Technology transfer has various connotations in academia, law and business. In the pharmaceutical industry, the concept applies to the transfer of process technology from the R&D stage to a Contract Manufacturing Organization (CMO) for either clinical or full scale production of the Active Pharmaceutical Ingredient (API) or New Chemical Entity (NCE).
You might think it would be an easy handover. The R&D has been done, analytical methods developed and off goes the process to the manufacturing suite. But as it turns out, the process of technology transfer from the lab to manufacturing is far more arduous.
This article will discuss technology transfer problems encountered by CMOs – and what you can do to minimize them.
To make matters more complicated, technology transfers differ in several ways. During Phase 1 or Phase 2 of drug development, for example, the transfer may be undertaken to determine whether the product can be successfully manufactured from a laboratory-scale process to pilot a development scale process.
Such an early-stage transfer requires extensive interaction between scientists. By comparison, a transfer in Phase 3 for full-scale cGMP production and commercialization, which has far more stringent requirements for compliance and process validation, may involve less technical interaction but more regulatory and analytical interaction.
In either case a comprehensive Process Transfer Protocol (PTP) can make all the difference between an efficient transfer and a process that gets bogged down with rework, inadequate protocols, and repeated calls for more information.
Here are the main technology transfer issues from a CMO perspective.
People not familiar with the CMO side of things don’t think about some of these things but they are critical to moving forward efficiently.
If your budget is important to you (and it always is), keep in mind that the more efficiently your CMO operates, the easier it is to control the budget. Do all that you can to help your CMO operate as efficiently as possible. Here’s how.
The key to successful technology transfer is to be as specific as possible by including all the technical information, processes, analytics, reference standards and samples available. The CMO can then compare to what was done previously and won’t have to reinvent the wheel.
Another important factor to keep in mind: don’t hide anything from your CMO. The CMO also needs to know what was tried and didn’t work so efforts won’t be duplicated.
Providing these pieces of critical information to the CMO will help keep costs down. After all, manufacturing facility costs at $75,000 per week are 10 times higher than lab costs (at $7,500 per week), so solid information will save considerable time and money.
The quality of the information provided in the technical package is very important. Here are questions to ask and prior to the handover:
Note that the quality of the information required will change depending on where the drug is in the development process. What is considered high quality information from a pre-clinical study may not be considered high quality information for a product nearing commercialization.
When the drug development process gets closer to the new drug application (NDA), methods and procedures should be validated, whereas earlier stage activities may not require validation.
Regardless of which party writes the final Process Transfer Protocol or whether both parties create it together, it should include the following components:
As the CMO conducts experiments and manufactures test batches, the process description will be revised to characterize the process in light of new knowledge.
The technology transfer package should include:
Any information that is inadvertently left out of the initial documentation in the checklist above may be obtained by interaction of appropriate personnel and by adding appropriate information to the transfer documentation.
Further, throughout the transfer process, both sides should not only communicate fully and often, but also meet face to face. The personnel from the receiving site should become process experts by visiting the donor site and, conversely, donor personnel should be present for initial runs at the recipient site.
The real test of the technology transfer is how well both teams interact when technical issues arise during the execution of the project. Immediate communication by the contract manufacture when technical issues occur is a must. Relationships built during regular communication allow for quick development of action plans to resolve any technical issues as they arise.
Projects move more swiftly and smoothly when the contract manufacturer is viewed as, and performs as, an extension of the pharmaceutical company.
To sum up, the process of technology transfer is an arduous one that takes teamwork, communication, and, most importantly, the ability to foresee potential obstacles that could arise.
Finally, keep this overarching principle in mind: do your best to set up the project and CMO for success.
The technology transfer stage is a critical one to get correct. Aside from the science itself and manufacturing capabilities and scientific expertise, tech transfer, like documentation in the API manufacturing process, is an important-but-often-overlooked component to the success of any project. If you have questions, please call us at (978) 462-5555.
Do you have questions? Talk to Ed.