MS&T & Supply Chain Capabilities
At Kymanox, the Manufacturing Science & Technology (MS&T) and Supply Chain team can help bring your product from concept to commercialization and deliver it to your patients in the fastest and safest way.
Full Development Life Cycle Management
With global experience in the biopharmaceutical and medical device industries, we provide support for all product development phases from early clinical to post-commercial life cycle management.Learn More
Concept to Commercialization
We provide the right solutions and expertise for tech transfer and supply chain management when you need to pick a new manufacturing process, analyze and improve your existing one, or expand production.Learn More
Broad Support Capabilities
Experts in PAI & commercial launch readiness, control strategy development and implementation, process optimization and variation reduction, sample plan strategy, and serialization planning and implementation.Learn More
Analysis and Reporting
Extensive analysis and reporting tools including resource and infrastructure gap assessments, pre-ERP and ERP supply chain evaluations, cost of goods sold (COGS) analysis, and CGxP statistical analyses.Learn More
Meet Our MS&T & Supply Chain Experts
Markets That Benefit from Our MS&T & Supply Chain Solutions
The Kymanox MS&T & Supply Chain Difference
The Kymanox MS&T and Supply Chain Team offers unmatched expertise and a full suite of solutions for all your product development phases from early clinical to post-commercial life cycle management.
Complete Suite of Services
The Kymanox MS&T and Supply Chain Team provides you complete solutions that leverage the full knowledge base of our experts across other related functions (e.g., Quality, Regulatory).
Solutions from Lean to Large
Whether you want to have a lean operation or you need to have sufficient safety stock, our team will analyze alternative scenarios for you and help you implement the option that works best for your company!
“Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
Frequently Asked MS&T & Supply Chain Questions (FAQs)
When it comes to procurement of consumable, raw materials, how does Kymanox address the current shortage problem?
Supply chain has become the #1 issue during COVID, as many companies cannot receive their materials in time, due to the focus on few critical organizations to support COVID-19 vaccinations. There is no easy solution to this problem, but Kymanox can help you to ensure you evaluate all the options you have and also think out of the box to minimize the risks. We have relationships with both large vendors and small local vendors who may be able to address your needs. We can analyze your situation to see if we can offer further process improvements to level-load the material needs. We will integrate with your team to understand your processes and bottlenecks and analyze how to modify your processes or find alternative materials, as needed, to minimize the impact of your supply chain problems.
What is your technology transfer approach?
At Kymanox, we believe technology transfer is a holistic process that is accomplished with Ideal Knowledge TransferTM (IKT). Our branded technology transfer methodology combines technical project management, sound science and engineering, quality and regulatory expertise, and business acumen to ensure "Right First Time" execution. Learn more about our technology transfer services here.
What kind of gap assessments do you offer and when should I contact Kymanox?
A gap assessment of your processes, QMS, and other systems should always be among your first tasks before starting a major/important project. This is especially important if you are doing one of the following:
- Acquiring a new facility
- Starting a new operation
- Getting a new FDA inspection for your product
- Analyzing manufacturing processes that are underperforming
- Considering a new market/geography for your product
- Benchmarking a long running product
What is a Detailed Product and Process Descriptions (DPPD) and why do I need that?
Although the DPPD is not a mandatory document that is required by the FDA, it is an essential document for a successful tech transfer process. Our subject matter experts (SMEs) will work with you to document all process and product history. Everything is summarized in a detailed report, and this document covers everything from product specifications, process details, in-process checks, and critical equipment, to material and critical equipment vendors, tests done on materials and processes, and raw materials specifications. Many companies prefer to keep their DPPD up to date, as it is also a proven tool that supports training of new employees.
When is the right time to start planning Analytical Method Transfer?
Analytical Method Transfer is one of the most critical, yet usually initially neglected, activities during tech transfers. Many companies underestimate the time method transfers can take. All the associated materials need to be identified, ordering of the materials, and planning of the transfer need to be assessed at the very beginning of the project. At Kymanox, we create and manage a very detailed tech transfer timeline by talking to all stakeholders, ensuring nothing is neglected that can push out the timeline.
Read the Latest at Kymanox
Nathan Blazei Joins Kymanox as Head of Quality
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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 identifies.Ta...