Process Engineering Capabilities
Kymanox has experts in design of manufacturing facilities, process tech transfers, process equipment, and process support across the biotechnology and pharmaceutical industries, including novel therapies. We help you get your product to market and keep it there.
Meet our Process Engineering Experts
Nicole Bridgers
PRINCIPAL PROCESS ENGINEER




Markets That Benefit from Our Process Engineering Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics & Cell and Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.




The Kymanox Difference
At Kymanox we are more than consultants. We are partners with our clients and create custom solutions that meet each client’s unique needs.

"Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.

Proven Broad Expertise
Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.

Flexibility & Agility
At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
Frequently Asked Process Engineering Questions (FAQs)
How will your process engineers help us to develop our process from a lab-scale process to clinical trials and through commercial manufacturing?
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.
What kind of documentation is needed to scale up our lab-scale process to commercial-scale in a manufacturing facility?
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.
What’s involved in a Field Acceptance Test (FAT)?
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.
Read the Latest at Kymanox
The Factor Podcast: Winning Formula to Navigate Combination Products
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. Susan Neadle recently penned the highly anticipated "Combination Products Handbook," a practical guide that collects her years of industry experience into a compr...
The Factor Podcast: Transforming Nursing Through Innovation and The Evolving Role of Nurses in Advancing Patient-Centered Care
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, we speak with industry leader, Dr. Bonnie Clipper, to discuss innovations in technologies to empower nurses and improve patient care. Dr. Bonnie C...
The Factor Podcast: Exploring EUDAMED Requirements for EU MDR
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this informative episode of The Factor, we sit down with industry experts, Dr. Christiana Hofmann and Richard Houlihan, to discuss EU MDR's implementa...