Rapid Antibody Gene-to-Drug-Substance Development & Manufacturing
Accelerate your path to clinic with a proven, integrated platform.
Catalent’s integrated antibody development platform helps you move from gene construct to GMP drug substance in as little as 8 months*, enabling faster milestones and reducing risk. Our proven process combines advanced technologies, parallel development strategies, and decades of expertise to deliver a robust, scalable solution for your clinical program.
Why Partner with Catalent
- Speed-to-clinic: Gene to GMP drug substance in 8 months*
- Risk Mitigation: Proven platform processes, regulatory expertise, and well-characterized conditions
- Scalability: Scalable solutions from pilot non-GMP runs to full GMP production
- Manufacturing assurance in the U.S.: Reliable U.S. supply supported by proven quality systems
Integrated Development and Manufacturing Pathway
| Cell Pool Production | Ambr250 Top Clone | Pilot Large Scale Non-GMP Production |
CGMP Large Scale Production |
|---|---|---|---|
| 10L | 2 × 250 mL | 250 L (100 L) | 1000 L (500 L) |
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Best Fit for This Platform
This accelerated solution is optimized for proteins with the following attributes:
- IgG1 or IgG4 mAb with pI greater than 7.4
- Low propensity for aggregation, less than 5% in culture and post-capture
- Stability at low pH for more than 60 minutes
- Final BDS concentration of 50 mg/mL (frozen)
- Liquid drug product stability at 5°C
*The 8-month timeline applies to traditional monoclonal antibodies (mAbs).
Scope of Services
Catalent provides an end-to-end, integrated scope spanning early development through late-stage clinical and commercial readiness, using a platform-based approach designed to scale with your program.
- Robust cell line development using GPEx® Lightning technology
- 10 L bioreactor cell pool production
- Top clone selection with Ambr250
- Downstream process development
- Formulation development
- Master Cell Bank creation and testing
- Analytical method development and qualification
- 250 L pilot non-GMP run (100 L)
- 1000 L CGMP run (500 L)
Program Assumptions
This platform-based approach is supported by the following standard assumptions:
- ≤10 g/L titer processing
- 14-day production duration in terminal vessel
- Application of platform purification and analytical methods
- Procurement of materials within 45 days of program initiation
- Process finalized at small scale using Ambr250
- Larger-scale non-GMP run informs CGMP manufacturing after the first batch
Accelerate What Matters: From Gene to Drug Substance in Just 8 Months