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BioPharma Asia Magazine

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  • 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.
  • Potential use of handheld Raman devices as tools for screening medicines Potential use of handheld Raman devices as tools for screening medicines Dr. Patrick Lukulay and Dr. Mustapha Hajjou Recorded: Jun 9 2015 56 mins
    The spread of counterfeit and substandard medicines is a global threat to public health. The sources of most counterfeit medicines found globally were traced to Asia. Although many of these products were found outside the region, many Asian countries are at high risk of exposure to them. There is a need for easy and affordable tools for screening medicines. Handheld Raman devices have gained increasing interest as such tools. Many of the devices available share some advantages in the detection of counterfeit medicines but there are challenges in the detection of substandard products. Fixed-dose combination medicines present even greater challenges.
  • Validation of Microbiological Methods – Expectations for Regulatory Compliance Validation of Microbiological Methods – Expectations for Regulatory Compliance Dr. Rajesh K. Gupta Recorded: May 22 2015 70 mins
    Microbiological methods play a critical role in ensuring safety and efficacy of drugs and biologics. Most microbiological methods are described in compendia and do not need method validation. However, rapid microbiological methods and other alternate methods require full validation. Due to large inherent variability and complexity of microbiological methods, there are challenges in validation of such methods. This webinar will discuss, ways of performing validation of microbiological methods, with a view to achieving regulatory compliance.
  • A risk based approach to continuous processing A risk based approach to continuous processing Rob Bowen Recorded: May 14 2015 60 mins
    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.
  • Patient-Centric Drug Delivery Strategies For Oral Paediatric Products Patient-Centric Drug Delivery Strategies For Oral Paediatric Products Dr. Carsten Timpe & Dr. Paolo Gatti Recorded: Apr 22 2015 76 mins
    The webinar will give an overview about general drug delivery requirements for paediatric drug products and current discussions concerning the EU and US regulations.
    In-depth Case Studies featuring Patient-centric Paediatric formulations, will also be presented.

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