BLA readiness in 14 months
Boost your product with accelerated approval pathways
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 .
PC completion in 4 months
100+ client audits globally
E-mail response within one business day
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
Upstream Process Characterization
Downstream Process Characterization
GenScript 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.
PPQ Relevant Validations