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A risk based approach to continuous processing

The article considers the opportunities for risk based change in facility design through quality by design (QbD) and advances in PAT. It suggests that the inclusion of a mix of biopharmaceutical products alongside oral solid dose products could work based on a manufacturing dancefloor concept. Further that both upstream and downstream may be considered in a new light with the potential for in-process real-time testing and approval significantly reducing or withdrawing entirely the need for work-in-progress (WIP) inventory and quarantine storage needs as supply chain management processes integrate.
Recorded May 14 2015 60 mins
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Presented by
Rob Bowen
Presentation preview: A risk based approach to continuous processing
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  • mAb Industry in China: Biosimilars vs. Innovative Biologics Jun 18 2018 10:00 am UTC 45 mins
    Dr. Joe X Zhou is the CEO of Genor Biopharma, a VP and the R&D head of 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
  • Manufacturing strategies for Biosimilar: A case of continuous capture Jun 15 2018 8:30 am UTC 75 mins
    Solomon Alva, Biocon
    Continuous manufacturing is an emerging technology in biopharmaceutical industry. The focus of this webinar is a case-study on the benefits of continuous Protein A capture on productivity, capacity utilization and buffer consumption. The potential challenges of adopting the technology such as its integration with cell culture and low pH incubation step has been discussed. There is promise of this technology as an effective platform, and potential of additional savings when considering new generation Protein A resins and in-line concentration technologies.
  • Fully continuous biosimilar manufacturing framework: A case study Jun 14 2018 8:30 am UTC 75 mins
    Samir Varma
    Biologics manufacturing has traditionally been in fed batch mode for the last 2 decades. During the early stages of biologics manufacturing, lower cell line productivity and product instability necessitated the usage of perfusion technology. As productivity increased and mabs became more stable, perfusion was replaced by fedbatch technology, as they were simpler to scale up. However, during the past 2-3 years, the perfusion technology is making a comeback due to the novel continuous chromatography technology. Connecting the perfusion bioreactor to the continuous chromatography system creates a continuous flow of drug substance and promises the following advantages

    The facility footprint for a continuous manufacturing plant would be substantially lower. Our calculations show that a 10-fold reduction in bioreactor size is possible with continuous bioprocessing. So the capacity of a 2000L Fed batch Bioreactor can be achieved by a 200L continuous bioreactor. This reduces the capex by about five fold.
    Consumption of media per amount of DS produced is the same for fedbatch and perfusion, although the cost per liter might be lower for perfusion as it could be a more diluted version of the fedbatch media ,
    Another major cost in bioprocessing is the Protein A resin. A significantly smaller Protein A column could be used in the continuous process and the utilization could be maximized by this strategy.
    As the process is more dynamic in continuous, automation and in-line analytical tools are essential for the successful implementation.
    Enzene Biosciences is on the forefront of the development of the continuous bioprocessing. We are in the processing of building a cGMP plant that would have a fully integrated continuous bioprocess. We have already complete a proof of concept studies in pilot scale (50L)
  • Advances and Challenges in Vaccine Development and Manufacture Jun 11 2018 2:00 pm UTC 75 mins
    Tony D’Amore, Sanofi Pasteur
    This webinar reviews the constraints and complexities of vaccine product development and manufacture.
    The evolution of bioprocess and analytics innovation and technologies to overcome these challenges are discussed.
    The strategy and leveraging of innovation and technology for rapid product development and accelerating timelines is described.
    Case studies to illustrate the advances in vaccine development and manufacture are illustrated.
    A look into the future with state of the art technologies.
  • Subvisible Particles Matter, Developments in Regulations and Low Volume Methods Jun 7 2018 2:00 pm UTC 75 mins
    Dr Satish K Singh, Lonza
    The need to measure and characterize proteinaceous particles in therapeutic protein products has been emphasized by regulators. USP is a new chapter that addresses the limitations of USP for therapeutic proteins in measurement of subvisible particles. USP is a guidance chapter addressing the task of characterization of particles with the emphasis on proteinaceous particles. Furthermore, regulatory authorities require that sponsors understand the submicron particle size range of the products also. This article will look at latest regulatory developments, key aspects of the measurement of subvisible and submicron particles in biotherapeutics, as well as the utility of low volume methods.
  • Finding the Common Road to Quality for Single Use Materials Jun 6 2018 4:00 pm UTC 75 mins
    Presented by Dr Trishna Ray-Chaudhuri, Genentech
    - GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing.  The drug product produced in clinical studies are given to patients.

    - GMP practices followed in producing the single use assemblies will ensure that there is no risk to patients in clinical trials and future commercial products. 


    -Single use assemblies will not be accepted by regulatory agencies and internal quality departments as an alternative to stainless steel tanks.

    -The perception will continue that there is inadequate quality controls on single use assemblies as GMP practices are not adequately followed.

    - Implementation of single will be inhibited
  • Extractable Study Design & Data Evaluation of Polymeric Product Contact Material Jun 5 2018 2:00 pm UTC 75 mins
    Dr. Ping Wang, Principal Scientist, Janssen R&D
    Concerns over the safety and drug product qualities due to extractables and leachables (E&L) from polymeric Product Contact Materials (PCM), especially single use systems, in the manufacturing, packaging and delivery of biologics have increased in recent years. Based on surveys and author’s experience, almost all major regulatory agencies require the E&L risk assessment of PCM for new biologics license applications (BLA). To ensure the E&L data are suitable for the assessment of intended application of the PCM, the health authorities are paying close attention to the study design, analytical assays employed, and how the extractable data being used to conduct a safety risk assessment of the materials. The key to the success is to ensure the study design and data interpretation is product and process specific. The lack of relevant E&L data from suppliers presents end-users a great challenge. Strategies of developing relevant extractable data and applying that in the toxicological evaluation will be discussed.
  • Current USP Perspectives on a Rapid Sterility Test May 30 2018 8:00 am UTC 75 mins
    Dr David Roesti, Novartis/USP
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
  • Environmental Monitoring Trend Analysis Tools May 23 2018 2:00 pm UTC 75 mins
    Steve Walton
    Qualitative analysis of environmental monitoring data is vital for pharmaceutical quality groups. Essential to identifying evolving microbial trends are the means to effectively parse and analyze EM results. To make the best use of the tools available, they must be used with a full understanding of their value and limitations. In this paper, the pros and cons of several EM trend analysis tools will be presented to aid microbiology experts to qualitatively evaluate EM performance data.
  • Integration of Disposable Components into Traditional Stainless-steel Facilities May 22 2018 2:00 pm UTC 75 mins
    Ron Bates, Bristol-Myers Squibb
    This presentation will analyse the benefits and limitations associated with the implementation of single-use technology at a large-scale, multi-product commercial manufacturing facility. By integrating single-use components into a stainless steel facility, a hybrid equipment approach enhances manufacturing flexibility while enabling an accelerated manufacturing cadence.
  • Implementation Strategies and Challenges for SUT at Commercial scale May 17 2018 5:00 pm UTC 75 mins
    Adam Goldstein, Roche/Genentech
    For over 10 years, single-use technology (SUT) has been a growing buzzword in the biomanufacturing industry for its advantages in speed, flexibility, and cost. A recent 2015 BioPlan Associates, Inc. industry survey of biopharmaceutical manufacturers, contract manufacturing organizations, industry vendors, and direct material suppliers identified the ‘Top Concerns’ for why biopharmaceutical manufacturers are choosing to increase their use of disposables. The top three reasons were (i) Eliminates cleaning requirements, (ii) Reduces time to get facility up and running, and (iii) Reduces capital investment in facility & equipment. These reasons are no surprise, as elimination of steam in place (SIP) and clean in place (CIP) allows for a reduction of required piping and controls, which in turn significantly decreases capital costs, design engineering, and field installation times.

    While these are some of SUT’s core drivers, their validity among that of many additional drivers have already been analyzed and proven at length. Perhaps the more interesting reasons for the continued focus on SUT are the growing industry trends towards modular flexible facilities and lean manufacturing.

    In order to adapt towards more targeted therapies for niche populations, biopharmaceutical manufacturers will need to produce multiple high potency products, with greater changeovers, and at smaller batch sizes.4 By significantly reducing capital outlay, disposable modular facilities allow for both product and geographical manufacturing flexibility. Production is thus enabled at a lowered associated risk wherever assets are best utilized and production costs minimized, such as in emergent markets.
  • Current Perspective on Rapid Sterility Test May 17 2018 2:00 pm UTC 75 mins
    David Roesti, PhD, Novartis Pharma AG 
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
  • End User Perspective on Setting in-Process Endotoxin Limits May 15 2018 8:00 am UTC 75 mins
    Dr Friedrich von Wintzingerode, Roche/Genentech
    There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This webinar will present a concept for setting in-process  limits and a case study which allows to understand the underlying rationales and challenges. 
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production May 10 2018 2:00 pm UTC 75 mins
    Sune Klint Andersen, Janssen Pharmaceutica
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
  • Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test May 4 2018 2:00 pm UTC 75 mins
    Karen Zink McCullough of MMI Associates & Kevin L. Williams of BioMérieux
    Title: Preview of USP’s Informational Chapter, Guidelines on the Endotoxins Test
    Presenter: Karen Zink McCullough, MMI Associates
    The retirement of FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge
    on LAL testing. Some of these gaps include: Guidance on RSE:CSE standardization, Guidance on Training,
    Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter, that will appear in the
    July/August issue of Pharmacopeial Forum, provides information and recommendations on these topics and
    more. This Webinar will provide an overview of the contents of this new informational chapter.

    Title: Regulatory Compliance of Alternative Methods
    Presenter: Kevin L. Williams, BIOMÉRIEUX
    Recombinant Horseshoe Crab Factor C (rFC) tests are endotoxin-specific alternatives to Limulus Amebocyte Lyste
    (LAL). The United States Food and Drug Administration included rFC in their Guidance for Industry in 2012 and in
    2016 the European Pharmacopoeia followed suit. Recently, the Japanese Pharmaceutical and Medical Device
    Agency published a collaborative study demonstrating equivalence between rFC and LAL. This presentation will
    provide an overview of how alternative method validation of rFC methods is conducted in accordance to USP
    chapters < 1225 > and < 85 >.
  • Current Progress in Approaches for The Safety Assessment of E&L Recorded: Apr 6 2018 75 mins
    Kim Li, PhD, DABT, MPH, Amgen Inc.& Erica J. Tullo, Technology Manager, E&L – Analytical Labs, West Pharmaceutical Service
    Title: Current Progress in Approaches for The Safety Assessment of E&L
    Presenter: Kim Li, PhD, DABT, MPH, Amgen Inc
    Summary: This Webinar will review the current progress in the risk management of extractables and leachables (E&L) impurities with focus on protein therapeutics. While toxicology assessments of E&L impurities are maturing toward best practices, their potential impact to product quality requires new approaches from the toxicologist toolbox. This webinar will discuss the in silico prediction of chemical functional groups that pose high risk of covalent binding, potentially leading to structural modifications of proteins and impact to quality attributes.

    Title: A Practical Approach to Extractables and Leachables
    Presenter: Erica J. Tullo, Technology Manager, E&L – Analytical Labs, West Pharmaceutical Service
    Summary: While many realize that regulatory agencies require extractable and leachable (E&L) information, many may not have knowledge of how to design an appropriate extractables study that will lead to proper selection of targets in leachables testing. During the extractables study, it is important to choose the most appropriate solvents and extraction conditions for the type of packaging components under evaluation. It is also important to consider a simulation study in which the entire system is assessed. Since leachables are typically a subset of extractables, the design of the extractables and simulation studies can significantly impact the subsequent leachables method development and monitoring. This presentation will highlight different considerations of each phase of E&L testing.
  • SUS Leachable Testing: Leachable Study Design for Single-Use Components Recorded: Mar 20 2018 69 mins
    Kathryn McGohan
    The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharmaceutical and Vaccines Manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the Best Practices for Leachables Study Design by end users and will include a case study to highlight the importance of the study design.
  • Process analytical Technology for Upstream Bioprocessing Recorded: Mar 5 2018 71 mins
    Erica Fratz-Berilla & LCDR Agarabi
    In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence (COE) in Manufacturing Science and Innovation, studies Process Analytical Technology (PAT) for upstream bioprocessing, focusing on the production of monoclonal antibodies. These capabilities are being leveraged to study continuous bioreactor cell culture production and compatible PAT tools. Case studies are presented that illustrate collaborative laboratory research being conducted on PAT tools for upstream bioprocessing to support regulatory decision making.
  • Efficient execution of biologics manufacturing – The role of Finite Scheduling Recorded: Feb 14 2018 47 mins
    Gloria Gadea-Lopez, Ph.D., John Maguire and Megan Rabideau
    The success of manufacturing relies on the availability of all the resources –personnel, materials, equipment, work instructions - , orchestrated in such a way that the operations proceed in an efficient and predictable manner. This article describes the implementation of a finite scheduling system for biologics production, the foundational work required prior to project launch, lessons learned, and benefits achieved from this deployment.
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  • Live at: May 14 2015 8:00 am
  • Presented by: Rob Bowen
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