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Rondaxe TechTransfer

Standardized & Efficient Transfer of Technology

TechTransfer is software that standardizes and facilitates the accumulation and accurate transmission of pharmaceutical process information.

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Why TechTransfer?

The Value of TechTransfer

Transferring process know-how from one organization to another is fraught with potential serious failures. If the transferring organizations commit enough resources in the effort, the number and criticality of errors and miscommunications can be minimized and failure avoided. However, the effort required to achieve the needed mitigation can be more than most organizations are able to expend and the time for the effort is almost always limited.

THE OLD WAY

Manual Transfer

Gathering the information for the transfer of a synthetic route from a pilot plant to a manufacturing plant and presenting it a manner that assures the receiving party understands the information usually requires one or two professionals 4 to 6 weeks.

  • 1 or 2 Dedicated Professionals
  • 4 to 6 Weeks Timeline
  • Susceptible to Human Error
  • Non Standardized Documentation which may require interpretation by other professionals
The New Way

Using TechTransfer Software

Using the Tech Transfer Tool to semi-automatically prepare a recipe for each step which then automatically prepares bills of material, parameter tables, process flow diagrams, reactor fill volumes, and IPC test lists the subject matter experts need spend a week or less. The tool saves 3 to 5 weeks time on average.

  • 1 Professional
  • 1 to 2 Weeks Timeline
  • Automated Documentation
  • Reduced Human Error With Built in Validation
  • Documentation Created in Useful Formats Specific to Process Engineer, Plant Scheduler, Analytical Chemist, QA Manager, and Materials Manager
About TechTransfer

Key Benefits

Increase Speed

Streamline process creation and communication to increase time to market.

Reduce Risk

Reduce remediation and non-compliance which can cost thousands of man hours, lost time, and revenue.

Data Always in Sync

Always have documentation that is current and synchronized w/the latest process.

Streamline Information

Key information is automatically generated in an easy to read format, standardized format.

Standardize Collaboration

Providing efficient communication of information between all functional areas.

Improve Communication

Providing efficient communication of information between all functional areas.

How it Works

Create a Recipe

Create a step by step recipe of your process using standardized action words, defined materials, equipment, and common parameters.

Increase Speed

Automate Documentation

After the recipe is created, your documentation is automatically generated specifically for each professional  including.

Case Study

Global Biotech Awakens from Tech Transfer Nightmare

The Client

A global biotech client needed to transfer a late phase clinical project to a new manufacturer. They were approaching product validation and commercial launch. The product had more than 6 years of development and extensive batch history.  There were several hundred source documents available.

The Problem

Incredibly tight timelines for transfer were required to meet the launch timeline.  Many functional areas were working on different tasks, but the team was not communicating well.  The team was also working from different source documents, introducing a high risk of non-compliance and deviations.

The Solution

Rondaxe employed the TechTransferTool to facilitate the process.  We standardized and coordinated the information betweengroups, providing a rapid, seamless techtransfer with no errors.

The Tech Transfer platform providedefficient and rapid coordination with keyinformation to provide consistencybetween all users. This allowed for better, more focused discussions on the issues thatmattered, saving millions of dollars and countless hours of wasted time.

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