Verified Process Fit
We do not bend your process to fit our line — we verify the fit, then hold to it.
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Most contract manufacturers have a standard way of running things, and a client process gets quietly adjusted until it fits. That adjustment is where early-phase material goes missing, and where the batch stops matching the process described in your filing. We work the other way. During tech transfer we establish by measurement whether your process runs on our line, report what we find in full, and leave process decisions with you. Where our equipment requires a change, it is proposed, documented and approved before execution — never assumed.
Photos of GMP facility at OmniParticles
What we offer
1
Tech transfer with documented process fit assessment and batch record preparation
Establish process fit by measurement during tech transfer, and report findings in full rather than adjusting quietly.
2
Change control on any deviation from your defined process
Leave process decisions with you — any change our equipment requires is proposed, documented and approved before execution.
3
Low hold-up-volume single-use line design
Protect scarce drug substance through low hold-up-volume single-use line design, minimizing material lost to the line.
4
Filterability confirmation and characterization
Filterability confirmation — pre- and post-filtration comparison. Particle and material characterization to support transfer and release: DLS, TEM, zeta-potential; HPLC (including SEC mode, triple detector); UV-Vis, ICP-MS where required. In-process controls and release checks run with your methods, or established methods where you specify them.
5
Complex formulations assessed, not declined
Assess formulations that fall outside a standard fill-finish envelope — suspensions, colloidal systems, viscous products, light- or oxygen-sensitive products — rather than declining them on sight. Colloidal and nanoparticle suspensions are routine work here, drawn from our drug substance operations, so a formulation that would be an unknown elsewhere is assessed instead of refused.