adthera bio

🚀 Scaling Out Cell & Gene Therapy Manufacturing: A Digital Approach to Risk Mitigation 🏭 We’re excited to share how adthera bio is leveraging digital twin technology to tackle these challenges head-on. 🔹 Our GMP simulation suite—now virtualized using OUAT! technology—enables us to assess different scaled-out manufacturing strategies: 1️⃣ 4-workstation model 2️⃣ Ballroom-style model with 15+ workstations 3️⃣ 8-workstation model with an associated final fill room By simulating process, people, and material flows, we can identify risks and compliance concerns before implementation—ensuring robust manufacturing continuity and scalability from hundreds to thousands of batches in a compliant environment. In addition, we are planning to test digital solutions in our physical GMP simulation suite to transform the level of visibility in the manufacturing space. 🔬 Key considerations in our risk assessment & digitalisation study: ✅ Process closure is essential—open manufacturing steps must be mitigated before a Grade C ballroom model is viable. ✅ Digital tools like RTLS & RFID are critical for tracking materials & personnel, reducing contamination risks in concurrent manufacturing. ✅ Automation & modular facility design provide scalability while maintaining operational flexibility. ✅ A digital-first strategy ensures regulatory compliance, enhances traceability, and optimizes production scheduling. 💡 The future of CGT manufacturing isn’t just about scale—it’s about intelligent, data-driven decision-making to mitigate risk and maintain uninterrupted GMP-compliant production. What’s your take? Have you encountered scalability challenges in CGT manufacturing? How are you mitigating risks in a high-throughput, multi-product environment? Join the conversation below! 👇 #cdmo #regenerativemedicine #digitalfirst #celltherapy #immunotherapy #innovation #processdevelopment #continousimprovement #gmp #clinicaltrials #atmp #advancedtherapies #personalizedmedicine #gxp #optimization #automation #bestinclass #rightfirsttime #celltherapymanufacturing #innovation #digital #partnerships #collaboration #networking #digitaltransformation #quailtycontrol #qualityassurance #GMP #simulation #manufacturing #processdevelopment Miltenyi Biotec ScaleReady Fresenius Kabi PHCbi Global Terumo Blood and Cell Technologies ChemoMetec

🔬 Scaling Out Cell & Gene Therapy Manufacturing: What Are the Key Risks? 🏭 The ballroom manufacturing model offers efficiency and scalability for Cell & Gene Therapy (CGT), but it comes with significant operational challenges—especially when relying on paper records & procedural controls. At adthera bio, we’ve been assessing these risks in depth, and we want to hear from the community! 📊 Poll: What do you see as the biggest risk in a scaled-out ballroom cleanroom using paper-based controls? 1️⃣ Risk assessment of containment failure (e.g., vector leak) with limited data 2️⃣ Managing manufacturing batch records effectively 3️⃣ Batch production scheduling – workforce & materials 4️⃣ Environmental & facility monitoring – volume & complexity The transition to digitalised and automated manufacturing is key, but for those currently operating in paper-driven environments, risk mitigation strategies must be robust. 💬 What’s your take? Have you faced challenges in a ballroom model? What steps do you see as critical to ensuring compliance and efficiency in a multi-product, concurrent manufacturing environment? Let’s start the discussion! 👇 Learn more at info@adthera.bio | adthera.bio #cdmo #regenerativemedicine #digitalfirst #celltherapy #immunotherapy #innovation #processdevelopment #continousimprovement #gmp #clinicaltrials #atmp #advancedtherapies #personalizedmedicine #gxp #optimization #automation #bestinclass #rightfirsttime #celltherapymanufacturing #innovation #digital #partnerships #collaboration #networking #digitaltransformation #quailtycontrol #qualityassurance #GMP #simulation #manufacturing #processdevelopment

🔗 Navigating Supply Chain Complexity in Life Sciences 🚀 Did you know that over 70% of IT projects fail? The top reasons? ❌ Poorly defined system requirements ❌ Lack of process maturity ❌ Unrealistic timelines ❌ Inaccurate budgeting At adthera, we understand that selecting and implementing the right supply chain system is critical for operational success. Our expert-led approach ensures: ✅ Clear definition & documentation of supply chain requirements ✅ Comprehensive vendor assessments to find the best-fit solutions ✅ Solution sandbox testing to match business needs ✅ Implementation & validation evaluation to determine total cost of ownership With decades of experience in life sciences and digital transformation, we help companies streamline operations, mitigate risks, and maximize ROI. 📩 Connect with Kwok Pang, our Chief Digital Officer, to see how we can help Learn more at info@adthera.bio | adthera.bio #cdmo #regenerativemedicine #digitalfirst #celltherapy #immunotherapy #innovation #processdevelopment #continousimprovement #gmp #clinicaltrials #atmp #advancedtherapies #personalizedmedicine #gxp #optimization #automation #bestinclass #rightfirsttime #celltherapymanufacturing #innovation #digital #partnerships #collaboration #networking #digitaltransformation #quailtycontrol #qualityassurance #GMP #simulation #manufacturing #supplychain #processdevelopment

🎉 Happy Chinese New Year 2025 – Year of the Snake! 🐍 As we step into the Year of the Snake, let us celebrate this season of renewal, wisdom, and transformation. The snake symbolizes adaptability, intelligence, and strength – qualities that inspire success and progress in our personal and professional journeys. To our valued customers, colleagues, and friends: ✨ May this year bring prosperity, good health, and endless opportunities to shine. ✨ May your endeavors be met with wisdom and grace, leading to remarkable achievements. Thank you for being part of our journey. Together, let’s make 2025 a year of extraordinary growth and success! 🎊 新年快乐! Wishing you and your loved ones a joyful and prosperous New Year! 🎊 #ChineseNewYear #YearOfTheSnake #HappyNewYear2025 #Prosperity #Growth #AdtheraBio

🚀 What’s Holding Your Organisation Back? Let’s Discuss! 🚀 The path to clinical or commercial success in cell and gene therapy is no small feat. Every organization faces unique challenges, but some hurdles seem universal. We want to hear from you! 💬 👉 What is the greatest technical hurdle in your organization today delaying the acceleration of your asset? 1️⃣ Process optimization and validation 2️⃣ Training, development & retention of staff 3️⃣ Supply chain management 4️⃣ QMS preparation & implementation 📣 Share your thoughts in the comments or vote for your top challenge! Let’s start a conversation and uncover how we can collectively drive innovation and overcome these barriers in our field. 💡 Your insights might inspire solutions that redefine what’s possible!

🌟 Transforming Cell & Gene Therapy with Innovation and Expertise 🌟 At adthera, we are committed to empowering the cell and gene therapy (CGT) industry through cutting-edge solutions and unparalleled expertise. With over 130 years of combined experience, our team drives success across every stage of the therapeutic journey. 🔬 What we do: -Process Development: Crafting innovative solutions with expert precision. -Manufacturing Science & Technology: Delivering tailored processes using deep expertise in major cell therapy platforms and technologies. -Technology Transfer: Accelerating GMP process transfer through our dedicated GMP Simulation Suite. -Quality & Regulatory Compliance: Ensuring compliance with a pragmatic, "Right First Time" approach. -Digital & Data: Leveraging advanced technologies for innovation and insight-driven decisions. With a focus on collaboration, innovation, and excellence, Adthera stands as a trusted partner to help you achieve outstanding outcomes in CGT. 🔗 Explore our services and discover how we can support your success: adthera.bio #cdmo #regenerativemedicine #digitalfirst #celltherapy #immunotherapy #innovation #processdevelopment #continousimprovement #gmp #clinicaltrials #atmp #advancedtherapies #personalizedmedicine #gxp #optimization #automation #bestinclass #rightfirsttime #celltherapymanufacturing #innovation #digital #partnerships #collaboration #networking #digitaltransformation #quailtycontrol #qualityassurance #GMP #simulation #manufacturing #processdevelopment

Happy New Year from all of us at adthera! 🎉 As we step into 2025, we want to take a moment to express our heartfelt gratitude to our customers, partners, and the entire cell and gene therapy community. Your trust and collaboration have been instrumental in driving innovation and delivering life-changing solutions this past year. Here’s to a new year filled with continued success, groundbreaking advancements, and strengthened partnerships. Together, let’s make 2025 a transformative year for science and patients worldwide. Wishing you and your loved ones a prosperous, healthy, and joyous New Year! 🌟 #HappyNewYear #InnovationInAction #CellAndGeneTherapy #PartnershipsForProgress

What are the key aspects to the success of a scaling biotech business? As part of our "Scaling Innovation in Advanced Therapy Manufacturing" series, Chris Hamilton spoke with Colin Sims, CEO & Director at adthera bio to discuss the formation of adthera and the intention of creating a service business which was highly transparent, yet highly digitised with real time capability. Watch the latest episode here: https://lnkd.in/emTSzece #Innovation #Leadership #Technology #ExecutiveSearch #WhereLeadershipMatters

Thanks to the Miltenyi Biotec team for supporting a novel way of communicating challenges in the GCT arena. Here at adthera bio, we have a focus on digital solutions for the future manufacturing and development needs of the cell therapy industry. Reach out if you would like to know more about our journey. #digitalfirst #atmp #rightfirsttime

What's stopping us? What's holding the industry back in delivering ATMPs at scale to patients? The panel session entitled: Make Them Better at #AdvancedTherapiesIntegrates delved deep into this question: ➡️ Consider the phase - we're at the beginning still (think mobile phones 35 years ago!) 🤝 Collaboration - including finding common/best systems and commercial niches 💻 Digitalisation - how can it support us and where are the low hanging fruits (automation in data collection and exchange, for example) 💪 Resilience in the supply chain - and its link to visibility 📈 Risk - and how to manage and learn from other industries to manufacture at scale 👍 Standardisation - across the board, from workflows to AI Thanks to the panellists for the dynamic discussion - Rebecca Street from RoslinCT, Katy Newton from Achilles Therapeutics plc, Antoine Espinet from MFX, Edwin Stone from Cellular Origins, Kwok Pang from adthera bio and facilitator Stephen Ward, Chief Technology Officer, Cell and Gene Therapy Catapult