Hillerød, Denmark
PolyPeptide Laboratories has a European GMP manufacturing site located in Hillerød, Denmark. This 50,000 square foot facility is designed for solid-phase pre-GMP process development and large-scale solid-phase GMP manufacture. The site also supports solution-phase process development.
The Hillerød facility consists of 1 multi-purpose synthesis area (solid and solution phase), 3 purification suites, and one classified isolation suite with lyophilization capacity up 200 kg (ice capacity). With solid-phase reactors of up to 280 L in size, and HPLC columns with internal diameters of up to 60 cm, Hillerød is equipped to produce batches in quantities of grams to multi-kilograms.
Hillerød has successfully undergone 5 inspections by the Danish national regulatory authorities. Expansions and improvements are continual. Additional manufacturing space is currently under development.
