The transfer of pharmaceutical product and process knowledge can be a real challenge. Whether you are bringing your methods and processes to PMI Bio or we are developing them for you, our experience and disciplined approach can ensure a seamless transition and save you time and expense.
Tech transfer activities are methodically performed and documented, and provide the basis for control strategies, process validation, and ongoing process improvements. Our goal, through clear and open communication between sending and receiving sites, is to identify key areas of knowledge as well as areas for improvement.
As we manage your tech transfer, we will apply our prior knowledge of similar projects while successfully resolving all the details.
- Analytical methods and development
- Raw material and product specifications
- Scale-up plan
- Critical process parameters (CPP) and critical quality attributes (CQA)
- Formulation, filling, and packaging specifications
- Batch records and procedures
- Cleaning methods and cleaning validation
- Overall validation strategy
“We have the experience and proven track record to successfully plan, implement, and release your products for clinical operations.”
BS in Biochemistry
- Head of analytical development/formulation, quality assurance, and engineering/facility management
- 20 years’ pharmaceutical, biologics, research, and clinical trial experience including leadership positions within QA, QC/analytical development, and engineering and validation
- Was site head of quality for a facility that manufactured a blockbuster biologic product and led engineering and validation groups for design, construction, qualification, and licensure for two pharmaceutical facilities ($450M & $720M)
- Passions: Travel, baseball, and Ironman triathlons