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BioPharma Asia Magazine

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  • Modernizing Biopharmaceutical Manufacturing: From Batch to Continuous Production
    Modernizing Biopharmaceutical Manufacturing: From Batch to Continuous Production Dr Robert Dream & Dr Peter Levison Recorded: Jul 19 2017 66 mins
    The importance and value of continuous bioprocessing, both upstream and downstream has economic and sustainability advantages and due to the modular nature of continuous bioprocesses means that industry is able to adapt more rapidly to changing market demands. Continuous biopharmaceutical manufacturing in the context of other industries that have already successfully adopted continuous processing. Factor other than scientific ones, are the barriers to change from batch to continuous production. an excellent example of the manufacturing strategies of the steel industry in the 20th century, when this industrial sector incrementally switched from batch to continuous operations. biopharmaceutical industry has reached a stage that requires a change in the production paradigm. For a certain class of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in the culture broth. In order to obtain a high quality product, the residence time in the reactor must be minimized. This can only be achieved with continuous cultivation and preferably with perfusion reactors. a brief overview on the types of cell retention devices currently used in biopharmaceutical industry.
    Furthermore, this is a universal production platform that can be extended to other classes of products, such as antibodies, which are relatively stable molecules. continuous manufacturing is as productive and with a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. In essence, the investment for a continuous plant is much smaller compared to a batch-operated one.
  • Implementing Single-Use PAT at seed stage to simplify cell culture operations
    Implementing Single-Use PAT at seed stage to simplify cell culture operations Dr Jose R. Vallejos Recorded: May 24 2017 35 mins
    Single-Use Process Analytical Technologies (PAT) tools have a great potential to not only increase process understanding at the seed stage but also simplify cell culture operations. By utilizing PAT, the risk from bioburden or contamination can be significantly reduced and the overall operating efficiency increased. In fact, PAT also provides a data-driven platform to integrate Process Development and Manufacturing Operations that can mitigate risks associated with technology/process transfer.
  • Developing Practical Single-Use Processes for New Vaccine Formulations
    Developing Practical Single-Use Processes for New Vaccine Formulations Kirsten Strahlendorf Recorded: May 16 2017 76 mins
    New vaccine process designs – and all the kinks that go with them – are typically hammered out in a small scale capacity, for example, prior to manufacturing for early phase human clinical trials. They are then upsized and further defined for industrial scale to supply the vast market. Single-use technologies (SUTs) have been a hot topic for several years now and their advantages well-known: easy product changeover, processing in lower classification areas, reduced CAPEX, elimination of glass, sterility assurance, to name a few. In vaccine manufacturing, SUTs are used throughout the processing stages, from cell culture all the way to filling. SUTs are quickly and conveniently designed, purchased and implemented for short-term manufacturing of clinical trial phase materials. Here a large percentage of new vaccines in Research and Development do not even make it to market.

    As the final production stages are critical as they are the last stages before patient injection, the scope of thisarticle covers SU applications involving drug substance formulations, adjuvant processing, final bulk formulation and filling. The actual process itself may include some or all of the following: filtration, pumping, ingredient addition, mixing, adsorption, filling, labelling, sampling and and storage.

    In this presentation only liquid formulations (“presentations”) will be discussed.
  • Single Use Systems in Biologics Manufacturing & their Impact on Operational Tech
    Single Use Systems in Biologics Manufacturing & their Impact on Operational Tech Gloria Gadea-Lopez, John Maguire, Mark Maselli & Ken Clapp Recorded: Apr 4 2017 62 mins
    The increased interest and adoption of single use systems (SUS) or disposables require that organizations rethink their operational business processes and the design and configuration of manufacturing execution systems (MES). Drawing from their previous experience implementing MES and SUS for biologics manufacturing, the authors discuss the key areas of impact of SUS on operational technology, outline new user requirements, and propose practical solutions for successful MES implementation.
  • Analytical Strategies for Comparability in Bioprocess Development
    Analytical Strategies for Comparability in Bioprocess Development Christine P. Chan, Ph.D & Joe Barco, Ph.D. Recorded: Mar 28 2017 71 mins
    Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the product remains highly similar (not necessarily identical) before and after the change in terms of quality and stability and have no adverse impact on safety and efficacy predicted for the patients. This assessment requires product-specific knowledge gathered through drug development, taking a totality-of-evidence approach. The different levels of information are obtained from analytical studies for characterization of the molecule, animal studies for toxicity, pharmacokinetics and pharmacodynamics for pharmacological activities, and clinical studies for safety/tolerability, immunogenicity and efficacy. This Webinar discusses strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration.

    Sponsored by Unchained Labs

    Presentation Title: Limber up your lab with better tools for comparing biologics

    There’s no magic bullet when it comes to characterizing a protein by structure or function. Specific tests may work for one molecule but not the next. Instrumentation that provides a high degree of flexibility, balanced with low sample consumption and faster time to result, is crucial to keep up with ever changing laboratory needs. Unchained Labs puts biologics characterization front and center for our instrumentation development. We will discuss how our instruments let researchers be more flexible and efficient, while also providing clear data to help make comparability assessments.
  • Subvisible Particle Identification & Characterisation by Multi-Technique Methods
    Subvisible Particle Identification & Characterisation by Multi-Technique Methods Dr Jonas Hoeg Thygesen & Colin Merrifield Recorded: Feb 23 2017 61 mins
    Observable foreign and particulate matter has for a long time been recognized as a critical quality attribute for production of injectable protein formulations. Recently, a focus shift towards these particles and even smaller particles (particulate matter or subvisible particles) has been seen from the pharmaceutical industry, academia and the different regulatory bodies. Two of the central documents in this context are:

    1. The FDA Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products1 and

    2. United States Pharmacopia Chapter 2
  • Challenges and Successes in Externalization of the ADC Supply Chain
    Challenges and Successes in Externalization of the ADC Supply Chain Firelli Alonso, Ph.D. Recorded: Feb 14 2017 74 mins
    Sourcing for the manufacture and control of Antibody-Drug Conjugates (ADCs) used in clinical trials requires strategic planning, establishment of a specialized support network, and execution of several interdependent tasks. ADCs are complex molecules, a fusion of a biological, the monoclonal antibody (mAb), and of small molecules, the linker and the toxic payload. Facilities of acceptable standards for the handling of high potency materials need to be engaged, and there is a limited supply currently. This is further complicated by the fact that there is not one contract facility that has fully integrated services, a “one-stop shop” capable of mAb production, linker and/or payload synthesis, conjugation of mAb to linker-payload to make the Drug Substance, and finally, formulation of the ADC to make the Drug Product. Strategizing the best outsourcing practices for producing and testing ADCs, and establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer, will be further discussed.
  • Continuous Bioprocessing: PAT for Process Monitoring & Control to enable RPR
    Continuous Bioprocessing: PAT for Process Monitoring & Control to enable RPR Jeff Doyle and Dr Paul Jeffers Recorded: Feb 7 2017 57 mins
    Continuous bioprocessing offers potential to enhance productivity and product quality uniformity while simultaneously decreasing facility footprint and associated operational overhead. Advances in technology and increasing commercial pressures are leading to an increased interest in continuous processing across the biopharmaceutical sector. A number of companies are exploring and advancing continuous bioprocessing and this presents a range of opportunity and challenges, including the use of Process Analytical Technology (PAT) for process characterization, process control, and process robustness, in support of a Rapid Product Release (RPR) strategy.
  • Pharmaceutical  Manufacturing in the 21st Century-From Batch to Continuous Manuf
    Pharmaceutical Manufacturing in the 21st Century-From Batch to Continuous Manuf Dr Sau (Larry) Lee & Dirk Leister Recorded: Jun 15 2016 76 mins
    The FDA’s Office of Pharmaceutical Quality (OPQ) is working to encourage the development and adoption of emerging technologies in the pharmaceutical industry that have potential to enhance drug product quality. To achieve this goal, OPQ established the emerging technology team (ETT) program and focuses on advancing regulatory science for emerging technologies. OPQ has identified Continuous Manufacturing as one such emerging technology which has the potential to increase the efficiency, flexibility, agility, and robustness of pharmaceutical manufacturing. The ETT provides industry early engagement opportunities with FDA to receive feedback on potential technical and regulatory issues and FDA’s recommendations for regulatory submission content related to continuous manufacturing and other emerging technologies. In addition, OPQ has started a regulatory science and research program on continuous manufacturing to address remaining gaps in our knowledge and experience. Our research program is currently focused on the following areas in (1) integrated process modeling, (2) understanding of the impact of material properties, and (3) implementation of advanced process control strategies and real time release testing. The results and knowledge developed in this program can be utilized to support the implementation of continuous manufacturing and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science.
  • Mass Spec - an Essential Tool for Characterization of mAbs during Development
    Mass Spec - an Essential Tool for Characterization of mAbs during Development Dr Wei Xu & Dr Henry Shion Recorded: Feb 3 2016 75 mins
    Monoclonal antibodies (mAbs) represent a big portion of therapeutic proteins. Mass spectrometry (MS) coupled with modern separation technologies has become an essential tool in characterization of mAbs within the Quality by Design (QbD) paradigm during development. In this article, we use case studies to discuss the application of MS analysis in clone selection, optimization of fermentation conditions, development of purification and formulation. Specifically, simultaneously detect and monitor variants due to incomplete leader sequence processing, accurately determine afucosylation level of N-glycosylation, characterize host cell proteins (HCPs), identify degradation pathways and critical quality attributes (CQAs) will be discussed.

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