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X-WR-CALDESC:Events for OTRADI
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DTSTART;TZID=America/Los_Angeles:20200708T080000
DTEND;TZID=America/Los_Angeles:20200708T090000
DTSTAMP:20200622T235924Z
CREATED:20200622T235924Z
LAST-MODIFIED:20200622T235924Z
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SUMMARY:De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools
DESCRIPTION:Rebecca Michael\, PhD; Senior Group Leader\, Cell and Molecular Biology Group \nThere is a high attrition rate during the development of biotherapeutics impacting the high cost of development. Early identification of the preferred expression host for manufacturing\, along with lead candidate screening and material supply can help to reduce both attrition rates and cost. Due to the trend towards the increased complexity of protein therapeutics\,  the use of early stage in vitro expression to assess and identify risks enables the development of process strategies to mitigate risks as early as possible and maximize the outcome of developing biotherapeutics. Early genetic assessment of expression cell lines can support cell line characterization and can help to confirm identify stability concerns at an early stage.
URL:https://www.otradi.org/event/de-risking-the-development-of-biotherapeutics-using-early-stage-in-vitro-expression-and-genetic-characterisation-tools/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:37.09024;-95.712891
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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200624T090000
DTEND;TZID=America/Los_Angeles:20200624T100000
DTSTAMP:20200622T235622Z
CREATED:20200622T235622Z
LAST-MODIFIED:20200622T235622Z
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SUMMARY:Biologics Drug Product Development: Challenges at the Interface of Formulation\, Primary Packaging and Application
DESCRIPTION:As we see pipelines moving to progressively complex biologics—for example\, antibody drug conjugates\, bispecific antibodies\, fusion proteins and other antibody derivatives—the question of a well designed drug product becomes even more pertinent. \nWithin the drug product field\, pre-filled syringes and other combination products have been receiving increasing attention as the container closure system of choice for injectable drug products\, where subcutaneous (SC) self-administration is preferred. \nAs an integrated approach for Biologics product development at the interface of formulation\, primary packaging and application is required to ensure that the final QTPP (Quality Target Product Profile) is met\, this presentation will showcase the impact of different protein and placebo formulations on particle formation and the functionality of pre-filled syringes\, incl. a supporting case study. \nAlso\, this presentation will highlight a focus on early clinical studies\, in regards to the MABEL approach and associated challenges. There will be a second case study assessing the performance and compatibility of CSTDs (closed sterile transfer devices) with product formulation\, as their usage has increased post issuing and effectiveness of the USP 800 monograph. \nSpeaker: \nSusanne Joerg\nHead of Pharmaceutical Development in Drug Product Services
URL:https://www.otradi.org/event/biologics-drug-product-development-challenges-at-the-interface-of-formulation-primary-packaging-and-application/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:37.09024;-95.712891
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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200623T070000
DTEND;TZID=America/Los_Angeles:20200623T080000
DTSTAMP:20200622T235703Z
CREATED:20200622T235043Z
LAST-MODIFIED:20200622T235703Z
UID:10000436-1592895600-1592899200@www.otradi.org
SUMMARY:Quality From the Start: Preparing for a Successful Transition From Late Stage Discovery to the Clinic
DESCRIPTION:Abdelaziz Toumi\, PhD; Senior Director\, Head of Commercial Solutions Ibex™ Design & Develop \nNoel Smith\, PhD; Head of Immunology\, Applied Protein Services \nAdvancing an innovative drug from late stage discovery into the clinic is the most-critical step in drug product development. While drug developers would like to gain as much information on the product as possible\, the scientific focus must be on the drug design for optimal efficacy and safety at this stage. \nThis is when key decisions are made that have a long-term impact and pave the way for clinical and commercial manufacturing as well as the future supply chain. In this early phase\, it is less about speed\, and more important to focus on quality from the start. During this webinar\, we will discuss and discover: \n\nWhat pitfalls to avoid in order to seamlessly advance a new drug from late stage discovery into clinic\nHow to efficiently manage the manufacturing process\nWays to reduce time into clinic and equip drug candidates with a robust CMC-package\nHow to add value as you advance from one clinical phase to the next and are looking for investors and partners
URL:https://www.otradi.org/event/quality-from-the-start-preparing-for-a-successful-transition-from-late-stage-discovery-to-the-clinic/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:37.09024;-95.712891
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