This specialized case study explores Kymanox’s approach to executing commercial technical operations through technology transfers and developing Continued Process Verification (CPV) programs for an on-market Oral Solid Dose (OSD) product. Our team of SMEs collaborated closely with stakeholders to implement measurable improvements across Contract Manufacturing Organization (CMO) qualification, process optimization, and regulatory compliance to ensure market readiness in the U.S.
CHALLENGE
SOLUTION
RESULTS
- Execute two (2) commercial technology transfers for an OSD product available in multiple strengths.
- Ensure full regulatory compliance while optimizing the transfer of manufacturing processes and analytical methods.
- Identify and qualify CMOs to support scalable production.
- Performed rigorous evaluation of multiple CMOs using technical assessments, scorecards, and matrix comparisons, selecting two (2) qualified partners.
- Developed and executed comprehensive technology transfer plans, encompassing Process Performance Qualification (PPQ) pre-requisites, method validations, operator training, and regulatory documentation.
- Conducted Design of Experiments (DoE) to optimize compression process variables and define a robust manufacturing design space.
- Defined acceptance criteria, supported PPQ batch manufacturing, and successfully submitted CBE-30 Filings to FDA for regulatory approval.
- Analyzed historical data and created CPV plans and Standard Operating Procedures (SOPs) to maintain ongoing process control.
- Successfully transferred and validated manufacturing processes at two (2) CMOs, achieving regulatory approval and commercial market readiness in the US.
- Enhanced process efficiency and control to ensure consistent and high-quality OSD product batches through technical operations excellence.