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The Impact on Using Rapid Methods For Environmental Monitoring

EU Annex 1 is getting a tremendous makeover and significant revisions enabling the use of rapid methods and changing acceptance levels for environmental monitoring are forthcoming. In this webinar, Dr. Michael J. Miller will present an overview of regulatory and compendial policy changes that encourage the use of rapid methods for environmental monitoring, with a focus on the revision to Annex 1. This will be followed by an actual case study in the use of a real-time rapid method for the instantaneous and continuous detection of microorganisms in an isolator environment.
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Presented by
Dr. Michael J. Miller, President of Microbiology Consultants, LLC
Presentation preview: The Impact on Using Rapid Methods For Environmental Monitoring
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  • Monitoring Impurities in Biologics Aug 18 2020 4:30 am UTC 59 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.
  • Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder... Aug 11 2020 4:30 am UTC 73 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 Aug 10 2020 4:30 am UTC 59 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 Aug 7 2020 4:30 am UTC 80 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.
    Simulated leachable studies must be able to accurately simulate the expected leachables in a DP and should be carefully crafted to achieve this. The system used for extraction must have similar propensity to leach from materials under study a drug product and care must be taken not to use system which either leach too much (potentially masking other substance) or too little.
  • Identification of unknown extractables and leachables using mass spectrometry... Aug 6 2020 5:30 am UTC 57 mins
    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 Aug 5 2020 4:30 am UTC 83 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.
  • Rapid Microbiology Applications in the COVID-19 Era Aug 4 2020 2:00 pm UTC 120 mins
    Dr. Michael J. Miller, Ulrich Herber and Lori Daane
    The implementation of rapid microbiological methods (RMM) has gained significant momentum over the past few years. In particular, the ATMP segment has a desire to release cell and gene therapies using rapid sterility tests to accommodate patient needs and very short drug product shelf life. Additional rapid sterility testing needs are now being fueled by companies who are developing vaccines for COVID-19 clinical trials.

    In this webinar, Dr. Michael J. Miller will present an overview of past and future microbiological methods, the current regulatory landscape for rapid sterility testing including recent policy changes, applicable technologies and validation strategies.
  • Rapid Microbial Methods - Reap Benefits And Avoiding Pitfalls Jul 13 2020 2:00 pm UTC 90 mins
    Andrew Bartko, Research Leader at Battelle Memorial Institute
    An overview of the design, validation and implementation of RMM.
    Regulatory advice for RMM implementation
    3 key takeaways from a case study of RMM implementation
  • Challenges and Risks in Development and Manufacture of Covid 19 Vaccines Recorded: Jun 30 2020 121 mins
    Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC, North Potomac
    Coronavirus disease (COVID-19) is a terrifying illness with high morbidity and mortality throughout the world and with devastating effects on businesses, economies, livelihood of individuals and producing depression/fear among populations due to prolonged lock downs. The only way to control the disease appears to be by developing herd immunity, either by infection or by universal vaccination. Achieving herd immunity by infection seems horrific with a significant burden on healthcare systems and sacrificing vulnerable population, including older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer. Achieving herd immunity through vaccination will take at least several months to years after development of a safe and effective vaccine. Typically, it takes a decade or more to develop a vaccine. Scientists and vaccinologists from academia, industry and Government organizations are enthusiastically working on more than 100 vaccine candidates to develop a safe and effective vaccine. There are numerous scientific, technical, manufacturing, and regulatory challenges and risks in developing vaccines in general, particularly under a fast timeline. This Webinar will go over the challenges and risks in developing Coronavirus vaccines with a view to identifying these for resolution and mitigation along with development of the vaccines.

    Presented by Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC, North Potomac, USA

    Followed by:

    ROLE OF SERUM INSTITUTE OF INDIA LIMITED IN DEVELOPMENT AND MANUFACTURE OF COVID 19 VACCINE

    Presented by Harish Rao, General Manager at Serum Institute of India Ltd and Amar Shrivastava, Senior Manager at Serum Institute of India Ltd
  • Single-Use Bioprocess Platform for Veterinary Vaccine and Biopharmaceutical... Recorded: Jun 15 2020 77 mins
    Francis Verhoeye, Global Pilot Operations Leader at Zoetis Inc. and Benjamin Asher Senior Product Manager – Bioproduction
    Presented by Francis Verhoeye, Global Pilot Operations Leader at Zoetis Inc. and Benjamin Asher Senior Product Manager – Bioproduction

    •Understand the implementation journey taken to accelerate veterinary biological product development
    •Identify the challenges of integrating vaccine and biopharmaceutical processes
    •Learn about the single use qualification and implementation process in a multi-product facility
  • Final Revised Version of BioPhorum Extractable Testing Recommendation Part 2 Recorded: Jun 11 2020 123 mins
    Sara Ullsten R&D Section Manager, Cytiva and Haiyan Hong, R&D manager of Life Sciences at Saint-Gobain
    This Webinar is a continuation of Final Revised Version of BioPhorum Extractable Testing Recommendation Part 1

    Since the first publication of BioPhorum (previously known as BPOG) Extractable Testing Recommendation in 2014, the combined team of end-users and suppliers has collaborated to examine all improvement opportunities to the original Extractable Testing Recommendation since 2017. During this webinar, the presenters will highlight all the changes to the final revised version of BioPhorum Extractable Testing Recommendation. Specifically, the output of a data review of 26 extractable data sets spanning wide varieties of single use components, which has led to the changes to be made in the original recommendation, will be presented.

    The revised extractable testing recommendation will be presented to highlight:

    1) How to access the final version of the Biophorum Extractable Testing recommendation and example reporting template;

    2) “Data Sharing Rules of the Road” recommendations for simplifying access to the reports
    3 ) Where are the extractable data report flexibilities when using BEDS templates?

    To facilitate a harmonized extractable data reporting to end users, the presenters will introduce the newly designed BioPhorum Extractable Data Summary (BEDS) template. Some levels of details with regards to what specific information or format of templates are compulsory and what are flexible for supplier to tailor to their own preferences will be detailed during the webinar. How end users can gain access to these extractable summary reports from suppliers, including subsuppliers, will be addressed.

    Additionally, several FAQs questions will be presented to clarify some common questions. The webinars will end with 30 minutes of a panel discussion for participants to seek clarify of all presented information.
  • Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial... Recorded: Jun 3 2020 90 mins
    Dan Hill, Manufacturing Scientist at Biogen and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.
    The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past decade from a technology with promise to a standard tool for real-time, continuous monitoring of cell culture processes. There is an ever-growing body of work demonstrating successful application from metabolite and product quality monitoring to process control in both process development and GMP manufacturing environments. This is due, in part, to advances in technology robustness, user- and integration-interfaces, improved sensitivity, and fluorescence rejection. Organizations are now faced with the difficult task of best leveraging these tools and extracting the most value from them. Thus, defining and executing Raman program strategy is critical to the technology’s long-term success and sustainability.

    This presentation will describe Biogen’s past efforts and strategic direction as it relates to in-line Raman spectroscopy for cell culture operations and how we intend to leverage its capability beyond metabolite monitoring and glucose feedback control to become an essential element of our Advanced Process Control efforts.
  • Next Frontier in Subvisible Particle Analysis: New Tools and Opportunities Recorded: May 21 2020 100 mins
    Danny Chou, President and Founder at Compassion BioSolution, and Mark Mark Bumiller, Technology Manager at Entegris.
    Presented by Danny Chou, President and Founder at Compassion BioSolution, LLC
    Followed by an industry perspective presented by Mark Bumiller, Technology Manager at Entegris.

    In the past decade, we have witnessed the arrival of a large number of analytical technologies that are useful for characterizing sub-visible particles in protein therapeutics. Even with the diverse tools that are available today, there are still important gaps that have not been filled but yet have a significant role in our ability to fully analyze particles for either product characterization or formulation development purpose. The goal of this presentation is to highlight some of these gaps and share the opportunities that may be captured by new tools that are on the horizon. Finally, the speaker will elaborate on how simultaneous monitoring of sub-micron and micron-sized particles can assist biopharmaceutical formulation development and help fulfill current and future regulatory requirements.”
  • Continuous Manufacturing as a Default Platform for Oral Solid Drug Products Recorded: May 19 2020 99 mins
    Lawrence De Belder, Senior Principal Engineer at j&J and Bob Lenich, Director of Life Sciences Business at Emerson
    Presented by Lawrence De Belder, Senior Principal Engineer Continuous Manufacturing at Johnson and Johnson

    Followed by an Industry Perspective presented by Bob Lenich, Director of Life Sciences Business at Emerson

    The counter is at Six today: Orkambi, Symdeko, Trikafta (Vertex); Prezista (Johnson and Johnson); Verzenio (Eli Lilly); Daurismo (Pfizer) –are all approved by the FDA – Johnson and Johnson’s Tramacet for the Japanese market not included. Several large Pharma companies have chosen the path of Continuous Manufacturing, and announced they will use this platform as their default for development and consequently – commercial manufacturing of their Oral Solid dose drug product pipeline.

    During this webinar, the author will explain the consequences of this decision, and different strategies to handle a pipeline that can be highly dynamic. Different techniques will be discussed that can be used to bring products with bad flow properties into a continuous process. Impact of different equipment in development, clinical and commercial environment will be detailed out, and mitigations will be proposed to overcome these differences. All will be placed in front of a background of regulatory requirements, changing market demand, and evolving strategies of equipment vendors.
  • Final Revised Version of BioPhorum Extractable Testing Recommendation Part 1 Recorded: May 18 2020 104 mins
    Frances Sexton, Carsten Worsøe, Ken Wong, and Satish Kumar Mohanvelu
    Since the first publication of Biophorum (previously known as BPOG) Extractable Testing Recommendation in 2014, the combined team of end-users and suppliers has collaborated to examine all improvement opportunities to the original extractable testing recommendation since 2017. During this webinar, the presenters will highlight all the changes to the final revised version of Biophorum Extractable Testing Recommendation. Specifically, the output of a data review of 26 extractable data sets spanning wide varieties of single use components, which has led to the changes to be made in the original recommendation, will be presented.

    The revised extractable testing recommendation will be presented to highlight:

    1 End-users and suppliers collaboration set up;

    2 Specific updates to the extraction study recommendation;

    3 Specific areas of flexibility when implementing the protocol;

    4 Updates to the analytical test method system suitability;

    To facilitate a harmonized extractable data reporting to end users, the presenters will introduce the newly designed Biophorum Extractable Data Summary (BEDS) template. Some levels of details with regards to what specific information or format of templates are compulsory and what are flexible for supplier to tailor to their own preferences will be detailed during the webinar. How end users can gain access to these extractable summary reports from suppliers, including subsuppliers, will be addressed.

    Additionally, several FAQs questions will be presented to clarify some common questions. The webinars will end with 30 minutes of a panel discussion for participants to seek clarify of all presented information.
  • Assessing the Risk of Interaction Between Extractables and Leachable and Ther... Recorded: May 14 2020 94 mins
    Andrew Teasdale, Senior Principal Scientist at AstraZeneca and Piet Christieans, Phd,Scientific Director at Nelson Labs
    FULL TITLE: Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins

    Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca

    Biologics and Peptides often present their own challenges in respect to leachables. They are typically administered parenterally and therefore there is a high risk of interaction between dosage form and packaging / administration system. They are often low dose and sensitive to structural modifications, this can impact Safety (immunogenicity), Quality (instability, aggregation) and Efficacy (loss of potency). This webinar will examine the potential risk factors through case study examples including reactive leachables, the impact of sterilisation and adverse events and their route cause. It will conclude by looking at opportunities to look predictively at potential issues and how this can be incorporated into product design

    Followed by Piet Christieans, Phd,Scientific Director at Nelson Labs
  • Affinity Chromatography for Vaccines Purification Recorded: May 12 2020 46 mins
    Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines
    Presented by Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines

    Only clean drinking water rivals vaccination in its ability to save lives. Yet, development and manufacturing of vaccines remain challenging. Vaccines comprise a heterogeneous variety of targets. Each target requires a dedicated development and manufacturing process adding to the timelines for getting new vaccines to the patient and to ensure a reliable supply. For the downstream processing part, often the process is composed of an optimized set of up to three chromatographic steps to provide the final desired quality of the target. On top of the long development time required to develop such a multi-step process, at times, the end result may not be satisfactory, in particular regarding purity of the target.
    In order to overcome this downstream processing challenge, we embarked on establishing a purification platform based on affinity purification. The main advantages of such a platform for vaccine manufacturing would be:
    1)By applying a positive selection principle for chromatography, the number of chromatographic steps may be reduced to just one step
    2)Establishing a platform would require minimal process changes from one target to another
    3)Downstream processing would become predicable in terms of development time and costs
    The journey of establishing the affinity purification platform focusing on main challenges and key results will be presented in the Webinar.
  • Machine Learning in Bioprocess Development: Where We Are and Where We Could Go Recorded: May 6 2020 84 mins
    Rui Portela and Klaus Mauch, CEO at Insilico Biotechnology AG
    Machine Learning is believed to be a game changer for industry, especially by big Pharma as reflected by significant investments. Starting from an introduction to machine learning, this contribution outlines the current machine learning status for process development with examples, provides future directions towards more global high-value machine learning centric development, concepts to engage people in the digital evolution and ideas for machine learning centric business models.

    Presented by Rui Portela, Senior Data Scientist, GlaxoSmithKline Vaccines

    Rui Portela works as Senior Data Scientist at Global Data Analytics and Innovation group in Technical R&D of GSK Biologicals, Belgium. He is a molecular and cell biologist, with a MSc in biotechnology from the New University of Lisbon (UNL) and PhD in Bioengineering Systems (MIT-Portugal program – UNL). Previously, Rui worked on model based bioprocess optimization at GSK and IBET as research scientist, applying metabolic network analysis, PAT, simulation of molecular processes and hybrid modeling methods to enable more efficient process operation/design.

    And Klaus Mauch, CEO at Insilico Biotechnology AG

    Klaus Mauch is one of Insilico’s co-founders and became managing director in 2004 and CEO in 2006. In his previous role as CTO, he was responsible for the design and development of Insilico’s modelling and simulation platform where he established novel methods for the computer-aided construction of cellular networks. Before that, he gained extensive experience in metabolic engineering and applied systems biology as a group leader at the Institute of Biochemical Engineering, University of Stuttgart. Klaus is a member of the Advisory Board of the Division Systems Biology and Synthetic Biology of DECHEMA, board member of the Industrial Association White Biotechnology (IWBio), and board member of the Association of German Biotechnology Companies (VBU).
  • New Drying Processes for Biopharmaceuticals Recorded: May 5 2020 91 mins
    Sune Klint Andersenand Principal Scientist at Janssen Pharmaceutical and Lars Markwort, co-founder and CEO of Bioinicia SL
    Presented by Sune Klint Andersen, Principal Scientist at Janssen Pharmaceutical Companies of Johnson & Johnson

    Sune Klint Andersen is Principal Scientist for Spray Drying at the Janssen Pharmaceutical Companies of Johnson & Johnson. He has a Ph.D. in Chemical Engineering. He has worked with pharmaceutical spray drying for 17 years within process development for R&D and commercial scale, application of Quality-by-Design and PAT, particle engineering, drying kinetics, aseptic spray drying and advantages and disadvantages of spray vs freeze drying processes. He previously worked at Novo Nordisk for 7 years.

    and followed by Lars Markwort, co-founder and CEO of Bioinicia SL


    Lars Markwort is co-founder and CEO of Bioinicia SL. He holds a Ph.D. in Chemistry and worked for 20 years in the analytical and process equipment industry, supplying mainly the semiconductor and pharmaceutical industries. At Bioinicia he is guiding the scaling up of electrohydrodynamic processes to industrial production with a focus on drying, micronization and encapsulating of labile bioactives for applications in pharmaceuticals and nutraceuticals.
  • Transformation of Toxicology data into Specific PDE’s Recorded: Apr 23 2020 92 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.
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  • Title: The Impact on Using Rapid Methods For Environmental Monitoring
  • Live at: Sep 2 2020 2:00 pm
  • Presented by: Dr. Michael J. Miller, President of Microbiology Consultants, LLC
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