A biopharmaceutical company requested from Synergy to work with their engineering department and help in the optimization and revalidation of their manufacturing process of a therapeutic protein drug product. To integrate the upstream process with the downstream one, we did a re-validation of the downstream process of a monoclonal antibody and performed chromatographic HPLC analysis for samples from different phases such as biomass product separation, product purification, concentration, crystallization, drying and fill-finish among other activities. Along with this effort, there were concurrent effort for optimizing and re-validating the chromatographic testing methods for identification and quantitation of the therapeutic protein molecule in biological samples. After revalidating these methods, they proved to be specific, accurate, and precise and were used throughout the entire processing program. In addition, we got involved in the development and validation of a therapeutic protein lyophilization (freeze-dry) study for another product, by establishing and optimizing the lyophilization parameters (shelf temperature, chamber pressure, drying times, and end point). This study served as a precursor of process development and validation for the commercial processing.
Concurrent with this effort, Synergy’s team was involved in the optimization of the Quality Management System (QMS), providing GMP training, compiling the Biologic License Application which included sections for Establishment Description, Safety/Purity/Potency, Chemistry (CMC), Summary Report, and preparing the facility for FDA Pre-Approval Inspection. Along the line with these activities, our team of consultants were involved in the assessment and remediation of a manufacturing processes and its related quality system, as per 21 CFR 211 and 21 CFR 610 regulations, of a biopharmaceutical company manufacturing drug product. We were also able to provide practical solutions to mitigate and optimize the following processes: Producess and Production Controls for aseptic manufacturing, which included Packaging and Labeling Controls, Master production record, Validation protocols/reports, manufacturing equipment qualifications (IQ/OQ/PQ), and manufacturing process validation. The team’s efforts helped in the reduction of manufacturing related deviations, OOS, and CAPAs, which led to the improvement of the process outcome from about the 3 Sigma level to the needed 6 Sigma level. Also, we were able to reduce the time required for the required biannual verification of the manufacturing process validation from over 4700 hours to less than 2500 hours. The company passed the FDA inspection with no audit findings and shipped the first shipment valued at over $68M.
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