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Characterization of Subvisible Particles in Protein and Viral Vaccines

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur

The topic of this presentation is characterisation of visible and subvisible particles in protein and viral vaccine formulations. Visible and subvisible particles were found to be inherent to the product, and were analyzed by several methods including MFI, DLS and PALS.

Followed by Characterizing Sub-Visible Particle Populations with Micro-Flow Imaging

Presented by Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple

Accurate determination of sub-visible particles and protein aggregates is important to ensure safety and efficacy of biopharmaceutical formulations. As such, biopharmaceutical manufacturers are expected to characterize, monitor, and control sub-visible particles and protein aggregates in their products. Traditional techniques such as light obscuration often lack the sensitivity to distinguish translucent and potentially harmful protein aggregates. With imaging-based, direct particle detection, Micro-Flow Imaging (MFI) offers several advantages over traditional techniques, enabling the ability to detect and identify protein aggregates as well as other sub-visible contaminants. In this presentation, we will discuss how MFI provides particle count, size, and other morphological information in order to provide novel and unique insights into particle characterization and quantification in protein formulations.
Recorded May 21 2019 53 mins
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Presented by
Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein Simple
Presentation preview: Characterization of Subvisible Particles in Protein and Viral Vaccines
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  • The Journey to Lean Implementation for Efficiency Increase Sep 4 2019 9:00 am UTC 75 mins
    Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche
    Adoption of strategic and systematic use of lean principles to improve operational efficiencies and cost competitiveness
    Systematic reduction of waste, complexity and variability,
    Reduction of order lead time,
    Higher employee satisfaction and engagement tackling the cultural challenges
    Achieving speed and reliability in the manufacturing value chain.

    Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche

    Uwe Voelker is currently the Site Head (GM) at Roche in Mannheim, leading Pharma Operations (Biologics DP site). He was previously in VP-roles in both Quality and Techn. Operations, local and global roles, a.o. Head of Global Quality Small Molecules, Site Head in a Biologics DP site in Switzerland.
    Uwe is well versed in all aspects of Quality Management; Lean, Operational Excellence and Change management.
  • Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Proce Sep 2 2019 8:00 am UTC 75 mins
    Moritz von Stosch of GlaxoSmithKline Vaccines Followed by Klaus Mauch and Shilpa Nargund of Insilico Biotechnology AG
    Title: Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Process Development

    Knowledge from first principles is freely available and generally valid, and when integrated along with Artificial Intelligence (data-driven) methods, it can greatly improve the understanding and applicability. The applications of such an approach, referred to as hybrid modelling, to a fermentation and controlled drug release case are presented and the learnings from the development of these models are shared.
  • Mixed mode Chromatography in Purifying biologics - Overview Aug 20 2019 5:30 am UTC 41 mins
    Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, India
    This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proåteins. My discussion is intended for audience from biopharmaceutical industry as well as active collaborators from academic institutes.
  • Mapping Future Technology Needs For Real Time Release Testing Aug 9 2019 2:00 pm UTC 75 mins
    Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb
    Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.

    Presented by.
    Dr. Udayanath Aich is an Associate Director at Bristol-Myers Squibb. He previously was a Principal Scientist at Sanofi-Genzyme. He has extensive experience and management skills in analytical chemistry, high throughput technologies and process analytical technologies (PAT). Dr. Aich completed his Ph.D. from Indian Institute of Technology Madras in the area of Chemical Biology. After completion Ph.D., he has joined in Biomedical Engineering Dept of Johns Hopkins for his postdoctoral study in the field of cell engineering, glycoengineering and structure-activity relationship. Subsequently, he has decided to move to Massachusetts Institute of Technology to gain extensive skills in the area of Biopharmaceutical characterization and drug development. In 2011, Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Before Sanofi-Genzyme, Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics and structure-function study.
  • Lifecycle management of single use technologies Aug 5 2019 12:00 pm UTC 75 mins
    Francis Verhoeye, Director Single Use Technologies, GSK Vaccines
    Single-use technologies (SUTs) are one of the key drivers in the biopharmaceutical industry today and are changing the way we are operating and qualifying our bioprocesses, offering more flexibility and increasing efficiency. However, the extended use of those technologies in commercial operations requires a robust and specific lifecycle management approach. In this context, we have built an improved technical lifecycle management approach involving close partnership with key suppliers, enhanced standardization, early involvement of global manufacturing functions and full compliance with item creation process in order to ensure business continuity and value creation.
  • Designing production facilities of the future Jul 30 2019 2:00 pm UTC 75 mins
    Geoffry Hodge, Chief Technical Officer at Unum Therapeutics and Gary Pigeau, Ph.D., Director at GE Healthcare
    How can facilities be produced to meet the potential demand of cell and viral vectors
    What needs to change and what innovations are being made

    Presented by Geoffry Hodge, Chief Technical Officer at Unum Therapeutic

    Geoff is responsible for leading the development and execution of Unum’s CMC and technical operations, including process and analytical development, manufacturing, and quality, for the company’s proprietary antibody-coupled T-cell receptor (ACTR) therapies. He has over 25 years of experience in the biotechnology industry, providing bioprocessing technical solutions for companies including Millennium Pharmaceuticals, Genetics Institute (Wyeth), and Alpha-Beta Technology. Prior to joining Unum, Geoff was a co-founder of Xcellerex, inventor on several of Xcellerex’s foundational single-use technology patents, and an operations leader at Xcellerex. He holds an M.S. from WPI and bachelor’s degree from Colgate.

    Followed by Gary M. Pigeau, Ph.D., Director – Centre for Advanced Therapeutic Cell Technologies at GE Healthcare

    Gary Pigeau received his Ph.D. in Biotechnology from Brock University in St. Catharines, Ontario. He completed a postdoctoral fellowship at the University of Alberta with a visiting scientist appointment at the University of Oxford. Gary moved to private industry in 2008, where his research group focused on process development and scale-up of a proprietary bioprocess technology. He then moved to commercial, large-scale biomanufacturing in 2013. Gary joined GE Healthcare and the Centre for Advanced Therapeutic Cell Technologies (CATCT) @ CCRM in 2016 and led the pluripotent stem cell process development, scale-up and manufacturing efforts. Today, Gary is the GEHC Director of the CATCT delivering on customer-focused fee for service process, media and assay development projects, development of new products for GE Healthcare and internal technology development projects to continue to develop and grow capabilities within the group.
  • Use of Computational Modelling in Specification Setting and Establishing Control Jul 15 2019 2:00 pm UTC 75 mins
    Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE Ltd
    Full Title: Use of Computational Modelling in Specification Setting and Establishing Control Strategy

    The proportion of scientific evidence supporting medical product regulatory applications derived from modeling and simulation studies is expected to continue to grow into the future. In the Quality by Design framework, mathematical models can and have be utilized at every stage of product development and manufacturing. Thus, the regulatory assessment of product quality models is not unprecedented but the frequency, types of models, and applications are evolving. This evolution is being driven in part by the adoption of advanced manufacturing such continuous pharmaceutical manufacturing.
    The ICH Quality Implementation Working Group points to consider document categorizes models based on the model’s contribution in assuring the quality of the product. Models utilized as part of the control strategy are typically categorized as either high or medium impact depending on the role of the model. Minimal guidance though is provided on model validation. A recent standard (ASME V&V 40) outlines a process for making risk-informed determinations as to whether a model is credible for decision-making for a specified context of use. The presentation will discuss how the framework could be used to develop model validation plans and support regulatory assessment using case studies from both drug substance and drug product manufacturing.
  • Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies Jul 1 2019 2:00 pm UTC 75 mins
    John Wasylyk, Sr Principal Scientist at BMS and Karen Esmonde-White, Senior Marcom Specialist at Kaiser Optical Systems Inc
    During the lengthy process of pharmaceutical development, an Active Pharmaceutical Ingredient (API) or its intermediates can go through many physical and chemical changes. These changes are needed to produce the API with the correct chemical structure and physical property. Monitoring the progress of these transformations is important for the process understanding as well as serving as a tool for in-process control (IPC) to ensure the completeness of the transformation. IR and Raman Spectroscopies are sensitive to both chemical and physical changes of a compound and have evolved into useful tools in our lab for monitoring both chemical and physical transformations. They can be used to monitor the progress of the chemical reaction leading to the desired product, the slurry-to-slurry form transformation leading to the desired crystalline form, and the instability of API leading to undesired degradant. When used in-line, they can also be used to study the kinetics of a chemical reaction as well as the rate of crystalline form conversion...

    Followed by Utility of Raman spectroscopy in continuous processing of liquids and solids

    An important consideration in successful continuous manufacturing is integrating analytical tools into the flow. In batch reaction monitoring, on-line and at-line analyses enable Quality by Design (QbD) and ensure stable operations. Intense reaction conditions, non-traditional chemistries, high throughput and speeds, and miniaturized reactors are challenging environments for analytical tools originally developed for batch reaction monitoring. We present process Raman technologies adapted for continuous manufacturing processes in liquids and solids. Over the last 20 years, Raman spectroscopy has become an established technique for process monitoring and control, with applications in continuous manufacturing of liquids and solids...
  • Innovation in Biomanufacturing Plants Recorded: Jun 20 2019 72 mins
    Chris Chen PhD, CEO of WuXi Biologics and Dr. Sébastien Ribault, Senior Director for Global Delivery and Sales at Merck
    Biopharmaceutical plants will look different in the future. Agility and flexibility for rapidly changing product portfolios, single-use technologies, continuous manufacturing, small batch manufacturing, personalised medicine manufacturing will not only change the face of a plant but will also require other logistics models. Chris will explain WuXi Biologics' approach to biological facilities of the future.
  • Pharmaceutical Forensics for Safe Manufacturing and Supply Recorded: Jun 14 2019 77 mins
    Ravi Kalyanaraman and Jeremy Peters of BMS and Robert Heintz of Thermo Fisher Scientific
    by Ravi Kalyanaraman, Director at BMS

    Pharmaceutical Investigations and Technology (PIT) is a group within Global Analytical Technology (GAT) department in the commercial Quality organization within Bristol-Myers Squibb. The PIT group has been a key part in BMS for 30 + years in providing analytical support for commercial manufacturing and in pharmaceutical forensics. This include particulate and foreign matter characterization in pharmaceutical products and screening counterfeit drugs. Several analytical tools and techniques are used by PIT to support the pharmaceutical forensics.This talk will feature all the analytical techniques used by PIT and how the results are used in resolving manufacturing issues and to protect patients from counterfeit drugs.

    Followed by Why Use Raman Microscopy for Pharmaceutical Forensics?
    by Dr. Robert Heintz, Senior Applications Specialist at Thermo Fisher Scientific

    Raman microscopy is uniquely suited for providing essential information for pharmaceutical forensic applications. The use of visible lasers allows for analysis of very small samples with spatial resolutions down to a micron or better. Materials can be analyzed in glass containers and through transparent packaging. Mapping and imaging provides information on the spatial distribution of components as well as particle sizes and shapes. Confocal operation allows for probing inside transparent materials and analyze different layers or inclusions without the need to cut or cross-section the sample. Raman microscopy is non-destructive and preserves the sample for further analysis. Raman spectra can be used not only for the conformation of expected components but also the identification of unknown contaminants or impurities. Spectral features are very sensitive to molecular structure and can be used to distinguish polymorphs and other very chemically similar materials. All of these aspects of Raman microscopy make it an indispensable tool for pharmaceutical forensics.
  • HME lipidic Pellets for Paediatric Application. An Investigation of the Effect a Recorded: Jun 11 2019 43 mins
    Dennis Douroumis, Professor in Pharmaceutical Technology and Process Engineering at University of Greenwich
    Hot Melt Extrusion (HME) is an established processing technology that can be used for the development of paediatric formulations. The processing of lipids via HME has been proved ideal for high drug loaded dosage forms with sustained release of drugs. The study investigates the effect of the lipid type and the food grade on the dissolution rates of extruded pellets or extemporaneous formulations. The stability of lipidic formulations is a very important aspect especially for paediatric applications. Here the stability of various formulations comprising of GRAS excipients is also examined.
  • Innovative solutions from Industry 4.0 Recorded: Jun 10 2019 75 mins
    Michael May, President and CEO, CCRM at Centre For Commercialization Of Regenerative Medicine and Philip G. Vanek of GE
    -Potential to providing real-time visibility
    -Control across complex cell and gene therapy supply chains
    -QbD
    -How can industry 4.0 drive the industry towards increased industrialization?
  • New Drug Product Development Using Continuous Manufacturing Recorded: May 28 2019 74 mins
    Giustino Di Pretoro, of Johnson and Johnson and Dr. Robin Meier of L.B. Bohle Maschinen
    - What is Drug Product Continuous Manufacturing? 
    - Is Continuous Manufacturing really worth the effort? "without data, you are just another person with an opinion" 
    - What are the challenges implementing CM? 
    - Development and tech transfer considerations for CM.

    Learning Objectives:
    Demonstrate finacial and operational benefits of Continuous Manufacturing
    Explain the key challenges in the implementation of CM in R&D
    Explore key strategies in drug product development of CM
  • Viral Safety by Design for Cell and Gene Therapy Products Recorded: May 24 2019 68 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.
  • Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and C Recorded: May 23 2019 75 mins
    Dr. Michael J. Miller, President of Microbiology, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieux
    Full Title: Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products

    Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.
    This webinar will focus on recent regulatory policy changes, compendial recommendations and industry best practices for alternative approaches to sterility testing of gene and cell therapy products. A review of Ph. Eur. 2.6.27 (Microbiological Examination of Cell-Based Preparations), USP informational chapter (Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach), EU Guidelines on Good Manufacturing Practice Specific to ATMPs and FDA’s Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications will be provided.The information provided will be supported by case studies on selecting a relevant sterility test sample and an appropriate sample size for the release of gene and cell therapy products.
  • Characterization of Subvisible Particles in Protein and Viral Vaccines Recorded: May 21 2019 53 mins
    Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein Simple
    Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur

    The topic of this presentation is characterisation of visible and subvisible particles in protein and viral vaccine formulations. Visible and subvisible particles were found to be inherent to the product, and were analyzed by several methods including MFI, DLS and PALS.

    Followed by Characterizing Sub-Visible Particle Populations with Micro-Flow Imaging

    Presented by Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple

    Accurate determination of sub-visible particles and protein aggregates is important to ensure safety and efficacy of biopharmaceutical formulations. As such, biopharmaceutical manufacturers are expected to characterize, monitor, and control sub-visible particles and protein aggregates in their products. Traditional techniques such as light obscuration often lack the sensitivity to distinguish translucent and potentially harmful protein aggregates. With imaging-based, direct particle detection, Micro-Flow Imaging (MFI) offers several advantages over traditional techniques, enabling the ability to detect and identify protein aggregates as well as other sub-visible contaminants. In this presentation, we will discuss how MFI provides particle count, size, and other morphological information in order to provide novel and unique insights into particle characterization and quantification in protein formulations.
  • Do Extractable Protocols Truly Help- An End User Perspective Recorded: May 8 2019 48 mins
    Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for E & L at Merck KGaA, Darmstadt Germany
    Presented by Ekta Mahajan, Technical Regulatory Program Director at Genentech

    Extractables and their perceived impact on product and patients continue to be a challenge. The challenge is augmented by the lack of standardized extractable data from suppliers. BioPhorum Operations Group (BPOG) developed a standardized protocol for generating extractable data that would meet user requirements. This paper will discuss case studies where data from a supplier using the BPOG protocol significantly reduced the time for implementation.

    Followed by Standardized protocols for generating extractables data on Filtration and Single Use Systems – An analytical perspective

    Presented by Dr. Saskia Haehn, Laboratory Manager for E & L at Central Analytics of Merck KGaA, Darmstadt Germany

    The Biopharmaceutical industry has always been aware of the risk of using disposable technology such as filters and Single use systems in their processes despite their several unique advantages. The ability to control and mitigate the risk from extractables and leachables to a product and the patient safety highly depends on the availability of the complete extractables profile for these products. In the recent years, tremendous efforts have been made towards standardization of the Extractables test methodology both from the perspective of using the right extraction methods and the enhancement of analytical techniques. This discussion will focus on the challenges and advantages using the various model solvent streams in the standardized test methods and their relative comparison. In addition, the focus would also be on the unknowns arising from the analysis using such model solvent streams.
  • Pharmaceutical Hot Melt Extrusion A Cost Effective Method to Increase Solubility Recorded: May 7 2019 59 mins
    Dennis Douroumis, of University of Greenwich and Dr.-Ing Margarethe Richter, Pharma Application Specialist at Thermo Fisher
    Full Title: Employing Hot Melt Extrusion As a Cost Effective Method of Increasing Solubility Of Water Insoluble API’s
    • Identifying the appropriate excipients for HME processing of water insoluble drugs
    • Using novel excipients to achieve increased dissolution rates (Granulation)
    • Extrusion with polymeric carriers for the development of solid dispersions
    • Co-crystallisation of water insoluble drugs

    In the last 20 years Hot Melt Extrusion (HME) has seized the attention of pharmaceutical industry for the development of pharmaceutical solid dispersions. It is a versatile processing technology, which can effectively increase the solubility/dissolution of water insoluble active pharmaceutical ingredients (APIs). The processing of a wide range of materials including inorganic excipients, hydrophilic polymers or cocrystal formers renders HME advantageous compared to conventional formulation technologies. In this review article we discuss recent trends for increased solubility/dissolution of water insoluble actives by using HME and predictive tools for process optimisation.

    As a well-known process in polymer industry hot melt extrusion (HME) is approaching pharmaceutical manufacturing. HME allows innovative formulations of solid oral dosage forms. Its main advantage in pharmaceutical applications is the possibility to enhance bioavailability of a drug, i.e. to produce solid dispersions of the active pharmaceutical ingredient (API) in the polymer matrix. The main concern of the formulator is to achieve the appropriate release profile (immediate or sustained release) or improved bioavailability of the API. The presentation gives an introduction into HME technology as an alternative to spray drying. It includes several case studies related to HME for solid oral dosage forms. In addition to solid oral dosage forms hot melt extrusion (HME) can be used for novel delivery methods. The presentation gives an overview on possible applications including examples and case studies.
  • PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry Recorded: May 3 2019 71 mins
    Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Ro
    Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices commonly used for biologic formulations and certain therapeutic proteins. LER is defined as the inability to recover >50% activity over time when endotoxin is added to an undiluted product. LER is a temperature-and time dependent process, which usually does not occur immediately but after several hours to several days. Compendial LAL method qualification (Bacterial Endotoxin Test = BET per USP /EP 2.6.14/JP 4.01) does not include defined hold time conditions, which may explain why LER has not been detected by following compendial BET guidance. Because of the potential impact to patient safety and complex nature of the LER issue, the Parenteral Drug Association (PDA) published a Technical Report (TR) on LER. This TR was authored by subject matter experts from academia, U.S. FDA, biopharmaceutical companies, and reagent suppliers/testing contractors. The PDA Technical Report on Low Endotoxin Recovery provides a science-based and data-driven strategy in dealing with the LER phenomenon. The author of this article, who acted as co-lead of the TR authoring team, provides first hand information that allows companies to develop product specific solutions to the LER problem.
  • Analysing Complex Data in the Pharmaceutical Industry: The Case for Multivariate Recorded: May 2 2019 50 mins
    Mike Tobyn, Research Fellow at Bristol-Myers Squibb
    The Pharmaceutical Industry has a strong need to develop knowledge from data. Although the latter is not at a premium in the Pharmaceutical Industry the former is, as always, at a premium. Multivariate data analysis (MVA) is a set of statistical data analytical methods which has  been widely adopted within the Pharmaceutical Industry, and it has pre-eminence within the discipline.

    The ability of MVA to provide validatable solutions within a Regulated Pharmaceutical environment has arisen because of its transparency and reproducibility, across a wide field of data sources. An ecosystem of software providers, allied with hardware solutions, means that the  techniques are becoming widely understood and applied.

    Key to this adoption has been the ability of MVA techniques to meet not only direct Regulatory Guidance, but also Industry Standards such as ICH Q8 and initiatives such as Quality by Design.

    A wide body of literature is now available which explains how to use the technique appropriately, so that these Guidances can be met, leading to robust solutions
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  • Title: Characterization of Subvisible Particles in Protein and Viral Vaccines
  • Live at: May 21 2019 2:00 pm
  • Presented by: Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein Simple
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