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BioPharma Asia Magazine

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  • 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.
  • NIR In-Line Monitoring for Drug Product Continuous Process: From Understanding t
    NIR In-Line Monitoring for Drug Product Continuous Process: From Understanding t Yang (Angela) Liu Recorded: Jan 19 2016 59 mins
    During the past decade, continuous processing has steadily gained traction within pharmaceutical industry. The smaller footprint, the reduction or minimization of technology transfer and overall flexibility of these systems generate the economic drivers for change. The advancement of technology, such as integration of process equipment and process analytical technology (PAT) enables concentrated process understanding and effective process control for these systems. There are an increasing number of joint efforts from industries, academia and regulatory agencies in this area. Continuous manufacturing implementations for commercial products are beginning to emerge as companies begin to turned this vision into reality.
    Among all the process analyzers, NIR is still one of the most widely used platform PAT tools in continuous processes. Some critical aspects should be considered for NIR (or other common PAT tools) implementation in continuous processes.
  • Addressing the needs of a growing patient group: geriatric oral drug delivery
    Addressing the needs of a growing patient group: geriatric oral drug delivery Carsten Timpe and Sigrid Pieters Recorded: Nov 18 2015 54 mins
    Because of worldwide demographic changes a dramatic increase of the geriatric population is expected in the next decades. While pediatric drug delivery principles are becoming integrated into the development of new medicines, drug developers are less prepared to appropriately address the specific needs of this booming patient population. This webinar tries to give an overview about the possible drug delivery strategies addressing old age dependent differences. There will be specifically focused on how patient convenience and compliance can be improved, how disease specific drug delivery strategies can help geriatric patients, and how learnings from pediatric drug development can be used as a platform towards geriatric drug delivery.
  • The Paperless Laboratory: A Way Into Process Optimisation
    The Paperless Laboratory: A Way Into Process Optimisation Peter Boogaard Recorded: Nov 5 2015 68 mins
    Peter will share experiences and observations how the scientific high-tech community, can benefit from adopting paperless processes in the laboratory. Is it because paper doesn’t require any significant investment budget, or is it the low barrier to access, since paper even works without power or the need to have access to an information infrastructure, or is it just simply that the “what’s in it for me” question hasn’t been answered satisfactorily for the scientists?
    Cross-functional collaboration between research, development, quality assurance and manufacturing is all about optimising and integrating multi-discipline distributed processes from start-to- finish. A paperless electronic record keeping system will add significant value to support these goals. LIMS, SDMS, LES and ELN products all reduce variability, transcription errors. Do we believe that traditional paper based systems could ever support these complex processes?
  • Single-Use Chromatography – a Feasible Unit Operation?
    Single-Use Chromatography – a Feasible Unit Operation? Dr. Joachim Walter & Dr. Günter Jagschies Recorded: Jul 2 2015 68 mins
    Though single-use technology and the general use of disposables are widely accepted and applied both in process development, pilot plant and selected production processes, they are not in general a reasonable choice at any scale or application. Notably process chromatography is considered a critical unit operation regarding feasibility to single-use application with the chromatographic matrix assumed to be the typical cost driver. But is this really true? The answer to this quite ambivalent: it depends! Numerous young and innovative companies have developed new and/or alternative products which can help to significantly reduce the costs of goods, thus providing an interesting basis for single-use applications. After all, taking into account reasonable scales and suitable manufacturing targets, the doors have been opened widely due to the supply of appropriate low-cost matrices and feasible hardware.

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