Process Engineering

Kymanox process engineers are able to determine facilities requirements for clinical trials production based on predicted clinical trial size and commercial production based on manufacturing requirements.  We can estimate the cost and timeline for each facility option.  Outsourcing is a growing trend in manufacturing and as a result we’ve helped multiple companies decide between moving to a contract development and manufacturing organization (CDMO) and building their own manufacturing facility.  If you decide to move to a CDMO, we are skilled at the tech transfer required to easily transition.   

Each situation is unique and Kymanox process engineers approach each situation with that in mind.  When scaling from lab-scale to commercial production you need a robust technology transfer process. Tech transfer documentation typically includes process descriptions, process scale-up calculations,  a facility process layout, process flow diagrams, and an equipment list. Documentation is just one part of the tech transfer process, however, and Kymanox takes a thorough approach to tech transfer to make sure everything occurs as expected. Click here to learn more about Tech Transfer at Kymanox.

Investing in the equipment should never have to be a risk. Testing equipment and reviewing documentation for traceability purposes does a great deal towards lowering the risk of your investment. Accepting the equipment only after completing a Factory Acceptance Test (FAT) is industry standard, but the process can be overwhelming. A few ways to make a FAT run smoothly include: 

• Commissioning: Going through testing requirements will help you catch issues earlier. 
• Standardized checklist: Having a standard checklist of expected tests and documentation can ensure you do not forget critical functions. 

• Communication with the vendor: Use your checklist as a guideline for what you expect from your vendor. Be sure they have the required documents available prior to the FAT, and allow them a chance to commission the machine before your arrival. 
• Time: Every FAT comes with unexpected delays. Scheduling more time than you think you need to complete the FAT will pay off. A thorough FAT lowers the risk of an investment. 

Having appropriate FAT experience will help the process run smoothly and easily. At Kymanox, we have used our experience with FATs and Site Acceptance Tests (SATs) to develop standardized checklists for various equipment and often guide clients through the process.