Shilpa Biologicals unveils new bioconjugation facility for ADCs in Karnataka. Offers payloads, mAbs & conjugation under one roof. Operational by 2025.
Key Expansion Highlights
✅ New Facility: Dedicated bioconjugation suite at Dharwad, Karnataka
✅ Operational Timeline: Validation underway, client onboarding from September 2025
✅ Strategic Advantage:
- One of few global CDMOs offering end-to-end ADC manufacturing
- Integrated services: payloads/linkers, mAbs, bioconjugation in a single campus
✅ Regulatory Compliance: USFDA-approved HPAPI facilities
Advanced Capabilities
1. HPAPI & Payload Expertise
- Manufactures 40% of oncological HPAPIs in use globally
- 10 cGMP suites handling ultra-potent compounds (OEL <0.01 µg/m³)
- Multi-ton capacity for high-potency payloads & linkers
2. Bioconjugation Suite Features
- 200L single-use bioreactors for ADC production
- Lyophilization capacity: Up to 65 kg
- Development labs for process optimization & analytics
3. Fill-Finish Support
- Hyderabad facility offers cytotoxic fill-finish in isolator-based lines
Why This Matters?
🔬 ADC Market Growth: Global ADC market projected to reach $30B+ by 2030 (CAGR ~20%)
🌍 Supply Chain Resilience: Reduces reliance on fragmented ADC manufacturing
💊 End-to-End Solutions: Attracts US/EU biotechs seeking single-partner CDMOs
CEO’s Vision
“The ADC clinical pipeline is booming, but few CDMOs can support the entire workflow. Our co-located services—from payloads to bioconjugation—are drawing strong interest from innovators needing a reliable partner from discovery to commercialization.”
– Dr. Sridevi Khambhampaty, CEO, Shilpa Biologicals
Industry Impact
- Positions India as a global hub for complex biologics
- Strengthens “Make in India” in high-value biomanufacturing
- Creates skilled jobs in Karnataka’s biopharma sector