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High-Resolution Characterization of Structure, Interaction, and Miscibility

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.
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Eric Munson, Professor and Head at Purdue University
Presentation preview: High-Resolution Characterization of Structure, Interaction, and Miscibility
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  • Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell Apr 2 2020 2:00 pm UTC 90 mins
    Dan Hill, Manufacturing Scientist at Biogen
    Full Title:Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell Culture Processes

    Presented by Dan Hill, Manufacturing Scientist at Biogen

    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.
  • Control Strategy and a Real Time Release Testing From a Development Line to... Mar 25 2020 9:00 am UTC 90 mins
    Tom Van Den Kerkhof Scientist at Johnson & Johnson
    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
  • Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materi Mar 23 2020 2:00 pm UTC 75 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.
  • Implementation Of An Affordable & Scalable Manufacturing Strategy Mar 18 2020 2:00 pm UTC 75 mins
    Bastiaan Leewis of MeiraGTx and Ankita Desai of Eppendorf
    Full Title: Implementation Of An Affordable And Scalable Manufacturing Strategy For Gene Therapy Products
    Presented by Bastiaan Leewis, MSAT Manager of Industrialization at MeiraGTx

    As a start up with multiple clinical programs within an accelerated track we started designing our processes and aimed to build facilities to ensure therapeutic drug products reach patients as quickly as possible. As scientists and as people this tends to be the main goal, and although there are many challenges to commercializing a therapeutic drug product this is only the first step. To be able to continually serve patients, the company must be set up in a way to be sustainable throughout the clinical phase until revenue can be generated via commercial sales. Understanding the patient and company needs are a key cornerstone for having successful products and a successful company transition from clinical to commercial products. Within this presentation I will illustrate and explain the approach chosen by MeiraGTx for some of the platform components.

    Followed by Bioprocess solutions for upstream bioprocess development and scale-up
    Presented by Ankita Desai, Bioprocess Field Application Specialist at Eppendorf

    Upstream bioprocess development is an integral part of gene therapy product development. Cell culture bioprocess development is usually carried out at small working volumes. This helps save time and resources, because several experiments can be conducted in parallel, costs for media are kept low, and relatively little laboratory space is required. When more material is needed for characterization, trial runs, and finally for commercialization, biopharmaceutical companies transition the process to bench scale and then up to pilot or production scale. In this presentation, we will present bioprocess solutions for parallel process development at small scale. Furthermore, we will discuss bioreactor scalability and address several scaling approaches.
  • IIoT and AI for Digitalizing Pharmaceutical Manufacturing Operations: From.... Mar 17 2020 2:00 pm UTC 90 mins
    Jun Huang, Director/Team Leader, Automation&Control at Pfizer and Amos Dor, Pharma General Manager & CTO at Applied Materials
    Full Title: IIoT and AI for Digitalizing Pharmaceutical Manufacturing Operations: From Hype to Reality
    Presented by Jun Huang, Director/Team Leader, Process Monitoring, Automation & Control at Pfizer

    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
  • The Journey Of Implementing Advanced Process Control In the Pharmaceutical... Mar 16 2020 2:00 pm UTC 90 mins
    Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen Pharmaceuticals
    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

    The presentation shares 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. Improving these metrics require a comprehensive technology strategy that addresses all the metrics together. Janssen’ s strategy 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 but in aggregate make it possible to reach our goals.

    APC is a critical component of the technology strategy. It is an enabler for process intensification and modular and flexible designs. As a stand-alone tool APC can bring significant reductions in deviations and impact right first-time performance. Additionally, it is possible to improve cost and cycle time modestly in exciting processes. We will highlight areas where APC is being used in open loop control. In these applications there is much value to a manufacturing organization in enabling smoother operations and helping operators making sense of complex data.
  • Mitigating Uncertain Times: Challenges with Rapid Detection and Characterization Mar 13 2020 2:00 pm UTC 90 mins
    Douglas E. Kiehl, Research Advisor, Bioproduct, Research & Development at Eli Lily and Company
    Full Title: Mitigating Uncertain Times: Challenges with Rapid Detection and Characterization of Biological and Chemical Threats and Accelerated Development of Pharmaceutical Countermeasures for Unanticipated Medical Needs

    Presented by Douglas E. Kiehl, Research Advisor, Bioproduct, Research & Development at Eli Lily and Company

    Potentially catastrophic chemical and biological threats represent deliberate or unintentional actions placing civilian and military personnel at considerable risk. Rapid response requires novel approaches for detection and characterization of chemical and pathogenic biological impurities and effective deployment of life-saving countermeasures with acceptable benefit/risk ratio. Challenges include the development of robust, portable technologies for rapid and reliable threat identification, processes for development, manufacture, review/approval and deployment of countermeasures, and supply chain integrity.
  • Antisense Oligonucleotide Purification Process: Successes and Challenges During Mar 10 2020 2:00 pm UTC 90 mins
    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

    Recently, our first full scale GMP batch for an antisense oligonucleotide was manufactured in the newly built synthesis suite at Biogen. A four-step purification process was then carried out in the existing flexible volume manufacturing facility that, up until this point, has been used for manufacturing Biogen’s protein-based parenterals. This was our first test case to demonstrate that Biogen can manufacture ASOs safely, at scale, and achieve high purity and yield. Results are presented on the scalability of the ASO process from bench to GMP scale, highlighting successes and challenges faced with scale-up of the downstream ASO process.

    Followed by an industry perspective presented by Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon
  • In Situ High Speed NIR Imaging to Monitor Form Change and Drug Release from... Mar 10 2020 10:00 am UTC 90 mins
    Patrick Wray, Senior Research Investigator at Bristol-Myers Squibb
    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.
    A custom designed flow through cell is used to carry out the tablet dissolutions in such a way that the sample is presented to the optics of the chemical imaging system being used. The cell is compatible for use with NIR, Raman and Mid IR spectrometers.
    Two types or formulations will be presented: Rapidly disintegrating formulations with varying amounts of super disintegrant and tablets containing a model drug exhibiting fast onset of disproportionation in pH neutral conditions.
    The fast NIR imaging system is seen to be capable of monitoring ingress of water into the tablet and the subsequent disintegration of the formulation. Data from the disproportionating formulations has shown the benefit of chemical imaging to improve our understanding of form change in real time.
  • Harnessing the Power of Data Analytics to Derive Process Intelligence for Pharma Mar 5 2020 8:00 am UTC 90 mins
    Santosh Whatkar, Senior Manager, Automation and Digital Technology at Pfizer
    Full Title: Harnessing the Power of Data Analytics to Derive Process Intelligence for Pharma Manufacturing

    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
    • Model based predictive ability of failure for automated valves
    • Virtual sensors for energy monitoring in manufacturing environment

    Case Study:  

    • Process condition monitoring using Machine Learning
  • Real-time Sequencing by FTIR in GMP Oligonucleotide Synthesis Mar 4 2020 3:00 pm UTC 90 mins
    John-David McElderry, Scientist at Biogen
    Presented by John-David McElderry, Scientist at Biogen

    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 Mar 3 2020 2:00 pm UTC 90 mins
    Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI
    Presented by Anders Sparén, Associate Principal Scientist at AstraZeneca

    The use of process analytical technology (PAT) in the pharmaceutical industry has significantly increased as an effect of regulatory guidelines and the transition towards continuous manufacturing of oral solid dosage forms. In the direct compression process, the most common way to assess homogeneity of powder blends is after the final mixing operation, followed by end-point testing of tablets. However, focusing on the homogeneity of powder blends does not consider the potential of segregation during material storage and powder transport and also faces severe sampling issues.

    In this study, NIR 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 order to improve the quality of the NIR measurements. These were made in laboratory settings that simulated in-line measurements in a vertical tube between the two blenders and in the feed frame of the tablet press. A model formulation consisting of powder mixtures of a drug substance, mannitol, microcrystalline cellulose (MCC), croscarmellose sodium (NaCMC) and sodium stearyl fumarate (NaSF) was used for the experiments. A design of experiments, where the API was varied at five levels while MCC, NaCMC and NaSF were varied at two levels, was used for the calibration powder blends.

    Orthogonal partial least squares (OPLS) calibration models for the NIR measurements in the two positions were developed and validated with independent test sets. The results for the sampling devices tested are compared and the future implementation in the continuous manufacturing equipment is discussed.

    Followed by an Industry Perspective Presented by Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI Solutions
  • MES-Integrating Technology, Quality and Compliance – Opportunities, Challenges Feb 18 2020 9:30 am UTC 90 mins
    Sachin Bhandari, GM, Head IT CSV at Sun Pharma
    Full Title: MES –Integrating Technology, Quality and Compliance – Opportunities, Challenges and Strategies.

    Defining the role of MES in using technology to achieve compliance.
    Addressing challenges in implementation of MES in current scenario with focus on Indian companies.
    Technology taking the compliance and quality framework to the next level.
    Organizational strategies to leverage the Power of technology by implementing MES.
  • High-Resolution Characterization of Structure, Interaction, and Miscibility Feb 11 2020 3:00 pm UTC 90 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.
  • mAb Industry in China: Biosimilars vs. Innovative Biologics Feb 10 2020 8:00 am UTC 90 mins
    Dr Joe X Zhou CEO Walvax Bio Group & Sarah Wang Head of Segment Marketing Biosimilars and Bioconjugations at Sarotrius China
    Presented by Dr Joe X Zhou, CEO at Genor Biopharma, Walvax Bio Group

    Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
     
    1.        Landscape changes of mAb therapeutics
    2.        New targets and process/manufacturing innovation
    3.        Key consideration of mAb industry in China
    4.        Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market

    Followed by Biosimilar development—how to deal with the similarity challenge

    Presented by Sarah (Xuyu) Wang, Head of Segment Marketing, Biosimilars and Bioconjugations at Sartorius Stedim Biotech

    Globally we have more than 1000 biosimilars in the pipeline till the beginning of 2019, Sales of mAb biosimilars is also taking up as popular targets being approved both in Europe and US. With the 3rd wave of the biosimilar coming the challenges is still ahead---how to keep the similarity from the beginning of the development to the manufacturing stage and cover the whole lifecycle? With the evolving cell line development platform, good analytical strategy and QbD implementation better similarity will be achieved step by step.
  • Identification of Approaches to Simulated Leachable Studies: What are They? W... Feb 3 2020 3:00 pm UTC 90 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... Jan 30 2020 3:00 pm UTC 90 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 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.
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  • Title: High-Resolution Characterization of Structure, Interaction, and Miscibility
  • Live at: Feb 11 2020 3:00 pm
  • Presented by: Eric Munson, Professor and Head at Purdue University
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