VERDOT’s Post

As supply chain risks intensify with the rise of cell & gene therapies and other complex medicines, innovations such as virtual modeling with digital twin technologies present new opportunities to optimize shipments of these delicate biological therapies. Our latest white paper “Digital Twins and the Cold Chain Experience” examines the forces driving digital twin ecosystems, surfaces examples of digital twin successes from other industries, and discusses the pain points in the current pharmaceutical shipping cold chain that digital twin technology could alleviate. Download it now ➡️ https://hubs.li/Q01YCtC-0 #temperaturecontrol #pharmasupplychain #coldchainlogistics #digitaltwintechnology #integratedsupplychain #AtTheHeartofYourColdChain

🧬 Addressing channel strategy to improve patient access Melissa Lattanzi, VP of Emerging Therapies at Cencora, spoke to Pharmaceutical Executive about the unique challenges cell and gene therapy (CGT) developers face when building their channel strategy. To lay the foundation for effective commercialization, developers must understand where and how patients are treated – whether by community physicians, local hospitals or specialists – as well as clinical requirements and logistical challenges, such as storage capabilities. Delivery of CGTs involves addressing these logistical challenges by streamlining processes and automating workflows to enhance scalability – to improve patient access to potentially life-changing therapies. Read more ➡️ https://lnkd.in/eDe3tfsV #ManufacturingBrighterFutures #AutomateBetterBiology #AccelerateProductDevelopment #ScaleYourImpact

With the implementation date for EU GMP Annex 1 behind us, immediate viable monitoring results of the type delivered by the BioTrak® Real-Time Viable Particle Counter are imperative to high throughput pharma manufacturers. And even more so in Cell & Gene Therapy personalised medicine. To be effective, short-shelf-life ATMPs need to be released before traditional microbiological results are available. The BioTrak® solves that to guard patient safety. 🔗 https://lnkd.in/e-gkrehN #environmentalmonitoring #cleanrooms #pharma #annex1

#Webinar now available on demand! Integrated plasmid engineering and manufacturing process: a unified approach from lab to clinic Pauline Vieugué (Plasmid Engineering Team Leader, Polyplus now part of Sartorius) and Philippe Ledent (Scientific Manager, Xpress Biologics now part of Sartorius) explore an integrated approach for #plasmidengineering and manufacturing, ensuring the integrity of the therapeutic product from lab research to clinical phases Watch this webinar at your convenience to learn about: • A robust plasmid engineering platform to propel gene therapy projects forward with confidence • Methods to eliminate common industry challenges faced when transitioning from discovery grade to higher-quality production • How to de-risk processes and make them cost-effective

Exploring Alignment in Transfection Reagent Release Standards: Insights from BioPhorum Discover a Quality by Design perspective as experts from leading bio/pharmaceutical companies, including our own Andrew Schaefer, MBA, delve into the identification of crucial attributes within the cell and gene therapy manufacturing process. Dive into the comprehensive article for insights into the regulatory landscape, material characteristics, and test requirements. Explore topics such as defining quality target material profiles and attributes, establishing a product control strategy, and identifying critical material attributes. Read the full article ➡️ https://buff.ly/3uAerD4 Learn more ➡️ https://buff.ly/46yPMvL #eurofins #biopharma #celltherapy #genetherapy  

In recent years, there have been remarkable success stories from the field of gene and cell therapy, and particularly from CAR-T-therapies. More and more other approaches are being researched or tested in clinical phases, and some have already achieved regulatory approval. Different approaches to cure (rare) diseases and the business models behind it will be presented here.   We look forward to the contributions to the panel from Benedikt von Braunmühl and the presentations by: Constanca Figueiredo from Allogenetics GmbH Gerd Maass from Roche and Dr. NAWAL PEACOCK, MD. from Vertex Pharmaceuticals   #Genes #Cells #Biotechnology #therapies #DBT2024

Interested in Nucleic acid technologies, Gene and Cell Therapies, New Generation Biologics and Targeted Protein Degraders? Then we hope you have registered for the ESTP congress in Basel from the 26th to 29th September 2023. Click below to find an overview of the four exciting days and sessions of the congress under the banner “Emerging therapeutic Modalities”. https://lnkd.in/d8WjS8xF #ESTP #emergingtherapeuticmodalities #Basel #Nucleicacidtechnologies #GeneandCellTherapies #NewGenerationBiologics #TargetedProteinDegraders

📚 ISPE, a leading industry organization, has recently published a guide that addresses common challenges that may arise when demonstrating comparability across the rAAV product lifecycle. Their newest release, "rAAV Comparability & Lifecycle Mgmt," provides valuable insights into the complex and rapidly evolving world of gene therapy manufacturing. 🔗 Learn more from the guide here: https://lnkd.in/gF5mJQxY 🗣️ Share your thoughts and experiences in the comments below. Connect with us at https://www.brevitas.us/ #genetherapy #manufacturing #lifecyclemgmt #ISPE #ATMPs #comparability #pharmaceuticals #Brevitas

Our webinar resource page is now available for you. Select from a variety of topics. We will be sharing our 2024 webinar program through US Pharmacopeia calendar very soon! #cellandgenetherapy #smallmolecule #pharmaceuticalinnovation #genericpharma #biologics #pharmatech #drugdevelopment #drugdiscovery

Discover what challenges lie ahead of the Cell and Gene Therapy industry 🧬. Benefit from proven working methods that will help you succeed - and increase your speed to market - in this interview with Dr. Judith K.. Our Senior Industry Advisor and Principal Consultant Advanced Therapies, at Körber Pharma #Software, offers an overview and best practices of the iterative approach to a digital therapy process. Find out more about unlocking the potential of your cell and gene manufacturing! Watch the full interview here 👉 https://lnkd.in/dsy3cBQs. #KörberPharma #pharma #cellandgenetherapy #Körber #cellandgene