GMP viral vector manufacturing for gene therapy programs — AAV, lentiviral, and retroviral platforms. From process development and characterization through clinical and commercial-scale vector production.
Gene therapy is entering a commercial inflection point — 245 companies, 87 clinical stage, 7 approved products, 150+ active trials. Vector manufacturing capacity is the critical constraint. Made Scientific is investing in the vector manufacturing capacity and analytical capabilities that gene therapy developers need now.
From construct optimization through commercial-scale GMP production — every step needed to bring your gene therapy vector from bench to patient.
Upstream and downstream optimization — transfection, harvest, purification, and formulation — to maximize vector yield, purity, and potency for your specific construct.
Producer and packaging cell line development and banking — including suspension-adapted HEK293 lines for scalable AAV and lentiviral production.
GMP viral vector production in purpose-built suites — from bench-scale to 200L+ bioreactors with closed-system processing and full environmental monitoring.
Full vector characterization: titer (genome copies), potency (transduction, expression), identity (sequencing), purity (HCP, DNA), capsid ratio (AUC, CDMS), and safety (RCL/RCR).
Technology transfer from your development lab — including process comparability, scale-up studies, and engineering batch production.
IND-enabling and BLA-supporting manufacturing — including CMC documentation, comparability protocols, potency strategy, and regulatory filing support.
Both major gene therapy vector classes — AAV for in vivo delivery and lentiviral for ex vivo — with the process development depth to optimize for your specific program.
In vivo gene delivery
Ex vivo gene delivery
Our GMP facilities are designed specifically for cell and gene therapy and actively support concurrent programs across development stages.
Made Scientific Headquarters
Located at the heart of innovation in Princeton, New Jersey, our 60,000 ft² facility is equipped to take your therapy from early development to GMP manufacture.
Made Scientific Clinical Production
Strategically designed for flexibility, our Newark site offers 15,000 ft² of GMP-ready space to support client-dedicated and hybrid operational models.
Workforce Development & Training
We're investing in the future of cell therapy through both hands-on and digitally accessible GMP-inspired training. Located on the NJIT campus, our center has supported over 275 trainees across industry and academia.
Flexible engagement models for gene therapy programs at every stage.
All Clients
Full-service vector manufacturing in Made's GMP suites. From upstream production through purification and release — your team maintains oversight.
Mid-to-Late Stage Clients
Your scientists work alongside ours. Critical for complex vector programs where deep construct knowledge must transfer with the manufacturing process.
Late-Stage and Commercial Clients
Dedicated vector suites configured for your platform — from upstream bioreactor systems to downstream purification and analytical infrastructure.
Our scientists understand vector biology — not just manufacturing processes. From capsid engineering to tropism optimization, we bring scientific depth that accelerates process development.
Gene therapy demands the most sophisticated analytics in biologics. Our team develops the assays that characterize your vector completely — not just for release, but for process understanding.
Purpose-built GMP suites with bioreactor capacity up to 2000L. When your program succeeds, we have the capacity to manufacture at commercial scale — not a waitlist.
Segregated manufacturing suites support multiple vector programs simultaneously. Changeover and cleaning validation protocols ensure product safety across different vector types.
Have a question for our sales team? Contact us to explore how our expertise and capabilities can help you achieve your goals.
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