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New fill/finish partnership with BioConnection provides end-to-end drug product development under 1 contract!   Read the press release

Process Validation

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.

Stage 1

Process Design

  • 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



Stage 2

Process Performance Qualification (PPQ)

  • At-scale PPQ campaign

Stage 3

Continuous Process Validation Program


PPQ Assessment download graphic2


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.


Stage 4

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



Interested in learning more?

Contact our team

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.