Manufacturing Science & Technology

Product Lifecycle Management Requires Expert Guidance

Kymanox’s Manufacturing Science and Technologies (MS&T) team works closely with our clients to develop, improve, scale-up, transfer, and prepare manufacturing processes for clinical and commercial production. Our team applies Kymanox’s Ideal Knowledge Transfer methodology and risk-based approaches when performing assessments, process engineering, process validation and technical project management. Skilled services in the following:

  • Technology Transfer
  • CDM Search & Selection
  • Process Validation
  • Technical Writing
  • MS&T Capabilities

    MS&T services ensures continuous process improvement, implementation of new technologies and products, scale-up and troubleshooting.

    Technology Transfer

    Risk Assessments, Process Descriptions, Quality by Design (QbD), Manufacturing Control Strategies, Technical Project Management.
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    CDMO Search & Selection

    Global search for CDMOs, development of Requests for Proposal (RFP), communication with vendors, evaluation of vendor capabilities.
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    Process Validation

    Process Validation Master Plans (PVMP), Development / Process Characterization, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
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    Technical Writing

    Development or improvement of policies and procedures for Technology Transfer, Process Validation, Equipment Operation, and Manufacturing & QC Processes.
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    Voice of the Customer

    "The Kymanox team is trustworthy, reliable, and competent."
    "They quickly pivoted to my requests and adapted to my style."
    "Kymanox has assisted TFF Pharmaceuticals on a number of different types of projects."

    Frequently Asked 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 a 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, Quality Management System (QMS), and other systems should always be among your first tasks before starting an 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
    Make sure you start with a detailed gap assessment. Within a few weeks, Kymanox can help you get a great start where you can make well-informed decisions and then we can help you close the gaps with our global network of employees and contractors.
    What is a Detailed Product and Process Description (DPPD) and why do I need it?
    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 needs 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.