SCTbio

It's been a busy month since ARM's Meeting on the Mesa. We've opened a new office and announced a strategic partnership to expand our presence and capabilities in the US. However, we have had time to reflect and digest the brilliant presentations and insightful panel discussions. With a packed agenda and endless networking, it's impossible to get to every session, so we focused on manufacturing and CMC-related content... Here are some learnings and things we're excited about: 1️⃣ The AI and automation revolution 2️⃣ Progress in process 3️⃣ Evolving regulatory frameworks 4️⃣ Potency assurance strategies What did we miss?

In the interests of building partnerships, we were delighted to host the Swiss ambassador, H.E. Urs Bucher, and his embassy colleagues at our HQ in Prague. Our CEO, Luděk Sojka, and our Head of Manufacturing, Klára M., led a tour of our state-of-the-art GMP and lab facilities. Alongside colleagues from SOTIO Biotech, we discussed our cutting-edge work in advancing cancer research and manufacturing of #celltherapies. We are grateful for the engaging discussions with Your Excellency. Thank you for your visit and the insightful exchange!

If you missed our announcement last week, there's a great summary in Forbes. We have established a new office in Boston, Massachusetts and entered into a strategic partnership with Susan B. Nichols, CEO, Propel BioSciences. "𝘛𝘩𝘪𝘴 𝘤𝘰𝘭𝘭𝘢𝘣𝘰𝘳𝘢𝘵𝘪𝘰𝘯 𝘮𝘢𝘳𝘬𝘴 𝘢 𝘴𝘪𝘨𝘯𝘪𝘧𝘪𝘤𝘢𝘯𝘵 𝘮𝘪𝘭𝘦𝘴𝘵𝘰𝘯𝘦 𝘪𝘯 𝘚𝘊𝘛𝘣𝘪𝘰'𝘴 𝘦𝘹𝘱𝘢𝘯𝘴𝘪𝘰𝘯 𝘪𝘯𝘵𝘰 𝘵𝘩𝘦 𝘜𝘯𝘪𝘵𝘦𝘥 𝘚𝘵𝘢𝘵𝘦𝘴 𝘢𝘯𝘥 𝘴𝘵𝘳𝘦𝘯𝘨𝘵𝘩𝘦𝘯𝘴 𝘪𝘵𝘴 𝘢𝘣𝘪𝘭𝘪𝘵𝘺 𝘵𝘰 𝘴𝘦𝘳𝘷𝘦 𝘤𝘭𝘪𝘦𝘯𝘵𝘴 𝘪𝘯 𝘰𝘯𝘦 𝘰𝘧 𝘵𝘩𝘦 𝘮𝘰𝘴𝘵 𝘥𝘺𝘯𝘢𝘮𝘪𝘤 𝘮𝘢𝘳𝘬𝘦𝘵𝘴 𝘧𝘰𝘳 𝘤𝘦𝘭𝘭 𝘢𝘯𝘥 𝘨𝘦𝘯𝘦 𝘵𝘩𝘦𝘳𝘢𝘱𝘺 𝘪𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯 𝘪𝘯 𝘵𝘩𝘦 𝘸𝘰𝘳𝘭𝘥." 📚 Read the full article here - https://lnkd.in/eEJFq2GG

📣 Announcement: SCTbio expands into the US market 📣 We're delighted to announce that we have established a new office in Boston, Massachusetts. The new office will provide local representation to better serve U.S.-based clients, offering comprehensive services in cell and vector manufacturing and leukapheresis network solutions to support clinical trials and commercialization efforts both in the U.S. and globally. Our CEO, Luděk Sojka, commented “The demand for high-quality cell and vector manufacturing and leukapheresis materials is rapidly increasing as the field advances. Our team brings over 14 years of experience in clinical trial manufacturing, and we are eager to support U.S.-based biopharmaceutical companies in advancing their therapies from process development through to Phase III clinical trials and beyond.” As part of this strategic move, we've also entered into a strategic partnership with Propel BioSciences, a boutique consultancy led by Susan B. Nichols, an accomplished executive with 14 years' experience in the cell and gene therapy field. This collaboration marks a significant milestone in SCTbio’s expansion into the United States, enhancing its ability to serve clients in one of the world's most dynamic markets for cell and gene therapy innovation. Read the full press release at - https://lnkd.in/evaBEavF

We're thrilled that Susan B. Nichols is representing us at Meeting on the Mesa this week! If you have any questions about: 🇺🇸 Our expansion into the US 🏭 CAR-T and viral vector manufacturing 🏥 Leukapheresis collection ...reach out to Susan! #CGMesa24

𝐎𝐩𝐭𝐢𝐦𝐢𝐳𝐢𝐧𝐠 𝐀𝐩𝐡𝐞𝐫𝐞𝐬𝐢𝐬 𝐋𝐨𝐠𝐢𝐬𝐭𝐢𝐜𝐬: 𝐊𝐞𝐲 𝐭𝐨 𝐄𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐂𝐃𝐌𝐎 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩𝐬 𝐢𝐧 𝐂𝐞𝐥𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐲   Logistics should not be an afterthought for a cell therapy CDMO. Time-critical is an understatement when it comes to cell therapies, if we can’t get starting materials or final drug products through customs and to the patient, we don’t have a sustainable therapy. We’ve been building a close relationship with time:matters for many years, and our teams work seamlessly to speed up clinical development without compromising quality. Our most recent project needed cross-continent logistics, with an apheresis center in Milwaukee and a manufacturing site in Prague. This long-standing partnership resulted in industry-leading transport times of 23 hours from the collection center (Milwaukee) to the manufacturing site (Prague) – against the client’s specification of 67 hours. #celltherapy #celltherapylogistics #supplychain #apheresis Christian Schenk

#ISCT24 did not disappoint! 🇸🇪 The networking and presentation quality were the perfect start to a busy second half of the year, here are a few things that stood out to us: 1️⃣ A (pleasantly) surprising amount of presentations and posters on MSCs, it seems they are well and truly back on stage! 2️⃣ Many regulatory sessions confirmed what we already recommend: early discussions with regulators is of great value 3️⃣ EMA will release new guidelines soon (see image below) and they are planning a symposium 'Contribution, evolution, revolution' on 10th October 2024 Also, a huge thanks to AstraZeneca and CCRM Nordic for a much-needed glass of wine and networking session to round off a brilliant few days in Gothenburg 🍷 If you have any follow-up questions about our presentation or didn't make it and want to find out more, please do get in touch!

Hello Gothenburg! 🇸🇪    We’re ready for ISCT Europe: lots of meetings, cutting-edge presentations, and the latest in the European CGT landscape.    Let's arrange a meeting if you’re heading to Gothenburg and want to find out how we can support preclinical and clinical development for your cell therapy and viral vectors programs.   We are more than just a regular CDMO – did you know we have a 150-strong apheresis network and proprietary logistics software? 🌍 👋 Feel free to connect with our CBO, Pascale Charbonnel on the ISCT Europe event app https://lnkd.in/dncpneb

How do you Increase Your Probability of Clinical Success When Translating from the Lab to GMP? As a therapy company-turned CDMO, we have a unique perspective from both sides of the fence. 🎙️Pascale Charbonnel, our CBO, will share some of these insights and experiences at #ISCT24   🗓️ Date: Wednesday, September 4th ⏰ Time: 10:15 – 10:30 📍Location: Room R17 – Global Showcase B From our experience, we believe the three top factors to set yourself up for clinical success: 1. 𝐆𝐌𝐏 𝐫𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬: what does it take to be GMP compliant? 2. 𝐂𝐨𝐧𝐬𝐢𝐬𝐭𝐞𝐧𝐭 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠: how can you consistently scale up and out to meet clinical dose requirements? What factors contribute to an all-inclusive budget? Are there shortcuts for translational success? 3. 𝐒𝐞𝐥𝐞𝐜𝐭𝐢𝐧𝐠 𝐲𝐨𝐮𝐫 𝐂𝐃𝐌𝐎 𝐩𝐚𝐫𝐭𝐧𝐞𝐫: what are the top criteria when selecting a CDMO partner More details of the agenda and presentation are at https://lnkd.in/eZFU33Fh Hope to see you ISCT, International Society for Cell & Gene Therapy Europe!🇸🇪

"We need more rapid sterility testing methods for frozen CAR-T drug products; here’s one potential approach..." Thanks to The Medicine Maker for their coverage of this rapid sterility testing method.