Services

Everything you need from discovery to first-in-human, under one roof.

Fixed-scope packages — mAb Preclinical, mAb Clinical/IND, Gene Vector, Viral Vector — designed to take your program from where it is now to IND-ready. Pricing available to qualified prospects under NDA.

Cell line & process development

Optimization and scale-up using single-use automated equipment.

Stable-clone development for biologics and gene therapy
Single-use bioreactor process scale-up
Per-gram cost reductions designed in from day one
Process characterization aligned to filing strategy

Gene & viral vector manufacturing

BSL-2-ready GMP production — a rare U.S. capability.

GMP production of gene-based drug products
Complex AAV programs at preclinical and clinical scale
BSL-2 capacity purpose-built for viral vectors
Integrated upstream and downstream workflows

Analytical method development & QC

Methods that travel from early phase to commercial launch.

Method development and validation
Release testing and stability programs
Comparability across material lots and sites
GxP bioanalytical testing with full QA/QC

Regulatory & FDA support

FIH-enabling studies and FDA filings, accelerated by e-documentation.

FIH-enabling preclinical and IND-enabling work
Electronic CTD-ready submission packages
FDA and EU regulatory expertise
Pre-IND interaction preparation and authoring

Integrated clinical execution

Hand off into clinical without changing partners.

Access to 1,000+ global trial sites via partner network
Clinical study strategy and protocol design
Integrated eClinical and CMC data platforms
Real-time, board-ready progress reporting

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