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Extracellular vesicles have been studied as messengers between cells for decades. What has changed is the recognition that this biology can be harnessed therapeutically. EVs can be engineered, loaded, and scaled as drug products. They are biocompatible by nature, non-replicating unlike viral vectors, and capable of carrying diverse molecular cargo across biological barriers. The science is compelling. The manufacturing path to the clinic is not simple. The three hardest problems in EV development right now: 1️⃣ Cell source variability. The producing cell determines everything downstream. Process decisions made early - adherent vs. suspension, shake flask vs. bioreactor - compound at scale. 2️⃣ Purification complexity. EVs coexist with debris, protein aggregates, and non-vesicular particles. Building a purification train that is efficient at bench scale and translatable to GMP is non-trivial. 3️⃣ Analytical limitations. No single instrument reliably measures size, concentration, and surface marker identity simultaneously. Our team addressed this directly - demonstrating that conventional flow cytometry with VSSC configuration can quantify EVs at 100 nm with a %CV of 3.77%, applicable to real-time process monitoring and lot release. At Landmark Bio, our EV capabilities span the full development path: upstream production across iMSC, MSC, HSC, and HEK293T cell types; adherent and suspension workflows with bioreactor scale-up; downstream purification from clarification through formulation; and a full analytical panel covering titer, potency, identity, purity, quality, and safety. The new Landmark Lens post covers the science, the manufacturing challenges, and how we approach them. ➡️https://lnkd.in/eQJCvSKb #LandmarkBio #ExtracellularVesicles #EV #NonViralDelivery #CellTherapy #GMP #AdvancedTherapies

New Landmark Lens Q&A 💡💡 Early CMC strategy is one of the biggest predictors of success for advanced therapy programs — yet it’s also one of the most common sources of avoidable setbacks. In our latest blog, Landmark Bio experts Gregg Nyberg and Michael Covington unpack the early signals that teams should pay attention to, how to align analytics and process sooner, and what regulators want to see well before IND. Their key message: when CMC decisions are integrated from day one, development moves with more clarity, stronger data, and fewer surprises. 🔗 Read the full Q&A: https://hubs.la/Q03WNqyj0 #AdvancedTherapies #CMC #CGT SmarterFasterIND

🚀 Introducing The Landmark Lens: a new blog exploring how science, process, and purpose converge to advance next-generation therapies. Our first article takes you inside the engine behind our CAR-T capabilities: how fully integrated teams, mirrored development-to-GMP systems, and true scientific collaboration keep programs moving without losing time or data fidelity. When every function lives under one roof, it’s not just faster... it’s smarter, more connected manufacturing that keeps therapies on track to reach patients sooner. Read the full post: https://hubs.la/Q03S_tKK0 #CART #CellTherapy #GeneTherapy #CDMO #AdvancedTherapies #Biotech #Manufacturing #Innovation

What sets Landmark Bio apart in cell and gene therapy, allowing innovators to bring transformative treatments to patients faster? 🔹 Multiple Modalities Under One Roof From cell therapy to viral vector manufacturing, we integrate technologies critical for CGT production. This unique model means fewer handoffs, streamlined timelines, and a smoother path to the clinic. 🔹 Nimble, Flexible, Fast For one of our CAR-T partners, we initiated a custom tech transfer in just 2 weeks, completed the first engineering run in 3 months, and have since produced 45+ GMP lots — accelerating their program toward patients. With deep expertise, integrated capabilities, and a commitment to collaboration, Landmark Bio is building the infrastructure to make advanced therapies a reality. 📩 Interested in learning how we can support your program? Let’s connect: https://hubs.la/Q03KKCsS0 #CellTherapy #CART #CGT #GMPManufacturing #Biotech #LandmarkBio

Facility Feature: Inside Our cGMP Suites at Landmark Bio 🔬 📍Located in Watertown, MA, our 44,000 sq ft integrated facility brings together development, manufacturing, and QC under one roof—eliminating handoffs, reducing delays, and supporting end-to-end product evolution. Why it matters: These suites are modular and future-ready—designed to adapt to evolving therapeutic modalities while maintaining rigorous quality standards. Independent HVAC, segregated flows, and digital monitoring ensure compliance and reliability, enabling faster transitions from development to GMP. With these capabilities, we help partners move from idea to IND—and from first patient to scale—with greater speed, confidence, and control. Cell and gene therapies demand precision, agility, and infrastructure built for complexity. That’s exactly what we’ve created. Explore the full facility: https://hubs.la/Q03xptch0 #LandmarkBio #GMPManufacturing #CGT #ArtisBioSolutions #BostonBiotech

Translating an R&D breakthrough into a viable therapeutic is rarely straightforward. In this on-demand webinar, Landmark Bio leaders share how to navigate CMC and regulatory complexity, streamline tech transfer, and accelerate time to clinic for advanced therapies. Watch now and gain insights into strategies that help innovators overcome key manufacturing hurdles in cell and gene therapy.