Manufacturing Support
Production hell can happen in the pharma business too. We will be your Mr. Wolf who will solve the problems of your drug product manufacturing process. We’ve been through it many times and are here to help. We know which closets might be hiding skeletons.
For us, it is always important to see the big picture. Our experience with drug product development, the complex knowledge of pharmaceutical processes, techniques, and our deep grasp of organic chemistry combine with our logical and analytical approach. And of course, our zeal for project management.
Our way is to get straight to the heart of the problem, design experiments, evaluate their results, and get out again. We move fast, we think fast, and we are effective. Because time is a factor.
For us, it is always important to see the big picture. Our experience with drug product development, the complex knowledge of pharmaceutical processes, techniques, and our deep grasp of organic chemistry combine with our logical and analytical approach. And of course, our zeal for project management.
Our way is to get straight to the heart of the problem, design experiments, evaluate their results, and get out again. We move fast, we think fast, and we are effective. Because time is a factor.
Allero Therapeutics
During the COVID-19 restrictions, we were looking for a trustworthy company that would assist us in the evaluation of a potential Czech CDMO at various levels, a.o. CMC, and management. We were recommended Kapaji, a group of experienced, industry experts. As the project was very time-sensitive, we were glad that Kapaji was able to perform the evaluation swiftly and with utmost care for detail, giving us important and valuable insight into the suitability of the selected partner. It was a pleasure to work with the knowledgeable Kapaji team, who needed minimal guidance to do an excellent job.
Kees Leenhouts — CTO & COO
We perform
- Troubleshooting and the investigation of routine pharmaceutical production and analytical methods
- Complex approach: from paperwork to shop floor investigation
- Standard and non-standard analytical techniques for API, drug product intermediates, and final drug products
- Investigation of API and drug product stability issues, selection of packaging materials
- Technical support of OOE, OOS, and product recalls
- Evaluation of APIs from new suppliers before implementation (identification of CQAs, such as particle size distribution, wettability, etc., and their experimental verification)
- Support of computer and automated systems under GMP (validation, data integrity, QSR, IT infrastructure qualification, validation, and qualification in the XaaS environment, vendor assessment with a focus on CSV and IT infrastructure, trainings)