Kymanox

What do investors really look for in #biotech startups? Dave Ousterout, PhD, Co-Founder & General Partner at Cape Fear BioCapital, emphasizes that operational talent is key. Startups need project management that keeps them on track—because every day matters. In our latest episode of 𝘓𝘪𝘧𝘦 𝘚𝘤𝘪𝘦𝘯𝘤𝘦 𝘚𝘰𝘭𝘶𝘵𝘪𝘰𝘯𝘴, Dave shares what sets high-potential startups apart—and it’s not just great #science. Operational discipline, execution bias, and knowing how to keep momentum daily are non-negotiables. 𝗟𝗶𝘀𝘁𝗲𝗻 𝗻𝗼𝘄 𝘁𝗼 𝗵𝗲𝗮𝗿 𝗗𝗮𝘃𝗲’𝘀 𝘁𝗮𝗸𝗲 𝗼𝗻: • Why strong operations win investor confidence • How to build teams that move with urgency and balance • What makes North Carolina a unique launchpad for innovation 🎙️ Stream the episode and tag someone who needs to hear this! https://lnkd.in/e2-Uq2Pc Hosted by: Chris Adkins At Kymanox, we help startups deliver on that promise. With deep expertise in #projectmanagement, #regulatory strategy, and technical operations, our teams keep innovators on track—so no day is lost and every step moves you closer to the patient. #lifescience #investment 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

Celebrating Earth Day. 🌱 At Kymanox, we believe building a healthier world starts with the choices we make—both in the lab and in the workplace. From reducing landfill waste through composting, to cutting down on single-use plastics with refillable water stations, we’re taking steps to build sustainability into our everyday operations. This month, our team is also gearing up to give back by planting trees in our local community as part of our ongoing commitment to environmental stewardship. #earthday --------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

𝗦𝗽𝗿𝗶𝗻𝗴 𝗯𝗶𝗼𝘁𝗲𝗰𝗵 𝗲𝘃𝗲𝗻𝘁𝘀 𝗮𝗿𝗲 𝗵𝗲𝗿𝗲—𝘄𝗶𝗹𝗹 𝘄𝗲 𝘀𝗲𝗲 𝘆𝗼𝘂 𝘁𝗵𝗲𝗿𝗲? If you’re attending either event, let us know—we’d love to meet up and hear what you're working on. 𝟬𝟱–𝟬𝟲 𝗠𝗮𝘆: Swiss Biotech Day 2025 (Basel, Switzerland) Meet Sian Eden and Thierry Jomini at one of Europe's leading biotechnology conferences. Discover how Kymanox is helping drive innovation through strategic collaboration, regulatory expertise, and end-to-end product development support. #SwissBiotechDay #GlobalBiotech #BiotechInnovation 𝟬𝟳–𝟭𝟬 𝗠𝗮𝘆: ASGCT 27th Annual Meeting (New Orleans, LA) We're excited to attend the #ASGCT2025 Annual Meeting. Meet our team—Jessica Gove, PhD, Nathan B., and Roger Lias—to explore how Kymanox supports #CGT innovators from development through commercialization. #CellTherapy #GeneTherapy A big thank you to everyone who stopped by our booth at PDA Week 2025 and entered the raffle. Congratulations to Mihaela Carmen Simianu, Ph.D, the winner of our iPad giveaway! Follow us to stay up to date on upcoming conferences. --------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

Continued Process Verification (#CPV) is not just a best practice – it's an #FDA requirement. Our Vice President of Technical Services, Ryan M. Doxey, and Senior Process Engineer, Anthony Stewart, shared practical insights at #PDAWeek2025 on how to build a compliant, effective Continued Process Verification (CPV) program that supports product success throughout the lifecycle. 𝗧𝗵𝗲 𝘀𝗲𝘀𝘀𝗶𝗼𝗻 𝗰𝗼𝘃𝗲𝗿𝗲𝗱 𝘀𝗲𝘃𝗲𝗿𝗮𝗹 𝗸𝗲𝘆 𝘁𝗼𝗽𝗶𝗰𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴: • Why CPV matters for post-market compliance • A phased approach for legacy & new products • Lessons learned from real-world implementation Explore highlights from our poster presentation: "Implementation of a Continued Process Verification Program for Post-Market Compliance & Product Success" here: https://lnkd.in/eVYQBd75 #ContinuedProcessVerification #biologics #quality --------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

During times of regulatory transition, Kymanox remains your steady partner. We understand change may create uncertainty for your development timelines and submission strategies, but our commitment to our clients is to provide stability, consistency, and clear guidance aligned with current regulatory requirements. Our strategy includes proactive preparation for emerging regulatory requirements and expectations that may reshape industry standards. For over two decades, we've successfully navigated numerous regulatory shifts. Our team includes former FDA reviewers and industry veterans who understand both current requirements and where standards are heading. We bring institutional knowledge that can support your goals in the development journey, all while navigating the regulatory path forward. #Regulatory #MedTech #Biotech #FDA --------- 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 this special episode recorded live at CED (Center for Entrepreneurial Development) Venture Connect, host Chris Adkins sits down with Dave Ousterout, PhD, Co-Founder and General Partner at Cape Fear BioCapital. Drawing from his unique journey as both a #biotech entrepreneur and now a venture capital investor, Dave shares what it really takes to stand out in the early-stage life sciences space. Listeners get a behind-the-scenes look at how Cape Fear BioCapital is fueling North Carolina’s innovation ecosystem with pre-seed investments tailored for biotech startups. Subscribe to get a first listen: https://lnkd.in/e939RH3Q #podcast #LifeScience #Venturecapital --------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

Many pharma companies struggle with the transition from investigational to market-ready combination products, often resulting in costly delays and unexpected regulatory hurdles. Our latest article, "Clinical Phase-Appropriate Combination Product Development And Seamless Transition To Commercialization," written by Anna Jackson, M.S., PMP, tackles this industry-wide challenge head-on. Anna breaks down how to strategically select delivery systems that balance clinical needs with commercial viability: 🔹 The critical differences between container closure systems across clinical phases 🔹 Why early-phase decisions dramatically impact late-stage development costs 🔹 Practical strategies to bridge between delivery technologies without derailing your timeline Stop the costly cycle of rework and redesign. Learn how to develop a phase-appropriate strategy that keeps your combination product program on track from clinic to market. Contact our experts today for support. Read the full article: https://lnkd.in/e5uzFWDG First published in: PharmaOnline & Cell & Gene #DrugDelivery #CombinationProducts --------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

Join Kymanox experts at key industry events this spring! Discover how our solutions can help you get more done. 📅 𝟮𝟱 𝗔𝗽𝗿𝗶𝗹: 𝗕𝗣𝗗 𝟮𝟬𝟮𝟱 𝗖𝗲𝗹𝗹 & 𝗚𝗲𝗻𝗲 𝗧𝗵𝗲𝗿𝗮𝗽𝘆 𝗦𝘆𝗺𝗽𝗼𝘀𝗶𝘂𝗺 (𝗖𝗵𝗮𝗽𝗲𝗹 𝗛𝗶𝗹𝗹, 𝗡𝗖) Kymanox is proud to be a platinum sponsor for this year’s Cell & Gene Therapy Symposium. We are looking forward to joining the local North Carolina network. Meet our team onsite: Anthony Winner Chris Adkins Ciony Kim Jordan Bischoff, MMB, Kyle Arend, PhD, LeAnne Adkins, Mark Hagerty, Nicole Bridgers, & Ryan M. Doxey #NCBiotech #CellAndGeneTherapy #CGT #Biotech #BPDCGT2025 📅 𝟮𝟴-𝟯𝟬 𝗔𝗽𝗿𝗶𝗹: 𝗣𝗿𝗲-𝗙𝗶𝗹𝗹𝗲𝗱 𝗦𝘆𝗿𝗶𝗻𝗴𝗲𝘀 & 𝗜𝗻𝗷𝗲𝗰𝘁𝗮𝗯𝗹𝗲 𝗗𝗿𝘂𝗴 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 (𝗕𝗼𝘀𝘁𝗼𝗻, 𝗠𝗔) SAE Media Group 2th Annual Pre-Filled Syringes and Injectable Drug Devices East Coast Conference returns bigger than ever with a 3-day program featuring pre-conference focus day, keynote plenaries, and specialized afternoon streams. Meet our team, Jessica Gove, PhD & Taras Seniuch, at our booth #P446 to explore injectable device innovations and combination product solutions! #PFSBoston2025 #PFS #DrugDelivery #CombinationProducts #PreFilledSyringes 📅 𝟬𝟱-𝟬𝟲 𝗠𝗮𝘆: 𝗦𝘄𝗶𝘀𝘀 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗗𝗮𝘆 𝟮𝟬𝟮𝟱 (𝗕𝗮𝘀𝗲𝗹, 𝗦𝘄𝗶𝘁𝘇𝗲𝗿𝗹𝗮𝗻𝗱) Connect with Sian Eden and Thierry Jomini at this premier global biotechnology conference that attracted 2,500+ participants from over 40 countries last year. Explore advances in R&D, manufacturing, data management, AI, and innovative financing while strengthening international partnerships. #SwissBiotechDay Our experts are ready to discuss your challenges and showcase Kymanox solutions. Which events will you be attending? Let us know! --------- 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 February, the Kymanox CARES Boston Team spent an evening volunteering at My Brother’s Table in Lynn, MA—the largest soup kitchen on the North Shore. Since 1982, My Brother’s Table has served over 3,000 free meals monthly, providing nourishment without question. Our team helped prepare and serve meals, assemble bag lunches, and proudly presented an $8,000 donation through the Kymanox CARES initiative. At Kymanox, we’re committed to supporting organizations that bring dignity, compassion, and connection to our communities.💜 --------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv

Meet Our Sterilization Engineering Team. Our team brings unparalleled expertise to ensure your medical products meet the highest standards of sterility. With specialized certifications and decades of combined experience, our team provides innovative solutions to complex sterilization challenges. Shaun Devitt, CISS-EO, CISS-RAD is our Director of Sterilization Engineering and has 10+ years in medical device sterilization. Shaun specializes in both conventional methods (e.g., steam, radiation, EO) and innovative approaches (e.g., H2O2, NO2, UV). His practical solutions consistently meet stringent regulatory requirements while solving complex sterility challenges. Josh Earp, CISS-RAD is our Senior Engineer who brings radiation sterilization expertise with impressive credentials: 100+ qualified products, facility qualification experience, and specialized knowledge in dosimetric testing, environmental monitoring, and ISO 17025 compliance. Contact us to ensure your products meet the highest sterility standards. #sterilizationengineering --------- 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐊𝐲𝐦𝐚𝐧𝐨𝐱: Follow Us: https://lnkd.in/e35y_dQq Get in Touch: www.kymanox.com Subscribe: https://lnkd.in/eYDXYarv