Webinars

    Contamination Control For Pharmaceutical Products

    Contamination Control For Pharmaceutical Products

    07.27.22

    Real-World Moist Heat Validation Pitfalls And Proper Verification Of Sterility

    Moist heat sterilization is a commonly used and widely accepted process in pharmaceutical processes. As such it is critical that it be carried out correctly. In this webinar we will address real-world observations relating to moist heat sterilization processes, discuss the science behind the observations and present solutions to result in a successful validation outcome.

     

    As a contamination control program is meant to result in microbiologically acceptable product, usually with a sterile claim, it is also critical to be capable of demonstrating sterility. Although demonstration or verification of sterility is commonly accomplished by performance of a test for sterility via USP<71>, that test only represents one slide in the complete movie of contamination control, thus a fuller perspective of verification of sterility must be considered and will be addressed.

     

    The format of the webinar will be an introduction to these two topics followed by a panel discussion to address your specific questions or challenges and updates in the industry.


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    Sensitivity Enhancement in Point of Care Diagnostics Using Gold Nanoshell Probes

    Sensitivity Enhancement in Point of Care Diagnostics Using Gold Nanoshell Probes

    07.21.22

    Nanoparticles are emerging as powerful tools for research, therapeutic, and diagnostic applications and their utility as lateral flow test probes has gained prominence in recent years. As the need for more sensitive tests increases, new types of nanoparticles are being investigated and incorporated into lateral flow assays.


    This webinar will highlight:
     

    • The advantages and disadvantages of some common covalent reporter probe types.
    • The unique properties of nanoComposix Gold Nanoshells and how they relate to lateral flow assays.
    • Examples of assays where sensitivity enhancement was achieved with gold nanoshells.
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    Benefits of MycoSEQ™ for Faster Mycoplasma Detection

    Benefits of MycoSEQ™ for Faster Mycoplasma Detection

    07.07.22

    Mycoplasma contamination can have devastating effects on the manufacture of cell and gene therapies, requiring the destruction of production batches and halting of manufacturing processes, and ultimately, in delayed provision of treatments to patients.

    Rapid and sensitive tests are necessary for lot release to ensure the absence of mycoplasma contamination. The compendial culture-based method, although highly sensitive, takes 28 days to complete and requires specialized training and reagents as well as extensive lab space.

    In contrast, MycoSEQ™ is a PCR-based assay which offers sensitivity comparable to the culture-based method but with much faster delivery, able to provide results within 24 hours. The rapid testing offered by MycoSEQ™ makes it ideal for in-process testing across the complex biomanufacturing workflow as well as for lot release. It is now widely used and accepted by regulatory authorities including U.S. FDA and EMA, and is offered by WuXi Advanced Therapies as part of our testing portfolio.

    In this webinar you will learn:

    • Regulatory requirements for mycoplasma testing within the cell and gene therapy pipeline
    • How WuXi Advanced Therapies applies their experience to support customers with mycoplasma testing
    • The benefits of the MycoSEQ™ assay compared with culture-based methods
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    Droplet Digital PCR (ddPCR) for Sensitive Testing in Advanced Therapy Manufacturing

    Droplet Digital PCR (ddPCR) for Sensitive Testing in Advanced Therapy Manufacturing

    03.03.22

    Rigorous testing is integral to the development of a novel cell or gene therapy to ensure safety and efficacy of each product. When developing gene therapy products or manufacturing the product itself, accurate quantification of recombinant AAV or lentivirus is crucial, for example to accurately discern final vector titer, or to detect the presence of unwanted replication competent AAV/lentivirus (RCAAV/RCL), helping ensure the safety of new therapies.

    One of the techniques WuXi Advanced Therapies is using for such characterization is droplet digital PCR (ddPCR). Compared with qPCR, ddPCR offers increased sensitivity and precision and removal of PCR bias by measuring the result of thousands of reactions (droplets) for each well. Since signal is measured after PCR cycling (endpoint PCR), error in quantification due to changes in PCR efficiency between or within runs is prevented. No standard curve is required; absolute quantification is achieved by comparing the number of positive droplets versus the volume of sample tested.

    WuXi Advanced Therapies has optimized the ddPCR protocol, using the latest Bio-Rad equipment, as part of our advanced therapies testing arsenal. Incorporating automation into the process has minimized method variability and processing time, so that plate setup and method performance are similar in effort and complexity to traditional qPCR. Removal of a requirement for a standard curve simplifies the assay further, saving time and resources and eliminating any inconsistencies due to incorrect reference selection or amplification errors.  WuXi Advanced Therapies have expertise in utilizing ddPCR for assays requiring high precision within cell and gene therapy testing, such as viral titer assays.

    WuXi Advanced Therapies integrates testing throughout the AAV manufacturing process and offers ddPCR under Good Manufacturing Practice (GMP) standards with several off-the-shelf targets, and as part of in-process and lot release testing. Further, WuXi Advanced Therapies as a Contract Testing Development and Manufacturing Organization (CTDMO) has the capacity to work with clients to design assays which fit product-specific requirements. 

    In this webinar, you will learn about:

    • Applicability of ddPCR to nucleic acid quantitation assays
    • Comparability between ddPCR and qPCR
    • Design of ddPCR tests and controls
    • ddPCR assays offered by WuXi Advanced Therapies and development capability
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    Leveraging the Blow-Fill-Seal Process and Cold BFS Technology for Biologics

    Leveraging the Blow-Fill-Seal Process and Cold BFS Technology for Biologics

    02.01.22

    The advanced aseptic processing of Blow Fill Seal (BFS) technology for primary container liquid packaging has a long and proven history.  For decades, this technology has been gaining prevalence and wide support as a standard of care in the respiratory and ophthalmic markets for the packaging of nebulized liquid and unit and multi dose eye droppers. BFS is a highly automated process that forms a container, fills it with product, then seals it – all without human intervention and within the machine in a Class A environment.  This drastically reduces the risk of microbial and foreign particulate contaminants during the filling process, making BFS a superior form of advanced aseptic packaging.

    BFS packaging is used extensively by organizations for a wide variety of products, including solutions, suspension, and emulsions. While sterile packaging is equally important for biologics and large molecule formulations, some organizations are hesitant to consider BFS because the process uses heat to melt and form plastic resin into a container, which could potentially impact the product’s integrity.

    Woodstock Sterile Solutions’ patented Cold BFS technology and proven history of manufacturing a commercial biologic minimizes that concern by maintaining temperature balance throughout the BFS process. This webinar will cover Blow Fill Seal technology, explain why it is essential for aseptic packaging, and how Cold BFS technology has made BFS a viable solution for biologics and large molecule formulations.

    Key Learning Objectives:

    • An understanding of the BFS technology and manufacturing process
    • Advantages of BFS over glass packaging
    • The impact of temperature on product during the BFS process
    • An understanding of cold BFS processing and its advantages

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    Sterility, Manufacturing & Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals

    Sterility, Manufacturing & Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals

    12.14.21

    The Biopharmaceutical sector has been changing very rapidly from monoclonal antibodies to Cell and Gene Therapy and RNA-based Therapeutics. The growing healthcare needs demand cost effective and rapid manufacturing technologies. The approval of biosimilars and continuous manufacturing has joined hands with manufacturers to meet these demands. This shift from fixed stainless steel to single use systems (SUS) has revolutionized the therapeutic market. The rapid market growth for SUS, composed primarily of plastic components that are sealed and sterilized using irradiation, is expected to continue. This webinar will focus on product development, including sterilization and lab testing strategies, to help ensure there is no contamination in the development and manufacturing of SUS to promote end-user safety.

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    Sustained Release Microspheres: Achieving Success from Post-Feasibility to GMP Manufacturing

    Sustained Release Microspheres: Achieving Success from Post-Feasibility to GMP Manufacturing

    12.08.21

    The drug delivery industry typically focuses on new technologies and confirming proof of concept studies. However, one of the true challenges begins post-feasibility in scaling the desired formulation without impacting critical quality attributes, as well as transferring the process from a R&D laboratory to a GMP manufacturing facility to initiate clinical batch production. This talk will outline the typical steps Oakwood takes during post-feasibility, scale-up, technology transfer, and Phase I clinical batch production. We will discuss some of the challenges we have encountered with previous projects, and solutions to optimize success.

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    Microbiological Testing Considerations for Pharmaceutical Products

    Microbiological Testing Considerations for Pharmaceutical Products

    08.26.21

    Microbiological testing is a critical component to ensuring the quality and safety of pharmaceutical products.  In addition to robust manufacturing processes and controls, an appropriate QC testing strategy can provide assurance that products are free of contaminants and are suitable for their intended use.  Compendial guidance (in some cases, harmonized across the USP, Ph. Eur., and JP) provides general instructions for testing based on validated methodology and long-established microbiological best practices.  However, the application of appropriate methods and techniques depends on various product attributes and quality requirements.  Understanding factors that contribute to method sensitivity and variability is important in generating consistent results and allowing meaningful data evaluation.

    Discussion Points:

    • Introduction to microbiological testing of raw materials, APIs, and finished products
    • Validation of methods
      - Compendial chapters outline general parameters, techniques, and requirements
      - Method Suitability vs. Method Verification/Validation
    • Product specifications and method sensitivity
      - USP/NF monographs and USP <1111> for raw materials, APIs, and finished products
      - Method variability and application of specifications       
    •  General procedures to investigate unexpected results

    Speaker:

    Christopher Gilmer - Microbiology Manager, CMC Analytical Services, Frontage Laboratories


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    How To Ensure Safe, Smart, AND Sustainable Packaging

    How To Ensure Safe, Smart, AND Sustainable Packaging

    08.17.21

    For pharmaceutical and healthcare companies, today’s complex secondary packaging requirements can be an overwhelming challenge. Finding the right structural design and building and maintaining a strong brand, combined with the pressures of meeting sustainability goals can prove tricky. Join us with Colbert Packaging as they present how to achieve packaging solutions that provide The Total Package.

    • Learn the fundamentals of effective package design and production
    • From safety measures to brand differentiation
    • Leveraging technology to get the best results
    • Understanding your sustainable alternatives and environmentally responsible sourcing

    Speakers:

    Bradley David - VP Corporate Technical Sales, Colbert Packaging Corp.

    Clinton Melius - Director of Liquid Inks/North America, HuberGroup

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    New Horizons in Lipid Nano Particle Production

    New Horizons in Lipid Nano Particle Production

    08.10.21

    Tribute must be paid to the hugely impressive efforts of those who reconfigured existing equipment at speed into a "Generation 1" manufacturing process for mRNA vaccines. However, it is unclear that this configuration is optimised to meet future needs.  Micropore will present its fully aseptic, low pressure technology to optimise the technology into a "Generation 2" configuration to improve overall efficiencies for the anticipated major growth in LNP technology as a delivery system for treatment of infectious diseases and cell & gene therapies for hereditary diseases.

    In this webinar you will learn about:

    • The equipment setup specifications and the parameters tested during experimentation by the team at Strathclyde
    • Detailed findings and results from the head of head of Micropore’s Operations team
    • The immediate application for pharmaceutical product manufacturing and the potential foreseen for further developments using this technology


    Presenters:

    • Dr Yvonne Perrie - Professor, Strathclyde Institute of Pharmacy & Biomedical Sciences, University of Strathclyde, Glasgow.
    • Sam Trotter MSc - Operations Manager, Micropore Technologies Ltd
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    Clinical to Commercial Manufacturing: Selecting the Right CDMO for Your Sterile Drug Product

    Clinical to Commercial Manufacturing: Selecting the Right CDMO for Your Sterile Drug Product

    08.04.21

    Taking a drug product from clinical to commercial-scale production is a complex process with numerous variables to consider. Finding an appropriately-sized CDMO to help you go to market can be difficult, especially when manufacturing capacity shortages are common and many CMOs focus on more established or high-volume products. Companies who are developing sterile products, such as injectable or ophthalmic dosage forms, must also ensure manufacturing sites are prepared for the challenges of aseptic manufacturing.
     
    To find the right partner, you must know what to look for in a CDMO. In this webinar from Lubrizol Life Science Health (LLS Health), we will describe how LLS Health’s CDMO Division is meeting the need for commercial aseptic manufacturing capacity through our recent site expansion and explore key considerations when selecting a CDMO for commercial supply, including:

    • The importance of flexibility and transparency
    • Selecting the “right-sized” CDMO
    • Strategies for reducing risk
    • Best practices for project management
    • Streamlining projects with a full-service CDMO

    Speakers:

    Rob Lee - President, Lubrizol Life Science Health – CDMO Division
    Jason SteeleDirector, Business Development, Lubrizol Life Science Health – CDMO Division


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    Hunt for N-Nitrosamines in Medicinal Products

    Hunt for N-Nitrosamines in Medicinal Products

    07.21.21

    In the EMA newsletter published in September 2019, the pharma industry was given a wake-up call regarding the request to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients. This presentation will look at case studies of analytical testing in the three-step request to review the risk for presence of nitrosamines in medicinal products process issued by EMA/FDA.

    • Nitrosamine testing of packaging materials found ‘at risk’ and ‘Fill the gap’ testing to support the paper-based Risk evaluation/assessment

    • Analytical challenges for Confirmatory testing

    • Routine testing as part of changes to the marketing authorization


    Speakers:

    • Ank Reumer - Senior Study Director, Quantitative Methods- Nelson Labs Europe

    • Andrew Teasdale, PhD - Senior Principal Scientist Impurities Management Astra Zeneca

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    From Capital Builds to Staff Augmentation: Tips to Achieving Integrated CQV Strategies

    From Capital Builds to Staff Augmentation: Tips to Achieving Integrated CQV Strategies

    07.15.21

    Although many aspects of integrated CQV programs could be covered by current policies, most organizations can benefit from additional program review and development. Including sufficient procedures and templates can streamline and enhance the process of document development, reviews/approvals, timing of inter-related activities, and overall CQV leveraging strategy.

    An integrated CQV strategy can support current projects and ongoing operations. This webinar will cover integration strategies in several key areas, including:

    1. General Validation Strategy Program Development
    2. Validation Program Governance
    3. Change Management Procedures
    4. Additional Programs:
    • CQV Organizational Structure and Resource Requirements
    • CQV Communication Plan
    • Schedule Logic Development
    • CQV Execution Tracking Tools
    • Cost Management
    • CQV Issues Log, Submittal Log, and RFI Log
    • Project Management and Project Controls Program Development

    Presenters:
     
    • Michael Bogan - President, ICQ Consultants
    • Michael Gatta - Princiapl, ICQ Consultants
    Register Now!