Pharmaceutical Online

Paul Hanson, Takeda’s head of life cycle management, innovation, and strategy, and an active member of the ISPE, made the case for GenAI as a helper during the 2024 ISPE Europe Annual Conference earlier this year. In his talk titled “How Generative AI is Impacting Pharmaceutical Manufacturing,” he used the words “frictionless access,” which should resonate with anyone who has ever stumbled through a file directory searching for a document. We caught up with Hanson after the conference and asked for a recap. Here’s what he told us. ⤵ https://lnkd.in/ePxRHdxN #pharmaceuticalmanfuracturing #genai #pharmamanufacturing #generativeai

中外製薬 / Chugai Pharmaceutical Co., Ltd.’s ambitious goal to achieve zero emissions at its new UK4 site in Northern Tokyo earned the century-old pharmaceutical company a nod from the ISPE. ISPE will recognize the company at the 2024 Annual Meeting & Expo in Orlando later this year. UK4’s construction project manager, Shingo Goto, answered a few questions about the three zeros approach and other parts of the company’s strategy at the site. Read the full interview ⤵ https://lnkd.in/eCaQqe7N

Elevate your #pharmaceutical knowledge and network with industry leaders at the 2024 ISPE Annual Meeting & Expo! Don't miss out on cutting-edge insights and innovation, 13 – 16 October, in Orlando, Florida, and virtually. Learn more: https://lnkd.in/d8ufRmFa   #ISPEAM24 #ISPEAnnualMeeting 

This is the moment we’ve been waiting for: #FDA is ending its yearlong enforcement discretion and expects companies to be compliant. Companies can be subject to FDA enforcement actions on Nov. 28, and no one wants to become the poster child for noncompliance. Meanwhile, the FDA provided an option for those companies that will not be fully compliant in time: the waivers, exceptions, and exemptions program (#WEE). Read Carl Accettura's full article about what you can expect during the #DSCSA stabalization period. https://lnkd.in/eXKKnQtX #fdaregulation

The #GMP world has several typical space types that function as transition spaces. These are generally air locks and gown rooms but also include locker rooms, dock and warehouse vestibules, and similar functional spaces. In this article, architect Geoff Middleton discusses the multiple overlapping functions and how procedure and arrangement can influence their effectiveness. https://lnkd.in/eRjVXPC7 #pharmaceuticalmanufacturing #gmpmanufacturing

Join the upcoming event - Small Molecule Capacity Update In Outsourced Pharma's webinar series, leading CDMOs share their current available capacity to help you identify options for your development and manufacturing needs. Reserve your spot: https://lnkd.in/e-666tgH In this update, Chief Scientific Officer Dave A. Miller, Ph.D. will update you about AustinPx's experience with first-in-human strategies, solutions for poorly soluble compounds, controlled release, handling of highly potent compounds, and more! https://lnkd.in/eYPzWWSU

New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability This is the moment we’ve been waiting for #FDA is ending its yearlong enforcement discretion and expects companies to be compliant. Companies can be subject to FDA enforcement actions on Nov. 28th. The Drug Supply Chain Security Act (DSCSA) compliance deadline is looming, meanwhile, #FDA provided an option for those companies that will not be fully compliant in time: the waivers, exceptions, and exemptions program (WEE). In this article, industry veteran Carl Accettura takes a deep dive into what pharmaceutical manufacturers should become familiar with the PDG Blueprint and HDA DSCSA Exceptions Handling Guidelines to assess their readiness and translate DSCSA compliance into robust SOPs. Read the full article here: https://lnkd.in/e-mHJHsF #pharmamanufacturing #pharmaceuticalmanufacturing #fdacompliance #supplychain

Join the upcoming event - Small Molecule Capacity Update In Outsourced Pharma's webinar series, leading CDMOs share their current available capacity to help you identify options for your development and manufacturing needs. Reserve your spot: https://lnkd.in/ezkfcbfa In this update, Jeff Tremain will showcase AbbVie CMO and their extensive capabilities, including HPAPI & API, with a particular focus on their Campoverdi, Italy facility which currently has capacity available for near-term projects. https://lnkd.in/e97GtRQK

The Ins And Outs Of Modern Barrier Systems In this article, Richard Denk, hygienic design and containment expert at GMP Compliance Adviser looks at key features of barrier systems, such as restricted access barrier systems (#RABS) and #, and discusses some of their applications. Read the full article: https://lnkd.in/e3U-k_uQ

Join the upcoming event - Small Molecule Capacity Update In Outsourced Pharma's webinar series, leading CDMOs share their current available capacity to help you identify options for your development and manufacturing needs. Reserve your spot: https://lnkd.in/eB2v8Jrw In this update, you will learn about Alcami Corporation's oral solid dose development, solid state characterization, clinical manufacturing, batch scale up, and commercial manufacturing #CDMO #pharmaceuticaloutsourcing #soliddose #oralsoliddose https://lnkd.in/eKV7yB7Q