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4. BIOTECH SUMMIT AUSTRIA 2026

13 – 14 Oct 2026 | Innsbruck, Austria

ServiceUpdated on 12 October 2026

Integrated CMC development for DS and DP with accelerated timelines

Business Development Director, Europe at WuXi AppTec

Gräfelfing, Germany

About

  • CMC competency: 1.000+ CMC submission packages written to support global IND and NDA filings during 2019-2026

  • Speed: With our integrated CRDMO model we can deliver entire IND enabling package, including DMPK/Tox and CMC dossier typically within 7-8 months, for complex small molecules and TIDES within approx. 10 months.

  • EU batch release: With our own QP based in our European Headquarter in Munich-Gräfelfing we can manage EU Batch release for clinical and commercial supply.

  • Reliable development timelines in late stage: 180+ NCE PPQ (Process Performance Qualification) completed 2018-2025 with 100% success rate & rich track record supporting first time US FDA and EMA approvals

  • Global manufacturing network:

    • US: We will become operative with our new drug product site in Middletown, Delaware (US) for OSD in q4 this year and for injectables in q4/2027.

    • CH: We added PSD-4 (GEA) SSD capabilities in our EMA, US FDA / Health CA and JP GMP approved OSD site in Couvet, Switzerland becoming operative in October this year

    • SG: We will have our GMP manufacturing site operative in January 2027

Organisation

WuXi AppTec

Company

Shanghai, China

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