Kymanox

When a client partnership becomes a true team integration 💙 We're proud to share these words from the Head of Device Development at a leading European biotechnology company: “𝘞𝘩𝘦𝘯 𝘐 𝘢𝘳𝘳𝘪𝘷𝘦𝘥, 𝘸𝘦 𝘩𝘢𝘥 𝘯𝘰 𝘋𝘦𝘴𝘪𝘨𝘯 𝘏𝘪𝘴𝘵𝘰𝘳𝘺 𝘍𝘪𝘭𝘦, 𝘯𝘰 𝘵𝘦𝘮𝘱𝘭𝘢𝘵𝘦𝘴, 𝘯𝘰 𝘥𝘦𝘷𝘪𝘤𝘦 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘦𝘹𝘱𝘦𝘳𝘵𝘪𝘴𝘦, 𝘢𝘯𝘥 𝘯𝘰 𝘥𝘦𝘴𝘪𝘨𝘯 𝘤𝘰𝘯𝘵𝘳𝘰𝘭 𝘧𝘳𝘢𝘮𝘦𝘸𝘰𝘳𝘬. 𝘞𝘦 𝘣𝘶𝘪𝘭𝘵 𝘦𝘷𝘦𝘳𝘺𝘵𝘩𝘪𝘯𝘨 𝘧𝘳𝘰𝘮 𝘻𝘦𝘳𝘰 — 𝘢𝘯𝘥 𝘒𝘺𝘮𝘢𝘯𝘰𝘹 𝘸𝘢𝘴 𝘵𝘩𝘦 𝘵𝘦𝘢𝘮 𝘵𝘩𝘢𝘵 𝘮𝘢𝘥𝘦 𝘪𝘵 𝘱𝘰𝘴𝘴𝘪𝘣𝘭𝘦. 𝘛𝘩𝘦𝘺 𝘤𝘳𝘦𝘢𝘵𝘦𝘥 𝘵𝘩𝘦 𝘦𝘯𝘵𝘪𝘳𝘦 𝘋𝘏𝘍 𝘴𝘵𝘳𝘶𝘤𝘵𝘶𝘳𝘦 𝘸𝘪𝘵𝘩 𝘶𝘴, 𝘪𝘮𝘱𝘭𝘦𝘮𝘦𝘯𝘵𝘦𝘥 𝘥𝘦𝘴𝘪𝘨𝘯 𝘤𝘰𝘯𝘵𝘳𝘰𝘭𝘴, 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘦𝘥 𝘳𝘦𝘶𝘴𝘢𝘣𝘭𝘦 𝘵𝘦𝘮𝘱𝘭𝘢𝘵𝘦𝘴, 𝘦𝘴𝘵𝘢𝘣𝘭𝘪𝘴𝘩𝘦𝘥 𝘚𝘖𝘗𝘴, 𝘢𝘯𝘥 𝘵𝘳𝘢𝘯𝘴𝘧𝘦𝘳𝘳𝘦𝘥 𝘵𝘩𝘦 𝘬𝘯𝘰𝘸𝘭𝘦𝘥𝘨𝘦 𝘸𝘦 𝘯𝘦𝘦𝘥𝘦𝘥 𝘵𝘰 𝘳𝘶𝘯 𝘢 𝘤𝘰𝘮𝘱𝘭𝘪𝘢𝘯𝘵 𝘱𝘳𝘰𝘨𝘳𝘢𝘮. 𝘈𝘯𝘥 𝘵𝘩𝘦 𝘷𝘢𝘭𝘪𝘥𝘢𝘵𝘪𝘰𝘯 𝘸𝘢𝘴 𝘶𝘯𝘥𝘦𝘯𝘪𝘢𝘣𝘭𝘦: 𝘥𝘶𝘳𝘪𝘯𝘨 𝘢𝘯 𝘦𝘹𝘵𝘦𝘳𝘯𝘢𝘭 𝘳𝘦𝘷𝘪𝘦𝘸, 𝘢 𝘩𝘪𝘨𝘩𝘭𝘺 𝘳𝘦𝘴𝘱𝘦𝘤𝘵𝘦𝘥 𝘨𝘭𝘰𝘣𝘢𝘭 𝘥𝘦𝘷𝘪𝘤𝘦 𝘰𝘳𝘨𝘢𝘯𝘪𝘻𝘢𝘵𝘪𝘰𝘯 𝘥𝘦𝘴𝘤𝘳𝘪𝘣𝘦𝘥 𝘰𝘶𝘳 𝘋𝘏𝘍 𝘢𝘴 𝘧𝘭𝘢𝘸𝘭𝘦𝘴𝘴. 𝘍𝘰𝘳 𝘢 𝘱𝘳𝘰𝘨𝘳𝘢𝘮 𝘵𝘩𝘢𝘵 𝘴𝘵𝘢𝘳𝘵𝘦𝘥 𝘧𝘳𝘰𝘮 𝘯𝘰𝘵𝘩𝘪𝘯𝘨, 𝘵𝘩𝘢𝘵 𝘮𝘦𝘢𝘯𝘵 𝘦𝘷𝘦𝘳𝘺𝘵𝘩𝘪𝘯𝘨.” This is what partnership looks like to us: deep expertise, practical execution, and building the foundations that help life-changing products reach patients safely. ------------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

Thank You for Helping Us Reach 100%. We’re thrilled to share that the Kymanox CARES team has officially reached 100% of our food drive goals — both physical and virtual. Your generosity this season has been remarkable, and it’s already making a meaningful difference for families in our communities. This year, it was especially important to come together and support those who rely on community resources to meet their daily needs. Thanks to your commitment, we were able to amplify our impact across multiple partners: • Philabundance: 100% funded through the Kymanox CARES Virtual Food Drive • World Central Kitchen: 100% funded through our team’s fundraising page Your contributions — whether through donations, sharing the initiative, or encouraging others to join — reflect the true spirit of Kymanox CARES. While we’ve met our goal, we hope the momentum keeps going. If you’re able, we encourage you to continue supporting your local food banks and hunger relief organizations. Even a small gesture can make a big difference. Thank you for helping us stand alongside our communities and for demonstrating what it means to lead with compassion. Together, we’re making an impact that matters.

How do you sterilize a product that can’t tolerate the heat? A client came to us with a temperature-sensitive formulation that couldn’t withstand a standard steam sterilization cycle. Our team stepped in to help them understand the sterilization landscape, explore alternative cycle designs, and map out what was scientifically possible. Instead of continuing trial-and-error runs, we built a predictive model that revealed how the product degraded across time and temperature. The insight allowed us to redesign the sterilization cycle—achieving microbiological inactivation and protecting the product. The Outcome: ✔️ A commercially viable sterilization process for both vials and PFS ✔️ A Quality-by-Design framework the client can rely on as they scale ✔️ Greater confidence in product quality and process robustness If sterilization is slowing down your path to market, you don’t have to go it alone. 🔗 https://lnkd.in/e4MQC49p ------------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

This December, connect with our experts at two leading global drug delivery conferences: #CNS Drug Delivery Summit and #DDL 2025. 𝗖𝗡𝗦 𝗗𝗿𝘂𝗴 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗦𝘂𝗺𝗺𝗶𝘁 – Meet our team in Boston from 09–11 DEC as we join the industry’s premier forum advancing CNS drug delivery across routes, modalities, and indications. Connect with Stefanie Hurowitz and Khristian Rivera onsite to explore how Kymanox supports programs from early formulation through validation and regulatory submission. 𝗗𝗗𝗟 𝟮𝟬𝟮𝟱 – Visit us at Booth #144 in Edinburgh from 10–12 DEC. DDL enters its 36th year as one of the world’s leading gatherings for inhalation science and innovation. Stop by our booth to meet Sian Eden and Thierry Jomini and learn how our design, development, and testing services help advance safe, effective, and reliable respiratory combination products. 👋 Stop by to say hello, connect with our experts, and discover how Kymanox continues to lead in drug delivery innovation, reliability, and combination product excellence. Follow us to stay connected with where our team will be next. ------------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

In complex device and combination-product development, the right partners make all the difference, especially when you’re balancing design feasibility, technical risk, and clinical or commercial timelines. That’s why feedback like this means so much to our team: “𝘛𝘩𝘦 𝘒𝘺𝘮𝘢𝘯𝘰𝘹 𝘵𝘦𝘢𝘮 𝘪𝘴 𝘵𝘳𝘶𝘴𝘵𝘸𝘰𝘳𝘵𝘩𝘺, 𝘳𝘦𝘭𝘪𝘢𝘣𝘭𝘦, 𝘢𝘯𝘥 𝘤𝘰𝘮𝘱𝘦𝘵𝘦𝘯𝘵. 𝘐𝘵’𝘴 𝘷𝘦𝘳𝘺 𝘦𝘢𝘴𝘺 𝘵𝘰 𝘦𝘯𝘨𝘢𝘨𝘦 𝘸𝘪𝘵𝘩 𝘵𝘩𝘦𝘮 𝘢𝘴 𝘢 𝘴𝘵𝘳𝘢𝘵𝘦𝘨𝘪𝘤 𝘱𝘢𝘳𝘵𝘯𝘦𝘳, 𝘢𝘯𝘥 𝘵𝘩𝘦𝘺 𝘩𝘢𝘷𝘦 𝘢 𝘭𝘰𝘵 𝘰𝘧 𝘨𝘰𝘰𝘥 𝘳𝘦𝘴𝘰𝘶𝘳𝘤𝘦𝘴. 𝘛𝘩𝘦𝘺 𝘷𝘦𝘵 𝘵𝘩𝘦𝘪𝘳 𝘤𝘢𝘯𝘥𝘪𝘥𝘢𝘵𝘦𝘴 𝘷𝘦𝘳𝘺 𝘸𝘦𝘭𝘭, 𝘴𝘰 𝘸𝘦 𝘬𝘯𝘰𝘸 𝘵𝘩𝘦𝘺 𝘸𝘪𝘭𝘭 𝘥𝘦𝘭𝘪𝘷𝘦𝘳 𝘸𝘩𝘦𝘯 𝘵𝘩𝘦𝘺 𝘤𝘰𝘮𝘦 𝘰𝘯 𝘢 𝘱𝘳𝘰𝘫𝘦𝘤𝘵 𝘸𝘪𝘵𝘩 𝘶𝘴. 𝘈𝘯𝘥 𝘪𝘧 𝘸𝘦 𝘯𝘦𝘦𝘥 𝘢𝘥𝘥𝘪𝘵𝘪𝘰𝘯𝘢𝘭 𝘩𝘦𝘭𝘱 𝘪𝘯 𝘢𝘯 𝘢𝘳𝘦𝘢 𝘵𝘩𝘢𝘵 𝘰𝘶𝘳 𝘵𝘦𝘢𝘮 𝘪𝘴 𝘯𝘰𝘵 𝘧𝘢𝘮𝘪𝘭𝘪𝘢𝘳 𝘸𝘪𝘵𝘩, 𝘵𝘩𝘦𝘺 𝘩𝘢𝘷𝘦 𝘴𝘰𝘮𝘦𝘰𝘯𝘦 𝘪𝘯 𝘵𝘩𝘢𝘵 𝘨𝘳𝘰𝘶𝘱 𝘵𝘩𝘢𝘵 𝘸𝘦 𝘤𝘢𝘯 𝘢𝘤𝘤𝘦𝘴𝘴 𝘵𝘰 𝘢𝘴𝘬 𝘲𝘶𝘦𝘴𝘵𝘪𝘰𝘯𝘴.” — 𝗗𝗲𝘃𝗶𝗰𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗟𝗲𝗮𝗱, 𝗚𝗹𝗼𝗯𝗮𝗹 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗖𝗼𝗺𝗽𝗮𝗻𝘆 For us, great device development isn’t just about engineering excellence, it’s about collaboration, communication, and helping teams move forward with confidence. If you’d like insights on reducing risk or accelerating timelines in your next device project, our team is always happy to share what we’re seeing across the industry. Get in touch: https://lnkd.in/eVUeKjwJ ------------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

Drug-device development moves faster when everything you need is in one place. Our 5,000 sq. ft. Device Lab includes: • Maker space for rapid prototyping • Clinical GMP lab for small-batch assembly • Usability studio for human factors testing With 300+ products supported, our cross-functional teams help programs reduce risk, improve reliability, and reach their next milestone with confidence. Whether you’re facing a design challenge or need to scale into testing and assembly—Kymanox can help. https://lnkd.in/eVUeKjwJ ------------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

At Kymanox, we don’t think of ourselves as consultants. We provide professional services and to us, that means something more. We don’t simply give advice. We partner with you, own the process alongside you, and take accountability for results. After 20 years supporting teams across the life sciences, we’ve seen similar challenges surface again and again: 🔹 Siloed functions 🔹 Limited collaboration 🔹 Misaligned requirements We help teams create alignment across Design, Quality, Regulatory, Operations, and beyond—so you can bring therapies to market safely, efficiently, and with confidence. Because we’re in the professional services business, 𝘆𝗼𝘂𝗿 𝘀𝘂𝗰𝗰𝗲𝘀𝘀 𝗶𝘀 𝗼𝘂𝗿 𝗼𝗻𝗹𝘆 𝗺𝗲𝗮𝘀𝘂𝗿𝗲. Our cross-functional team of SMEs plug in when you’re short on bandwidth, expertise, or both. Let’s solve the hard puzzles together. Learn more at https://lnkd.in/eVUeKjwJ ------------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

Happy Thanksgiving from Kymanox! At Kymanox, gratitude isn’t just a seasonal message — it’s one of our core values. Today, we’re especially thankful for the clients, partners, and colleagues who allow us to play a role in advancing life-changing therapies and technologies. Your collaboration fuels our mission to help bring safer, better, and more efficient solutions to patients around the world. We are grateful for the trust you place in our team and for the shared commitment to improving lives. Wishing you and your loved ones a warm, restorative, and meaningful holiday. — The Kymanox Team

A Smarter Approach to Design Controls—Powered by AI. Product development teams are under pressure to move faster, reduce risk, and maintain compliance. AI is emerging as a force multiplier—if used responsibly. In this conversation, Kymanox CTO Nicholas Ciccarelli explains how AI can help teams: ✔ Analyze verification data more efficiently ✔ Scan FDA communications for emerging trends ✔ Improve consistency across documentation ✔ Shorten development cycles without adding compliance risk He also discusses the hidden energy cost of AI—and what that means for sustainable device development. Listen to the full discussion: https://lnkd.in/ekbPsqt7 Hosted by: Chris Adkins ------------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

𝗞𝗲𝘆 𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗔𝗙𝗗𝗢 𝗥𝗔𝗣𝗦 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀 𝗦𝘂𝗺𝗺𝗶𝘁 Our team spent two days diving into the latest regulatory thinking from FDA and industry leaders. Three themes stood out across conversations, workshops, and case studies: 🔹 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗗𝗿𝘂𝗴 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗢𝘂𝘁𝗽𝘂𝘁𝘀 (𝗘𝗗𝗗𝗢𝘀) The FDA’s draft guidance is pushing teams to define clearer dose-delivery outputs and smarter control strategies. Expect revisions as industry highlights gaps and inconsistencies. Read our blog: https://lnkd.in/eH5z-Qnb 🔹 𝗚𝗹𝗼𝗯𝗮𝗹 𝗛𝗮𝗿𝗺𝗼𝗻𝗶𝘇𝗮𝘁𝗶𝗼𝗻 A consistent message: combination product teams need a global strategy early. In Europe, drug and device components often follow separate regulatory routes, which can misalign timelines, data expectations, and documentation when compared with U.S. pathways. Better coordination upfront can reduce friction across markets. 🔹 𝗟𝗲𝘃𝗲𝗿𝗮𝗴𝗶𝗻𝗴 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵𝗲𝘀 Platform strategies and clinical bridging continue to grow in importance. By building on approved device platforms and existing vial-and-syringe clinical data, sponsors can sometimes avoid repeating costly PK bioequivalence studies—especially when the main change is the active ingredient. These risk-based approaches help meet safety and usability expectations while shortening development timelines. Read our blog: https://lnkd.in/ech5BNPR Always energizing to see how the field is evolving—and how industry, FDA, and sponsors are working together to streamline combination product development. ------------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv