We offer a scalable process in order to help you prepare the clinical supply needed for commercial approval
Drug substance process validation services
For customers preparing for commercial approval and post-commercial approval, Process Validation is a critical and significant set of activities. AGC Biologics has a well-defined approach with supporting Quality Systems to provide you with a targeted path through late-phase Process Validation. Our systems are based on the FDA’s Approved Guidance for Industry and ICH guidelines, using a risk-based lifecycle approach, and consist of three basic stages with supporting validation activities.
Got a project? Let's talk.
- Identification of critical quality attributes and critical process parameters
- Risk assessments
- Process control strategy design
- Bench-scale model qualification
- Bench-scale process characterization/DOE studies
Process Performance Qualification (PPQ)
- At-scale PPQ campaign
Continuous Process Validation Program
Assess reliability, confidence, inter & intra batch variation uncertainties in PPQ sample size selection
This article details two statistical methodologies for calculating the necessary number of process performance qualification (PPQ) runs: the tolerance interval (TI) method and the process capability (PpK) method.
Download the whitepaper to read more.Download
Fill out the form to access "Assess reliability, confidence, inter & intra batch variation uncertainties in PPQ sample size selection"
Supporting Validation Activities
- Mixing and hold time validation
- Extractables & leachables
- Impurity clearance
- API freeze / thaw studies
- Resin/membrane lifetime validation
- Virus clearance validation
- Raw material qualification
- Analytical method validation
- Cell line qualification
- Facility/utility/equipment qualification
- API shipping validation
Quality by Design
The Highest-Standard Approach to Process Validation for Early and Late-Stage Projects
The Challenge —Develop and validate manufacturing processes for two novel molecules, one in phase 1 development and the other in phase 3.