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Autologous cell and gene therapy manufacturers have specific requirements that must be handled in ERP based on maintaining chain of custody, and the potentially lower resiliency of the cells. These requirements are non-negotiable from a controls standpoint. Here are six to make sure you can handle in your ERP system. Thanks for sharing Benjamin Hart!

#CMC professionals know: cell and gene therapies are transforming medicine. 😨 But are statistics keeping pace with complex interactivities in processes? According to Lundbeck's Patricia McNeill, treatments can have 10-20+ critical quality attributes influenced by numerous interconnected process parameters. Traditional statistical approaches are not enough. 🙇♂️ In Philip Ramsey's words, it all comes back to dealing with 𝐜𝐨𝐦𝐩𝐥𝐞𝐱𝐢𝐭𝐲. To deal with complexity, users need 𝐩𝐫𝐞𝐝𝐢𝐜𝐭𝐢𝐨𝐧. "You have to somehow be experimenting in a way to capture this interactive behavior ... 𝐢𝐭'𝐬 𝐚𝐥𝐥 𝐚𝐛𝐨𝐮𝐭 𝐩𝐫𝐞𝐝𝐢𝐜𝐭𝐢𝐨𝐧 ... a measure of how well models you develop interpolate over the design region." To make this work possible, Predictum offers the #SVEM methodology, a machine learning approach that provides accurate predictive modeling. We invite you to learn about SVEM in the case study below. 📺 Watch the full, free webinar at predictum.com: https://bit.ly/4atDEOM -- #predictum #JMP #processdevelopment #processimprovement #drugdevelopment #pharmaceuticals

Tenthpin, a leading global consulting and technology boutique for the Life Sciences industry, established its own product company, Tenthpin Solutions, last year. Tenthpin Solutions addresses the business challenges of the Life Sciences industry with innovative software solutions. If you’re interested in news about Tenthpin Solutions, follow them on LinkedIn: Tenthpin Solutions “Tenthpin has a strong track record of successful co-innovations with Life Sciences industry consortia and SAP, resulting in new standard solutions for Clinical Trial Management, Cell & Gene Therapy Orchestration, and Batch Release Management,” explains Michael Schmidt, Co-Founder of Tenthpin. “Establishing our own product business with Tenthpin Solutions is an evolutionary move that Tenthpin has planned from the outset.” Thomas Weber, Chief Product Officer, sheds light on the product pipeline of Tenthpin Solutions: “With our product Tenthpin Quality Management Evolved (T/QME), we have introduced a market-ready solution that is in high demand. T/QME enriches SAP Quality Management by providing a tailored solution to cover the requirements along lab processes, from sample creation to batch data management. This product is ideal for companies seeking seamless integration of Quality Control and Quality Assurance processes, data, and systems." New solutions will be launched soon. Follow Tenthpin Solutions on Linkedin and stay tuned for more updates! #tenthpinsolutions #coinnovations #lifesciences #followus

Why digitize your Cell & Gene Therapy manufacturing? 🤔 Due to talent shortages, Cell & Gene Therapy companies are increasingly relying on C(D)MOs for manufacturing under stringent regulatory conditions. The growing industry faces challenges such as complex supply chains, strict traceability, patient and cellular variability and tight batch scheduling. These complexities affect quality, compliance and accountability throughout the vein-to-vein process for critically ill patients. So, how can you unlock efficiency, ensure compliance and quality while driving innovation? From improved data management to streamlined operations, our quick-to-read whitepaper offers a comprehensive roadmap to success. 🎯 Learn how... 💡electronic batch records support these above mentioned challenges 💡electronic batch records can support different states of automation 💡digitization improves efficiency and reduces risk for errors ... and much more. Download now and start your digital transformation journey: 👉https://lnkd.in/deq2prhq #cellandgene #advancedtherapies #pharmamanufacturing

We're announcing the release of ARM's latest whitepaper on advanced manufacturing strategies to increase the reach of cell and gene therapies.   As the field progresses and the number of product approvals continues to grow, there is an increasing demand to incorporate higher-volume production to deliver potentially life-saving therapies to expanding patient populations.   ARM's May 2024 workshop brought together therapeutic developers, technology developers, regulatory representatives, and other key stakeholders from across the industry to focus on three primary areas of opportunity: ⚙️ Automation & advanced processes/analytics 💡 Artificial intelligence/machine learning (AI/ML) 🏭 Decentralized manufacturing models A preview of the whitepaper can be found here: https://lnkd.in/ec8rgh6H The paper is free for ARM members on our community portal. Non-members can separately purchase full access to the whitepaper.

𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐒𝐢𝐭𝐞 𝐒𝐞𝐥𝐞𝐜𝐭𝐢𝐨𝐧: Partnering with the 𝐑𝐢𝐠𝐡𝐭 𝐒𝐢𝐭𝐞𝐬 for 𝐂𝐞𝐥𝐥 𝐚𝐧𝐝 𝐆𝐞𝐧𝐞 𝐓𝐫𝐢𝐚𝐥𝐬 🧬💼 Selecting the perfect sites for cell and gene trials is not just a box to tick—it's the cornerstone of success for the entire trial journey. From the capabilities of leukapheresis centers to logistical hurdles and proximity to manufacturing facilities, every detail counts. Moreover, we can't overlook factors like trial longevity and patient retention rates, which can make or break the outcome. 🏥💡 Let's assess the readiness of our biotech-vendor partnership ecosystem for the crucial task of long-term data collection post-trial. And let's not forget the patients—ensuring their continuous care and support beyond the two-year mark is vital. 🤝👩⚕️ Is the biotech-vendor partnership ecosystem ready for data collection after 2 years of treatment follow-up? Since gene therapy (GT) products are designed to achieve therapeutic effects through permanent or long-acting changes in the human body, there may be an increased risk of delayed adverse events. As a result, subjects in GT trials may be monitored for a “long-term follow-up” (LTFU) period lasting as long as 15 years. So how do you manage patients, especially after 2 years of trial participation? 📊🔍 We would be happy to hear your thoughts! 💬 Please feel free to get in touch for more details. Let's shape the future of cell and gene trials together! 🌟💉 . . . #CellAndGeneTrials #ClinicalResearch #SiteSelection #PatientCare #HealthcareInnovation #clinicaltrials #patientcentricity #biotechnology #VentureCapital #subscriptiondrugdev #UbuntuResearch 

The cell therapy industry is poised for growth, but current manufacturing processes pose challenges in cost, scalability, and consistency. We would like to highlight ARM's October whitepaper which delivers valuable insights from industry experts from a workshop earlier in the year. The paper addresses scalability issues and the need to embrace innovative technologies to make life-saving treatments accessible to more patients, particularly highlighting: - automation & advanced processes/analytics - artificial intelligence/machine learning (AI/ML) - decentralised manufacturing models & regulatory hurdles Commenting on the paper, our Global Business Development Lead, Jason Jones concluded, “We’re pleased to see the conclusions and outcomes of this ARM Report on Advanced Manufacturing Strategies and highlight the increasingly urgent need for CGT Manufacturing to ‘Meet the Challenge’ that the success of the therapies is setting. It's clear advanced and full automation is required to meet the scale, quality, lower COGs and sustainability required, but must do so outside of sealed ‘black boxes’. Mediating labour requirements, costs and process complexity is underlined as vital and we agree that fuller automation of current processes can take the workload, hours and process complexity onto itself and increase reproducibility and standardisation. Likewise, it can reduce manufacturing facility size and complexity and increase manufacturing efficiency and output per m2. We particularly agree with how these automation platforms need to be flexible to different process needs. We believe our approach (integrating currently used and proven technology into our platform with minimum process and product change) can facilitate late-stage automation, only when needed, and with the minimum amount of risk. Specifically, we are fully aligned in recognising that to address the challenges in CGT manufacturing and fulfil our responsibilities to future patients, we must do so through knowledge-sharing and collaboration." Please do click on their link and join ARM for full access to the report: https://lnkd.in/ec8rgh6H #celltherapy #biotechnology #pharma #automation

Genomics Market : Use of genomics in specialized/personalized medicine Get Free Sample Pages:  https://lnkd.in/faK8YTH Growth in the personalized medicine market is set to offer an array of opportunities for players operating in the market. Various #pharmaceutical companies are increasingly investing in #personalizedmedicine research. Personalized medicine enables medical practitioners to identify the exact needs of a patient and then prescribe medicines and treatments accordingly. This approach guarantees better care outcomes. Moreover, it is expected that advancements in the field of gene therapy have the potential to replace traditional #drugs and #surgeries by enabling doctors to treat a disorder by inserting a gene into a patient’s cell. #genomics #precisionmedicine #genomicsequencing #dnasequencing #genetictesting #personalizedmedicine #biotechnology #healthcareinnovation #genomicanalysis #genomicdata #bioinformatics #genomicmedicine #healthtech #biotechindustry #genomicsmarket

Why digitize your Cell & Gene Therapy manufacturing? It's simple....see below

Don’t Let Problems Surprise You: Early Problem Detection Makes Your Life Easier! In the world of cell and gene therapy manufacturing, the stakes are high. But guess what? With Process Analytical Technology (PAT), you can dodge those headaches, save time, and keep your budget controller happy. Why PAT is a Game-Changer: 1. Save Time, Save Money: -- Online Monitoring: PAT tools, like the Ovizio Imaging System, keep an eye on your cell cultures 24/7. They catch issues before they turn into big problems. -- Close Loop Control: Automatic adjustments mean optimal conditions are always maintained. No more manual tweaking – it’s hands-free! -- Automation: From data collection to analysis, automation ensures everything runs smoothly without constant supervision. 2. Keep Your Product Safe: -- Early Detection: Spotting issues early means fewer defective batches. Your therapies remain top-notch, and your patients stay safe. -- Hands-Free Operation: With PAT, especially systems like Ovizio, you minimize contamination risks and human error. Your cultures thrive in a stable, controlled environment. 3. Boost Efficiency: --Real-Time Data: Continuous monitoring provides instant feedback, allowing for quick decision-making and immediate action. --Streamlined Processes: With automated and hands-free systems, your workflow is smoother, faster, and more efficient. The Takeaway: Early problem detection not only makes your life easier but also ensures your cell and gene therapy manufacturing is efficient, cost-effective, and reliable. Invest in PAT, like the Ovizio Imaging System, and see the difference for yourself. #GeneTherapy #CellTherapy #ProcessAnalyticalTechnology #OnlineMonitoring #CloseLoop #Automation #HandsFree #EarlyDetection #OvizioImaging #HealthcareInnovation