Shaping the Future of Cell Therapy Manufacturing, One Breakthrough at a Time.

Made Scientific and CARR Biosystems have partnered to bring CARR's UniFuge® single-use centrifugation to Made Scientific's Princeton and East Norriton facilities. Made Scientific will use UniFuge for cell harvest, wash, and concentration in 3D and large-scale manufacturing of mesenchymal stem cells (MSCs) and feeder…

Our team will be at Advanced Therapies USA in Boston next week. David Smith, Chathuranga De Silva Ph.D., Simona Jusyte, and Karen W. would love to hear where your program is headed, whether that's process development, scale-up, tech transfer, or GMP manufacturing. 📅 Book time with them before the show:…

Two things that tend to separate smooth GMP transitions from difficult ones: analytical readiness and process documentation. Analytical strategy drives how programs understand variability and defend consistency to regulators, from in-process monitoring and flow cytometry panels to potency assays and vector copy number…

Temperature can play an important role in making sterility testing more process-relevant for cell therapies. Growth-based compendial methods specify incubation around 20–25°C and 30–35°C. Cell therapy products are typically cultured at 37°C, and that difference can affect what organisms are recovered and how quickly…

How are AI, automation, and digitalization changing the way cell therapies get made? On Wednesday, Nov 4 at 5:10 PM ET, David Smith, Ph.D., VP & Head of Development, joins the panel "Advancing Cell Therapy Manufacturing: Embracing AI, Automation and Digitalisation" at Advanced Therapies USA. 📍 Join the session in the…

The build vs partner decision for MSCs is less philosophical than it sounds. It is really about where manufacturing risk lives over the next 24 to 48 months, and how much operational and regulatory load your team can absorb while the clinical program keeps moving. 🧭 At Made Scientific, we help teams map that risk to a…

A patient-centric R&D strategy needs a clear path to reliable manufacturing and patient access. Today at BioNJ's C-Suite Summit in Bridgewater, our Chairman & CEO Syed T. Husain joins the panel "Accelerating Patient-Centric Innovation in R&D" alongside Shobha Dhadda of Eisai US, Victoria Liang of Thermo Fisher…

Most T cell programs don't fail in GMP because the science was wrong. They fail because development decisions were made without manufacturing constraints in mind. The gap between a bench-scale protocol and a GMP-ready process is wider than it looks, and it usually shows up as comparability work, rework, or delays…

A cell that expresses the right surface markers is not necessarily a cell that does the right thing. That gap is where review questions tend to concentrate. It is also why potency is the hardest part of an iPSC analytical package, and the part most often deferred. Every iPSC-derived product has to answer a second…

Boston, we’ll see you in November! Made Scientific is proud to sponsor and exhibit at Advanced Therapies USA, November 4–5 at the Hynes Convention Center. We’re looking forward to connecting with the cell therapy community to discuss what it takes to move programs from development through commercial manufacturing. 📅…

Exosomes hold real promise. Making them consistently, at scale, is where the hard work is. Our Chairman & CEO, Syed T. Husain, sat down with @Yoram Drucker, Co-Founder and Chairman of NurExone Biologic (OTCQB:NRXBF) (TSXV: NRX) (FSE: J90), for NurExone's podcast on…

MSCs are helping patients because they take a different approach than traditional drug products, working through interaction and signaling in the body. That difference carries into manufacturing, where a stage-appropriate strategy starts with a workable process, then evolves into a scalable, controlled platform as the…

Choosing a cell therapy CDMO for an iPSC program means understanding how the work will run from cell banking through differentiation, manufacturing, and release. How closely do development and GMP teams work together? What does the analytical package include? How are multi-week manufacturing campaigns managed? Our…

Thank you to everyone who joined us at the Alliance for Regenerative Medicine's Meeting on the Mesa in Phoenix! David Smith, Ph.D., Chathuranga De Silva Ph.D., Simona Jusyte, and Karen W. spent time with developers advancing autologous and allogeneic programs, talking through what it takes to move from development and…

What if three early CAR-T manufacturing steps could become one? MadeFast™ is Made Scientific’s single-step CAR-T manufacturing platform concept, designed to consolidate T cell enrichment, activation, and transduction into a simpler early workflow. In a collaborative study with Syenex, RapidCell™ technology achieved up…