Technology Transfer Capabilities
Our approach is heavily based on following CGxP documentation best practices and has been honed over a decade of proven past performance.
Proven Tech Transfer Toolkit
Through our extensive experience we’ve built a comprehensive suite of SOPs and templates for navigating the tech transfer process.Start Getting More Done!
Experts With Broad Experience
We offer expertise on all stages of tech transfer including prerequisites, project initiation, information exchange, planning, execution, and verification.Start Getting More Done!
Synchronized Change Process
Kymanox treats tech transfer as a change process that is synchronized with the Quality Management System (QMS) and regulatory submissions.Start Getting More Done!
Right First Time Execution
Kymanox helps you avoid costly and often irreversible missteps. Together with you, Kymanox helps plan and execute Right First Time Technology Transfers.Start Getting More Done!
Kymanox Technology Transfer Resources
Webinar: THE ART OF TECH TRANSFER - Using Gap Analysis to Avoid Regulatory Pitfalls
In this 1-hour webinar you will:
- Learn about the industry-proven approach Kymanox uses to help clients of all sizes successfully complete tech transfer projects on schedule and on budget
- Discover the key role that gap and comparability assessments play in effective tech transfers
- Explore regulatory impact related to tech transfer strategy in biopharma, combination products, and cell & gene therapies
Infographic: Six Stages of Technology Transfer - Considerations and Deliverables for Your Life Science Project
A guide across all stages of tech transfer including prerequisites, project initiation, information exchange, planning, execution, and verification.
Meet our Technology Transfer Experts
Markets That Benefit from Our Technology Transfer Solutions
The Kymanox Technology Transfer Difference
We combine people, process, and systems to produce seamless tech transfers that deliver “Right First Time” solutions
Product, Process, & Relationships Approach
Our approach to a successful tech transfer includes creating a good relationship between receiving and sending sites in addition to ensuring full product and process understanding.
“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.
Frequently Asked Technology Transfer Questions (FAQs)
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.
What is technology transfer?
Every time your organization contemplates moving a product from one location (e.g. lab, manufacturing facility, country) to another, you enter the domain of technology transfer. The technology transfer process is complex with multiple steps performed in a specific order, requiring a significant resource commitment from many different groups at both the transferring, and the receiving organizations, for activities often spanning many months. A successful technology transfer requires comprehensive planning, effective coordination and first-time-right execution, in order to meet, often aggressive, timelines.
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
https://kymanox.canto.com/direct/video/lfjpc5oos96hjeis95ger0ib6u/COge77h8J0ePzIoIvDXSggh3J_w/original?content-type=video%2Fmp4&name=KYM-IWD-Panel-08MAR2021.mp4 "As women, our ability to pivot and persevere when our lives become disrupted has become...
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 identifies.Ta...