/delivery systems. The toxicology assessment of the extractables profile of the bag will illustrate the derivation of chemical-specific PDEs, as well as the refinement by taking clinical relevance into consideration.
  • New Technologies for Improving and Controlling Product Quality, Expression, Time Recorded: Apr 7 2020 39 mins
    Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte Ltd
    Full Title: New Technologies for Improving and Controlling Product Quality, Expression, Timelines and Yield in Upstream Process Development

    Presented by Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte Ltd

    Increasing product demands at competitive pricing drive the need for accelerated product approval timelines, with reduced manufacturing risks and costs. New technologies which can debottleneck upstream process development or improve manufacturability success in early phase process development, translate into cell culture processes with high yield and desired product quality. An overview of different strategies and recent perspectives in upstream process development will be presented.
  • Control Strategy and a Real Time Release Testing From a Development Line to... Recorded: Mar 25 2020 82 mins
    Tom Van Den Kerkhof Scientist at Johnson & Johnson and Sebastian Sowinski at Sentronic
    Full title: Control Strategy and a Real Time Release Testing From a Development Line to Commercial Manufacturing

    Presented by Tom Van Den Kerkhof Scientist at Johnson & Johnson
    Followed by Sebastian Sowinski, Key Account Manager in the Spectroscopy business unit at Sentronic in Dresden

    Johnson & Johnson has invested in three different continuous manufacturing lines, where PAT applications are applied to determine the uniformity of the final blend and the core tablets. Two CM lines have been implemented to accomplish the high-volume demand of two commercial products, while a third CM multi-purpose line, allowing to perform wet-granulation, roller compaction or direct compression, has been implemented in the R&D facility for the development of new drug products. In this presentation, the PAT control strategy currently applied for the commercial products as well as the one applied for new products is presented. Furthermore, the use of the generated PAT data to release the final batch is presented for a direct compression commercial product. For this commercial product, the PAT analysis performed on the core tablets by NIR spectroscopy are used to replace the final product testing in the laboratory for the release testing of assay, content uniformity and dissolution.
  • Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materi Recorded: Mar 23 2020 79 mins
    Ping Wang, Director at Johnson & Johnson and Donald DeCou, E&L Technology Manager at West Pharmaceutical Services
    Full Title: Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production
    Presented by Ping Wang, Director at Johnson & Johnson

    • Safety assessment of extractables and leachables is often based on assumption that E&L are highly toxic
    • Most common extractables from about 40 sets of study data indicates that none of them is part of “cohort of concern” per ICH M7 guideline.
    • Safety profiles of common extractables from common single use systems can be used to design a risk-based approach for future materials.

    Followed by Current Trends in Extractables and Leachables Testing from Manufacturing Equipment to Single Use Manufacturing Components
    Presented by Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services

    There are many types of components that a drug formulation may contact during a typical manufacturing process.  This can range from large volume mixing vessels to filters, tubing and other smaller components.  More recently the use of Single Use Systems (SUS) have been steadily increasing during the manufacture, handling and storage of biologics.  Each contact component has the potential to introduce leachable compounds to the drug formulation.  The BioPhorum Operations Group (BPOG) has developed standardized extractables testing protocol for SUS.  This talk will review some of the central concepts of the BPOG protocol as well as current trends in performing extractable, leachable and simulation studies on manufacturing components and single use systems.
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    Jun Huang, Director/Team Leader, Automation&Control at Pfizer and Amos Dor, Pharma General Manager & CTO at Applied Materials
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    Driven by increased connectivity enabled by Industrial Internet of Things (IIoT) and more sophisticated data gathering and analytics/AI capabilities, manufacturing is ushering in a new era of production, where information technology (IT) and operation technology (OT) are converging to form so-called cyber-physical systems. IIoT and analytics are key complementary driving forces behind digitalization, enabling a securely connected plant and a streamlined flow of data and information between physical production and digital worlds, as well as prescription of data-driven actions pervasively across manufacturing and quality operations. Use case examples will be given to demonstrate how IIoT and analytics are implemented in practice to drive continual improvement in manufacturing visibility, quality and productivity.

    Followed by an Industry Perspective Presented by Amos Dor, Pharma General Manager & CTO at Applied Materials Automation Product Group
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    Olav Lyngberg, Sr Scientific Fellow at Janssen Pharma and Mark Demesmaeker Head of Data Analytics at Sartorius Stedim Biotech
    Full Title: The Journey Of Implementing Advanced Process Control In the Pharmaceutical Industry
    Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen Pharmaceuticals and

    The presentation will share the journey that Janssen is taking as it progresses its strategy on Advanced Process Control (APC). Within Janssen we aspire to improve our Manufacturing Technology Organization’s performance on key metrics such as cost of goods, on time and in full product delivery, production cycle time, and right first-time process performance. Improving these metrics require a comprehensive technology strategy that can address not just one but all the key metrics together. The strategy that Janssen is pursuing has three pillars. 1: process intensification, 2: modular and flexible designs, and 3: process digitalization and advanced process control. Each pillar contributes differently to the key metrics and in aggregate and when achieved together they make it possible to reach all the goals.

    Followed by Obtaining Increased Observability & Control of the Bioprocess
    Presented by Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech

    As the biopharmaceutical industry is undergoing the digital transformation, a number of disruptive technology evolutions and market shifts are happening in parallel: Novel approaches in bioprocessing (e.g., intensified and continuous processing) are pushing cells and expression systems to their limits. New process analytical technologies are introduced, including online spectroscopy, advanced single-use sensors, and advanced modeling and simulations. Adding to that a trend towards increased miniaturization and throughput of cell culture processes puts an enormous burden on data streaming, management, and preparation. Recent progress in cellular and gene therapies also contributes to the evolution of bioprocessing.
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    Robert Gronke, Ph.D., Senior Principal Scientist, Biogen and Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon
    Full Title: Antisense Oligonucleotide Purification Process: Successes and Challenges During Scale-up

    Presented by Robert Gronke, Ph.D., Senior Principal Scientist, Technical Development, Biogen

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    Patrick Wray, Senior Research Investigator, BMS and Miriam Böhmler, Senior Applications Scientist at WITec GmbH
    Full Title: In Situ High Speed NIR Imaging to Monitor Form Change and Drug Release from Rapidly Disintegrating Tablets
    Presented by Patrick Wray, Senior Research Investigator at Bristol-Myers Squibb

    Spectroscopic imaging is a powerful chemically specific and spatially resolved approach which can be used to effectively monitor tablet dissolution. This work employs Raman mapping and Near Infrared (NIR) chemical imaging to examine drug release from model tablet formulations as complementary technologies. Modern pushbroom type NIR imaging systems allow extremely fast acquisition of chemical images. Consequently this allows us to study the chemical and physical changes which occur during drug release from rapidly disintegrating formulations.
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    Followed by Cutting-edge Raman Imaging for New Advances in Pharmaceutics
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  • Harnessing the Power of Data Analytics to Derive Process Intelligence for Pharma Recorded: Mar 5 2020 49 mins
    Santosh Whatkar, Senior Manager, Automation and Digital Technology at Pfizer
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    Presented by Santosh Whatkar, Senior Manager, Automation and Digital Technology at Pfizer

    At Pfizer Singapore, significance of Data Analytics was realized after a period of 1 and half years when we were able to successfully implement the pilot use cases enabling us with Digital capabilities.

    It would be a sharing with the audience about the Pfizer, Singapore journey of Digital Transformation and the various learnings along the way; which enabled several attributes from teamwork, persistence, believing the vision and doing things differently.  Data Analytics significance was realized after passing through this journey and we were enlightened with the amazing capabilities existing data can have. Although our problem statements existed for several years, the change in perspective of using Digital technologies and existing data enabled us to find robust solutions.

    Below case studies would elaborate more on the enhancing Pfizer’s manufacturing robustness  leveraging on Digital Transformation capabilities –

    Case Studies:

    • Model based real time estimation of loss of drying
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    Case Study:  

    • Process condition monitoring using Machine Learning
  • Real-time Sequencing by FTIR in GMP Oligonucleotide Synthesis Recorded: Mar 4 2020 83 mins
    John-David McElderry, Scientist at Biogen and Dominique Hebrault, Science & Technology Business Development at Mettler-Toledo
    Presented by John-David McElderry, Scientist at Biogen
    Followed by an Industry Perspective presented by Dominique Hebrault, Science & Technology Business Development at Mettler-Toledo International, Inc

    John-David McElderry graduated from University of Michigan with his PhD in 2012 and has been an analytical scientist and PAT expert in the Pharma/Biotech industry for seven years. He started his career at Vertex Pharmaceuticals creating PAT applications for the first continuous DP manufacturing rig and helped develop the first real-time release strategy in the industry. He is currently at Biogen where he has developed PAT-based control strategies for continuous flow chemistry of small-molecule drugs and continuous synthesis of oligonucleotide drugs. He is interested in enabling real-time control of quality attributes in pharmaceutical manufacturing through the application of smart sensors and machine learning.
  • Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Ble Recorded: Mar 3 2020 74 mins
    Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI
    Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Blend Homogeneity in Continuous Manufacturing

    In continuous direct compression of pharmaceutical formulations, it is essential to assess the homogeneity of powder blends. This could preferably be done in situ, using fast spectroscopic techniques. In this study, near-infrared spectroscopy was used to study powder blend homogeneity at two positions in the continuous manufacturing process; after the first blender and in the tablet press feed-frame. The focus of the study was on sample presentation at the two positions, and several sampling devices were tested in a laboratory setting using a model formulation, aiming at improving the quality of the NIR measurements. The results for the sampling devices tested are compared and the future implementation in the continuous manufacturing equipment is discussed.


    Followed by Powder Blend Homogeneity Monitoring with the Viavi MicroNIR PAT-W

    The MicroNIR PAT-W wireless NIR spectrometer is used in monitoring blend uniformity in pharmaceutical manufacturing. The PAT-W is a rugged, IP65/67 rated instrument with no moving parts. The PAT-W, with >8 hours battery life, WiFi communication and onboard gravity sensor is well suited for use on tumble blenders in regulated facilities. Viavi’s Linear Variable Filter technology, optical fiber-free design and dual onboard tungsten lamps ensure excellent stability, long lifetime and minimal instrument-to-instrument variability. Viavi MicroNIR Pro software provides data acquisition and chemometric model building, and assures compliance with Title 21 CFR Part 11, USP chapter 1119 and EP chapter 2.2.40. OPC communication and control are also available for use in process environments.
  • High-Resolution Characterization of Structure, Interaction, and Miscibility Recorded: Feb 11 2020 60 mins
    Eric Munson, Professor and Head at Purdue University
    Full Title: High-Resolution Characterization of Structure, Interaction, and Miscibility of Drug Products

    The local interactions between a drug and its surrounding environment is critical in both small and large molecule formulations. For small molecules, the drug-polymer interaction is needed to ensure that the drug does not crystallize in an amorphous solid dispersion. For proteins, phase separation in lyophilized formulations will lead to reduced stability and the potential for aggregation. In this presentation, the ability to probe these local structures and interactions in both small and large molecule systems will be shown. Case studies will be presented that demonstrate how structural properties (e.g. degrees of interaction, changes in conformation) can impact functional properties such as crystallization and aggregation.

    Eric Munson of Purdue University

    Eric Munson, Ph.D., is currently Professor and Head of the Department of Industrial and Physical Pharmacy at Purdue University. He received his B.A. degree from Augustana College in Sioux Falls, South Dakota, in 1987. After studying one year in Munich, Germany, on a Fulbright Fellowship, he received his Ph.D. in 1993 from Texas A&M University, and was a postdoctoral fellow at the University of California, Berkeley in 1994. He was in the Chemistry Department at the University of Minnesota before moving in 2001 to the Pharmaceutical Chemistry Department at the University of Kansas, to the Pharmaceutical Sciences Department at the University of Kentucky in 2010, where he was the Patrick DeLuca Endowed Professor in Pharmaceutical Technology. In 2018 he moved to Purdue University to become Professor and Head of the department. His research program is focused on the characterization of pharmaceutical solids using a variety of analytical techniques, with an emphasis on solid-state NMR spectroscopy. Dr. Munson is a coinventor on three patents and has published more than 100 research, review, and book chapters.
  • Identification of Approaches to Simulated Leachable Studies: What are They? W... Recorded: Feb 3 2020 81 mins
    Jason Creasey, Managing Director at Maven E&L and Karen Pieters, Ir. Team Leader E&L at Nelson Labs Europe
    Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

    Presented by Jason Creasey, Managing Director at Maven E&L Ltd. Followed by an Industry Perspective presentation presented by Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe

    The term “Simulated leachable studies” is open to interpretation. I hope to provide a definition of this term and in doing so suggest when they can and should be used. The general aim of such studies is to provide an accurate qualitative and quantitative description of the substances which might be present as leachables in a pharmaceutical drug product (DP) derived from container closure system (and sometimes its manufacturing process) when the drug product is stored up to and including its shelf-life. Simulated studies provide an alternative to analysis of leachables directly in the drug product. A simulated study aims to avoid some of the downfalls of leachable analysis such as; inaccurate analysis of leachables due to interference from drug product and/or formulation elements, availability of stored DP samples, reaching required limits of detection in the DP and time / resource constraints associated with complex method development using DP.
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    Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific
    Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?

    Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. Substances can be identified using mass spectral libraries to enable a toxicological risk assessment which considers the risk of patient exposure. However, how confident are we when we identify a substance using spectral libraries? A match with mass spectral libraries, data from orthogonal techniques, fragmentation data and availability of a certified reference standard can increase the level of confirmation. We will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables
  • Qualification of Raw Materials and Cell Substrates for Biomanufacturing Recorded: Jan 16 2020 84 mins
    Maura Kibbey Senior Scientific Fellow, Global Biologics at USP and Martin Wisher, Global Head of Regulatory Affairs at Merck
    Presented by Maura C. Kibbey, Ph.D., Senior Scientific Fellow, Global Biologics U.S. Pharmacopeia
    Followed by an Industry Perspective presented by Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck

    The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents. This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins.
  • Monitoring Impurities in Biologics Recorded: Nov 26 2019 60 mins
    Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia 
    The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: 1) product-related impurities, such as precursors, aggregates and degradation products, and 2) process-related impurities, such as host cell DNA, host cell protein, and particulates.  This presentation will provide an overview of approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.

    Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia 

    Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities Recorded: Nov 20 2019 64 mins
    Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS at Pall Biotech
    Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd

    Current trends and regulation affecting Biopharmaceutical Industry
    Journey from Lab scale to Commercial –Overcoming Scalability design hurdles
    QbD-Bringing Improvements in Biologics development and Manufacturing Space

    Followed by Quality by Design (QbD) Approach for a Virus Filtration Application
    Presented by Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech

    Removal of viruses in bioprocessing applications is a fundamental regulatory requirement, and the use of virus filtration is considered a robust and well accepted component of a virus clearance strategy. With the advent of the International Conference of Harmonization (ICH) Q8 Pharmaceutical Development and Q9 Quality Risk Management guidelines, there is much greater emphasis for filter users to define the filter design space, in addition to performing the mandatory virus filtration validation studies.
    A thorough understanding of the virus filtration design space not only alleviates the risk of viral contamination, but an in-depth understanding of the boundaries of the process parameters ensures the manufacturing process remains in control. In this webinar, we describe an approach to implement QbD principles into virus filtration to create a safe and robust biomanufacturing process.
  • Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum Recorded: Nov 15 2019 67 mins
    Saly Romero-Torres, PhD, of Biogen and David Lovett & John Mack of Perceptive Engineering
    Full Title: Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

    Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

    Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).

    Followed a Presentation by David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering
  • Just in Time Release of CAR T Cell Therapies Recorded: Nov 11 2019 77 mins
    Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
    Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene

    The views and opinions expressed during the Webinar are those of the presenter.

    Currently CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. As such manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release.
    Risk based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented eliminate the risk or to reduce the risk to an acceptable risk level.
    Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This Webinar will highlight microbial contamination control and testing strategies that can be employed throughout each stage of the manufacturing process that will allow for a potential just in time release of CAR T products.

    Followed by an Industry Perspective presented by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux

    Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology. She is a technical expert on Rapid and Alternative Methods and participates in the sourcing and evaluation of new technologies and potential partnerships in the field of microbial control. She provides scientific support to the Healthcare Business in North America and is responsible for managing feasibility testing and method development for bioMérieux instruments and culture media products.
  • Viral Safety by Design for Cell and Gene Therapy Products Recorded: Nov 11 2019 67 mins
    Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS
    Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C&GT) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C&GT product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.
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  • Title: Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Ble
  • Live at: Mar 3 2020 2:00 pm
  • Presented by: Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI
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