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Speed and flexibility are critical for success in #biotherapeutics and cell and gene therapy. John Litz from ILC Dover explains why these factors are essential for a seamless supply chain and how they impact manufacturing efficiency. Watch the video to learn more. #Biopharma #Biopharmaceuticals

Social Pharma Patient-Centric Marketing socialpharma.net >>> Gene&Cell Therapy >> #ADA24: Fractyl pitches potential of GLP-1 gene therapy, but pushes clinical trials back to 2025 #lucidquest #genetherapy #celltherapy

Do you want to learn more about how #processanalyticaltechnologies (PAT) can enhance your #ATMP development processes? Listen to Daria Marsh, Head of Bioprocessing at the Cell and Gene Therapy Catapult, discuss how an automated PAT set up can improve process characterisation and future manufacturing automation, as part of EPR's 'The Future of Bio/Pharmaceutical Analysis Online Summit.' Access the recording: https://buff.ly/3NqXsZr #CellTherapy #GeneTherapy #AdvancedTherapies #ProcessDevelopment #automation #ManufacturingInnovation

The Biopharmaceutical and Gene Therapy Terminology Guide A 600-plus term guide describing the use of spectroscopy and separation science for biopharma applications and also terms associated with biopharm technology. https://lnkd.in/gvHZGwq9

I had the privilege of joining this workshop virtually. There was collaborative discussion with FDA, industry, and academia around what could and should be used as non-proprietary “building blocks” in CGT manufacturing to help streamline costs and make products more accessible to patients. Potential building blocks discussed for AAV included cell banks, unit operations like bioreactor or purification processes, and standardized analytics and reference material. The intent is to have elements that can be transportable across different programs but are not as formal as FDA’s designated “platform technologies” which only apply to licensed products. In his closing remarks, Peter Marks indicated that AAV manufacturers need to realize that innovation is not in the columns and buffers used for manufacturing, but in the construct itself. This resonated with me since I see so much competition in the CDMO space over manufacturing platforms and proprietary reagents, when the real value of a manufacturing process depends on the construct and delivery approach of the gene therapy product. We should focus instead on leveraging the platform-product fit and sharing best practices and knowledge to ensure enough of the right products get manufactured and released to the patients who need them. I’m looking forward to this white paper coming out next year, as well as output from other precompetitive consortia like BioPhorum and FNIH. #genetherapy

Exciting collaboration with GenSight Biologics! Be sure to join Scott Jeffers Ph.D. (Chief Technology Officer) from GenSight Biologics at ASGCT #ASGCT2024 May 9 at 12pm. Details below: Poster 1031 Increased Reproducibility in a Critical Downstream Processing Step allows for Speed to Commercialization of Gene Therapy Product to Treat Leber’s Hereditary Optic Neuropathy (LHON) #verdot I #gensightbiologics I #ASGCT2024 I #innovation I #bioprocessing I #singleuse I #purification

Explore analytical approaches to innovative cell and gene therapies at the annual USP Biologics Stakeholder Forum! Each year, industry, regulatory, and scientific experts gather to discuss pressing challenges at the interface of biotherapeutic quality and innovation. This year’s forum will focus on the analytical challenges associated with cell and gene therapy products, including shortened development timelines due to accelerated regulatory review, small production batches, and in some cases, short shelf lives. Sessions will explore analytical innovations that efficiently and cost-effectively support process and product understanding, process validation, and product release. For more information, go to https://ow.ly/h7oE50QoLYi #celltherapies #genetherapies #analytical #innovation #technology #NGS

Exciting news from the Europe cell & gene therapy market! The increasing array of potential investigational cell and gene therapy products are promoting many companies to strategically embrace acquisitions to solidify their market presence. The market is currently dominated by major players such as Novartis, Gilead Sciences, Spark Therapeutics, Inc., Amgen, and Orchard Therapeutics. For more industry insights, check https://bit.ly/3S7hiv7 #europecellandgenetherapymarket #cellandgenetherapymarket #focusreportsbyarizton #ariztonresearchreveals #marketresearch #researchreport #marketinsights #markettrends #marketsize #marketshare #marketgrowth #marketforecast #marketexpansion #healthcareandlifesciences

Transitioning a cell / gene therapy from the clinical stage to the commercial stage can be challenging from a supply chain standpoint. In this article, Joop Wijdeven, Tjarda Kasteel, & Peter Martens explain why & offer some guidance >> https://lnkd.in/e2f7pAmA #biotech #biopharma #cellandgenetherapy #supplychain

Join Andrea M. Briggs, Sr. Director, Global Cell and Gene Therapy Compliance as she shares insights gained from being the first NA CDMO to gain EMA approval for production of an allogeneic cell therapy drug product, along with approaches to streamline commercialization. Explore: - Critical factors to achieve commercial readiness - Risk mitigation activities - Steps to address process/analytical robustness and reproducibility - Quality control and regulatory considerations Watch now on demand: https://okt.to/nH0N7E #celltherapy #commercialreadiness