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.
Design of Manufacturing Facilities
We conduct feasibility studies and support architectural/engineering and construction management companies in developing conceptual and design packages. We can also work as the client rep directing these companies.Start Getting More Done!
Process Technology Transfers
Our experience includes tech transfer strategy and execution, including documentation, from process development to scale-up to manufacturing. This includes transfer of processes to different locations.Start Getting More Done!
Process Equipment Design
Process equipment sizing, data sheets, piping & instrumentation diagrams, purchase specifications, vendor selection, bid analysis, engineering support during fabrication of equipment, acceptance tests, and validation.Start Getting More Done!
We have extensive experience with manufacturing campaign support, problem root cause analysis, and issue resolution. We help write deviations, CAPAs, investigations, campaign summary reports, and annual reports.Start Getting More Done!
Meet our Process Engineering Experts
Markets That Benefit from Our Process Engineering Solutions
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
We understand why “the product is the process” and how to implement solutions to your unique challenges.
Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.
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
Nathan Blazei Joins Kymanox as Head of Quality
Kymanox, a full-service life sciences solutions provider supporting commercialization of vital medicines and treatments, is proud to announce the addition of Nathan Blazei as Head of Quality. This new role will allow Kymanox to further enhance quality,...
On Demand Webinar: Lessons from Inspiring Women Science Leaders for International Women’s Day
"As women, our ability to pivot and persevere when our lives become disrupted has become a leadership advantage!" ~Jennifer Johns https://kymanox.canto.com/direct/video/lfjpc5oos96hjeis95ger0ib6u/COge77h8J0ePzIoIvDXSggh3J_w/original?conte...
How the FDA Defines Combination Products
Is your product a combination product? Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products. The FDA identifie...