Removing barriers in genomic medicine and targeted delivery
Your idea needs a hands‑on partner to reach the clinic faster.
Getting your program from concept to GMP manufacturing for clinical Phase I and II takes the right process, the right data, and the right people. That’s what we bring: hands-on experience, real partnership, and the expertise to bring it all together.
Built by Scientists, Backed by a Global Network
GaletaBio was founded by scientists with decades of experience in viral and non-viral delivery systems, diverse therapeutic cargo, scalable production methods, and advanced analytical characterization – so you can move from concept to clinic faster, with fewer delays and more confidence in your data.
Our Services
From Start-Up to Established Biotech, We Work for Your Success
Whether you’re a small team or an established biotech, you need the same foundations: solid CMC, well-characterized processes, and analytical methods built to keep pace. That’s where we come in.
We want your drug to do more than meet regulatory requirements: safer, more effective, higher quality. That’s what novel analytical methods and predictive biology systems make possible: de-risking early development, supporting efficacy predictions, and optimizing drug product design and formulation from the start. And the process stays yours: no IP lock-in, ever.
Early De-Risking & Material Screening
Most costly problems start in the early stages: a material interaction, a container closure issue, an early stability indicator. We catch these before formulation even starts, saving you the time and money of costly downstream troubleshooting.
Drug Design and Formulation
We use predictive biology system to help validate potential efficacy and optimize drug product design from the start.
Process Development
With decades of experience, we have already solved PD issues across viral and non viral delivery systems, diverse therapeutic cargos, and production methodologies. The result: robust, scalable processes that enable high purity, high yield production and fewer surprises when you move to GMP scale.
Analytical Development
We bring advanced analytical capabilities to characterize your product and process in depth, from potency and identity to critical impurities and stability. This gives you the data package you need to satisfy regulatory expectations and make confident decisions about scale up and clinical progression.
Tech Transfer
The transition to manufacturing is where many programs stall. Our R&D and GMP teams work side-by-side to completely de-risk your technology transfer. We define precise, data-backed in-process controls (IPCs) on the floor, ensuring the process remains exactly the same in the GMP suite as it was in the lab.
GMP Manufacturing
We support your move from development to Phase I–II GMP manufacturing in our own GMP facilities, backed by QA, QC, and R&D teams. We help innovators, developers, and investors de-risk tech transfer, align CMC strategy with clinical plans, and keep the path to the clinic moving on schedule.
how we support you
Whether you’re an early-stage startup or a large biotech,
we are here to support you.
Unlike traditional CDMOs, we’re agile and flexible enough to adapt quickly to your requirements as they evolve. With our in-depth analytical knowledge and novel analytical technologies, we catch impurities others might miss. We secure your bioprocess integrity with future’s stricter criteria in mind. We take confidentiality and intelectual property seriously. Our main focus is solving your technical CMC challenges and getting your therapy to the clinic. You retain full, unrestricted ownership of your drug product and the processes we develop for you. We are here to be your trusted development partner, not your co-owner.
Large biotech
get an extension of their team, not just advice. We’ll fill the gaps where you lack time or capacity. With our global network, we connect you to the right people, and help you spot the innovation happening in small, specialized companies that might be flying under your radar.
Smaller teams
get a partner who works to bring their science to investors and to market, as fast as possible and with less risk. Our support goes beyond the lab: we understand the funding challenges and regulatory hurdles that come with getting a drug product to production. We use our experience to translate your academic innovation into practical, scalable GMP processes, solving complex challenges with real-world data.
