For the drug product manufacturing process need to be robust for commercialization, it is crucial to evaluate and study the criticality of all process parameters. A formulation robustness study evaluates the qualitative and quantitative impact of formulation compositions on the drug product's critical quality attributes. This determines the critical formulation parameters and establishes their operating and acceptance ranges during drug product manufacturing.

Various models for each unit operation were utilized to evaluate the potential impact of process parameter on product critical quality attributes and process performance. Critical process parameters were identified through risk assessments, and operational ranges were determined using OFAT method, worst case studies, and statistical analysis. A systematic quality DP process control strategy was established according to QbD guidelines, based on documented evidence.

● Rapid process characterization completed in about 10 months.

● Experienced team specialized in DP process development and manufacturing according to QbD guidelines.

● Comprehensive program capability from IND to BLA stages.

● Development of QTPP (Quality Target Product Profile), Risk Assessment reports and PC (Process Characterization) Master Plan

● Unit Operation Studies, including Freezer Capability, Freeze-thaw Study, Pump Shearing Study, Mixing Study, Filter Vmax study, Filter Adsorption Study, Hold Up Volume Study, Filling Pump Parameter Study, Filling Bag Flushing Volume, Interruption and VHP Study.

● General Process Studies, including Light Exposure Study, Temperature Excursion study, Process Component Compatibility Study, and Worst-case Study

● Preparation of PC Master Report, Gap Analysis and Tech Transfer.