Bilthoven Biologicals BV | Bilthoven Biologicals Drug Substance and Drug Product Facilities

EU-based GMP manufacturing DS/DP facilities for biologics

1. Drug Substance: multi-purpose, single-use facility for (viral vector) vaccines and biologics, capability for adherent and suspension , cell culture (2x trains), USP with 3x 2,000L scale SUBs and DSP (2x trains) with single-use technology
2. Drug Product: multi-purpose filling line for syringes and vials

These are new state-of-the-art facilities with much flexibility for viral vector, vaccines and other biologicals, fully supported by QA/QC/QP

As a strategic partner to BBio, the following benefits are available

• Access to fully operational GMP facilities for DS and DP in EU
• Flexibility to manufacture clinical and commercial material in EU
• Support with QA/QC/QP infrastructure of BBio for release of clinical and commercial material
• Lease GMP facilities with GMP trained staff, without substantial CAPEX investment required to establish GMP certified infrastructure
• A long-term strategic collaboration, with GMP manufacturing infrastructure in EU ensured