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PROCESS CHARACTERIZATION

Process CharacterizationProcess Characterization

Process characterization is a critical and highly challenging part of drug development. Zencore has a very mature process characterization platform, and its professional team can deliver high-quality research services for both Zencore-developed processes and client-defined processes.

QbD principles applied throughout ICH Q8–11Multivariate analysis + DoERisk assessment RAScale-down model SDMDesign space DS
Back to Biologics CDMO Services
8major modules
Full-chain services from process description (PD) to design space (DS)
4
process characterization projects completed
3
process characterization projects currently underway
100+
Benchtop bioreactors (2 L / 5 L / 10 L / 20 L)
What We Offer

Zencore's process characterization platform will provide you withService Scope

01Defining the process description PD (process description)
02Define critical quality attributes CQA (critical quality attribute)
03Risk assessment RA (risk assessment)
04Developing scale-down models SDM (scale-down model)
05Multi-factor design of experiments on process parameters DoE research
06Identify critical process parameters CPP (critical process parameter)
07Identify key process parameters KPP (key process parameter)
08Establishing the design space for process parameters DS (design space)
Workflow

Development workflowFive-Stage Characterization

A five-stage research pathway from process definition to design space establishment.

Process characterization workflow: process definition - risk assessment - design of experiments and execution - statistical analysis and prediction - design space
Scale-down model — multivariate analysis (MVA) — design of experiments and analysis — design space, a complete research chain
Process definition
  • Determining the manufacturing process
  • Establishing a batch production database
  • Accumulated prior knowledge
  • Analytical method transfer
Risk assessment
  • Define CQAs & KPAs
  • Risk assessment scoring and ranking
  • Identifying process parameters
  • Formulating research strategies
Design of experiments and execution
  • Developing scale-down models
  • Multivariate analysis
  • Design of experiments (DoE)
  • Seed train and media correlation experiments
Statistical analysis and prediction
  • Linear/non-linear multivariate modeling
  • Identify CPPs & KPPs
  • Worst-case prediction
  • Knowledge management
Design space
  • Worst-case confirmation
  • Model robustness assessment
  • Establishing the design space
  • supporting the scientific soundness of control strategies
Service Advantages

Service advantagesWhy Zencore PC

CoverageZencore's process characterization services cover risk assessment (RA), scale-down model development (SDM), design of experiments (DoE) and execution, critical process parameter (CPP) identification, and design space (DS) establishment, among other modules. The reasonableness of process parameter operating ranges and the scientific soundness of control strategies can be evaluated comprehensively and in depth.
PlatformWhether the process is developed in-house by Zencore Biologics or is the client's established process, Zencore's professional team can provide clients with high-quality research services, supporting the scientific justification of operating ranges and control strategies in regulatory filings.
01

Advanced concepts

Applies internationally accepted QbD principles throughout process characterization, process validation and continued lifecycle management (ICH Q8–11).

02

Rigorous

Uses multivariate analysis methods and DoE experimental design methodology, applying statistics to scale-down model development and to analysis of the relationships between process parameters and critical quality attributes.

03

Highly flexible

For the client's established manufacturing process or processes developed in-house by Zencore Biologics, process characterization studies can be conducted.

04

Experienced

To date, Zencore has completed 4 process characterization projects, with 3 projects currently underway.

Case Study

Case studiesSuccess Story

CASE

Process characterization study for a Class 1 novel antibody drug

Obtained NMPA marketing approval in 2018NDA registration studies recognized by NMPAFirst domestic new drug and manufacturing approval for this target
Project background

A client's Class 1 novel antibody drug, at the marketing registration (NDA) stage, required upstream and downstream process characterization to support the filing.

Zencore's actions

Zencore successfully completed Phase III upstream process characterization projects, designed Phase III downstream process characterization protocols, and assisted the client in completing purification process characterization.

Final results

This study received NMPA recognition during the NDA process, and the product obtained marketing approval in 2018. The research helped the client stand out among competitors and greatly accelerated the approval timeline — the first domestic manufacturing approval for a new drug based on this target.

Process characterization outputs: risk priority scoring, PCA and DoE response surface panels
Research evidence recognized by NMPA: risk priority scoring · PCA · DoE response surface and design space
Key Instruments

Main equipmentKey Equipment

A fleet of equipment for large-scale scale-down model parallel reactions and chromatographic characterization.

Benchtop bioreactor array

100+ benchtop bioreactors

Covering 2 L, 5 L, 10 L and 20 L scales, supporting upstream scale-down model development and parallel DoE experiments

AKTA chromatography system matrix

11 ÄKTA chromatography systems

together with multiple supporting analytical instruments, underpinning downstream scale-down models and process parameter characterization studies

Scientific justification of operating ranges and control strategies

From risk assessment to design space establishment, Zencore's process characterization platform provides solid statistical and process-understanding support for your regulatory filings.

Inquire about process characterization studies