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Process Optimization, Characterization & Validation

BLA readiness in 14 months

Boost your product with accelerated approval pathways

Process optimization aims to increase process robustness and reduce production costs. The key focus areas includes: substitution of high-cost material, upstream titer enhancement, protein quality modulation, improvement of downstream recovery, quality optimization, and process robustness studies.

Process characterization (PC) refers to establishing a strategy of process control by purposely varying operational parameters to determine their effect on product quality attributes and process performance. PC normally starts in late Phase II or early Phase III.

The purposes of PC includes identification of critical process parameters (CPP) that impact critical quality attribute (CQA), determination of manufacturing operating ranges and acceptance criteria, and determination of interactions between process parameters and critical quality attributes.

Process validation (PV) refers to evaluating the process design to determine if it is capable of reproducible commercial manufacture, including design of the facility and qualification of the equipment and utilities & process performance qualification (PPQ).

The purposes of PV includes validation of process, identification of critical process parameters based on risk assessment, and Implementation of the proven control strategy .

Service Highlights

Multidimensional Process Optimization

Enriched optimization experience with regulatory support for process changes
Fast Process Characterization

PC completion in 4 months
Global Quality System

100+ client audits globally
Prompt Reply

E-mail response within one business day
Favorable Unit Cost

2,000 L GMP manufacturing price <$100/g*

*DS unit price (a. Fed batch process in 2000L SUB, b. 7g/L, 70% yield, c. annual batch number≥ 20 batches), including FFS and material cost

Work Contents of Process Optimization

Strategy	Time*	Cost Reduction
Substitution of high-cost material	2 months	10 – 20%
High density inoculation	6 months	Up to 40%
Process parameters optimization	6 months	Up to 40%
Clone change	8 – 12 months	Up to 60%

*When employing multiple process optimization strategies, several tasks are carried out in parallel, and the entire process optimization cycle is determined by the duration of the most time-consuming strategy.

Work Contents of Fast Process Characterization

CPP/CQA Evaluation
- Data collection & risk assessment
Upstream Process Characterization
- Scale-down model establishment and validation
- Design of experiments
- Worst-case condition confirmation
Downstream Process Characterization
- Scale-down model establishment and validation
- Design of experiments
- Worst-case condition confirmation

ProBio offers 2 process characterization (PC) services: fast PC and standard PC, to meet the needs of various projects. Fast PC is appropriate for products with accelerated approval pathways or monoclonal/symmetrical bispecific antibodies in liquid formulation. Standard PC is appropriate for all products, particularly complex molecules such as proteins and asymmetric bispecific antibodies.