Your sterile
drug product, accelerated.
From formulation to CMC documentation in just 16 weeks.
Getting you clinical submission ready, with speed.
Our sterile manufacturing platform delivers liquid formulation in vials,
backed by Annex 1-aligned sterility assurance, designed to get your
sterile program to Phase I faster.
Securing small-scale sterile manufacturing capacity remains one of the most time-consuming and unpredictable stages of
development.
Traditional CDMO models typically require prolonged onboarding, internal queueing, multiple site interfaces and large amounts of internal red tape, all of which can lead to timelines of 6 months+ before a
complete CMC package is available.
Our platform is different. Speed, scale, and no surprises.
Every stage defined, every milestone fixed, every workstream sequenced to protect the endpoint. From molecule assessment at week one to final CMC documentation at week 16, the pathway is agreed before the science starts. What follows is execution, not estimation.
The 16-week timeline isn’t theoretical. It’s built on decades of delivering accelerated development in complex dosage forms, underpinned by more than 25 years of non-sterile formulation development and acceleration, where speed, precision, and risk mitigation are already embedded into how we work.
We don’t just define the pathway. We have the infrastructure, capability, and experience to deliver it.
Get to Phase I faster with an Annex 1 aligned sterile facility.
Dedicated 7,000 sq. ft sterile manufacturing facility with integrated R&D and QC laboratories.
- Flexible aseptic processing and fill/finish processes
- Rapid transfer three chamber solid wall VHP isolator technology
- Liquid in 2R – 20R vials
- Advanced contamination
control strategies