Catalent Madison: Clinical & Commercial Drug Substance Development

If you're evaluating CDMO partners for biologics drug substance, the depth of Catalent Madison's manufacturing infrastructure is worth a close look. The site runs five GMP trains spanning 250 L to 4,000 L single-use batch scale, with 8,000 L and 10,000 L capacity coming online soon, making it one of the more scalable options for programs moving from clinical into commercial production.

The cell line development story is specific. GPEx Lightning technology generates high-titer, stable CHO production cell lines delivering 15+ g/L expression, using proprietary dock-directed integration via the CHOZN GS knockout host with more than 100 characterized integration sites. That predictability matters when you're trying to compress timelines. The Rapid Antibody platform puts gene-to-GMP drug substance delivery at roughly 8 months, which is genuinely aggressive for a fully GMP-compliant path.

The track record backs it up: 30+ years in biologics, 600+ antibodies developed, 24 commercially approved products built on GPEx technology, and 160+ active clinical programs. Process development, analytical, QC, and stability testing are all in-house.

Visit biologics.catalent.com to see current capacity availability and technology transfer timelines for your program.