The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy causing many global organizations to investigate the consequences of the tariffs on their overall product portfolio. Companies need to know the facts and have data to support their decisions.
There are several signals that indicate it is time to execute a technology transfer including;
ProPharma's experts have performed hundreds of technology transfers both nationally and internationally. Our team understands the regulations, supply chain channels and the process required to ensure each technology transfer is completed effectively in terms of safety, compliance, costs and timeline. ProPharma has the qualified resources to complete complex physical site transfers in the shortest time possible and have the policies and procedures to ensure that they meet all requirements. Let us show you a plan.
A "technology" may comprise an analytical method or a process to make a product. It could even literally involve physically moving equipment and or people. The "transfer" often means from within your company to outsourcing, from one CMO to the next or from one clinical phase to the next, or to a commercial phase. The reasons for technology transfer are numerous but usually involve capacity and cost. Technology comprises of a sending site and receiving site.
In this blog, we will focus on the transfer of a process from one site to another.
A technology transfer requires always critically looking inwards before you move to the new world. Every technology transfer starts with an inventory of available information about a certain process at the sending site.
The first question is what has been communicated to the authorities. How is the process described in the (investigational) dossier? This usually comprises of the manufacturing part in Module 3 but also involves validation and maybe even answers to questions raised during assessment. Apply this information to your new receiving site. However, is this information still applicable? If not, you got your first set of variations.
Second, it is important to dig a layer deeper. What written information is available at the sending site? This usually comprises of (master) batch records, validation reports, trend reports, deviations, change controls, development data and design space (QbD). Does this all match with the information that is communicated to the authorities? The answer should be yes, but the devil is in the details here. Are you still in compliance after this second assessment?
Once you have categorized this information, it is important to look for non-written information. This means eyes on the shop floor and listening to the operators. You will be surprised at the new information you will learn about "tricks" of operators to make things work better, efficiently or just accommodate a coffee-break. Keep an open and non-judgmental look on the operator performance with respect to the manufacturing process at your sending site. Our advice: A fresh set of eyes helps to objectively assess the information. People working for one product for a long time develop great expertise (and pride) in products, but also blind spots to their process. This is true at all levels in the company.
This allows you to make a proper assessment if your new site can accommodate your product. This can be best done with a live brainstorming session of all relevant subject matter experts (SME). Start with the assumption that everything should be the same and start listing (possible) differences between sending and receiving site. Do not be shy in also mentioning differences in personnel and culture, climate conditions of the receiving site (when abroad), throughput times from warehouse to production and, in general, things that are not directly defined in documents.
The difficulty, if you are working with a commercial CMO, is that investments and final drug product negotiations coincide with these assessments. Furthermore, once you have identified technical differences, it is important to discuss with your regulatory department what kind of implications this has for the timelines of variations per country/region. Goals and intent of a purchasing department (investments and final price), regulatory department (throughput time of variations) and a contract manufacturing site can often lead to interesting discussions.
In accordance with the guidance related to Technology Transfer our approach would be:
The gap-analysis brainstorming session with the SME should result in a living gap analysis document that will guide you through the development part of your transfer. Keep both the sending and receiving site up to date on your planned activities on both sites.
Depending on the cost of the material, status of the design space of the product and experience of the receiving site it is wise to think about a focus-session where the receiving site gets a sense of the (new) material, (new) process and (new) equipment. This generates enthusiasm, preliminary data and commitment at your receiving site and can boost new insights into your gap analysis. Subsequently you should write a protocol for trial batch(es) addressing the points in your gap analysis. Coordinate this phase tightly with your QA and regulatory department. Make clear in your gap analysis what is essential for filling the variation and what is nice to have for other departments. Discuss the need for (re)-validation depending on the design of the process or otherwise you end up with a lot of extra work.