pharmaintelligence
Understand important upcoming milestones that will impact the likelihood of drug approval or future sales potential for key therapies during a free webinar from Informa Pharma Intelligence, "Q4 Outlook Webinar - Key Catalysts and their Impact on Pharma Markets". During this important session, experts from the Datamonitor Healthcare team, part of the Commercial Strategy Suite at Pharma Intelligence, presented their insights into what to expect during the last quarter of the year.
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Pharmaceutical and biotechnology companies value streamlined services from early-phase development to clinical supply services to commercialization. These services not only provide with improved efficiencies, such as the ease of transition from one development phase to the next, but also remove the challenges of dealing with multiple vendors when transitioning into clinical supplies and commercial availability.
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Pall Corporation
Single-use technology has established itself as an integral part of the biomanufacturing process helping to preserve space, increase flexibility, and save money. Thoughtful design for the handling and transfer of sterile liquids is a key consideration when designing single use systems, and advances in equipment such as sterile connectors have facilitated many of these operations. Assuring aseptic connections are reproducible and sterility is maintained during fluid transfer is underpinned by the design, materials of construction, and in-built quality of the connector. In addition, assessing the risk posed by leachables, which are potentially present in the final drug product, is a regulatory requirement of biopharmaceutical manufacturers. Key to understanding the risk posed by leachables from single-use connectors is data based on agreed test methods, such as BPOG, that enables end users to make informed decisions on patient safety.
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Over the years there have been many frames of reference on the use of process analytical technology (PAT) in the commercial manufacturing space including monitoring, closed-loop control, quality control/real-time release, advanced process control, quality by design, Industry 4.0, etc.
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