Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and regulatory limitations. Why are technology transfers so difficult? What are the key factors for a timely and successful transfer? What is the right timing?
This blog covers the questions we have heard most frequently across more than 400 completed tech transfers. We’re sharing our collective experience and expertise to ensure your success in managing product and process transfers.
Why are technology transfers so difficult?
- Effectively communicating thousands of details connected to the 75 key work packages across all areas of an organization for a process that is constantly changing requires extensive oversight and alignment. Any deviation can have consequences for the quality, efficacy, and safety of your product, and can result in regulatory submission delays.
What key information / process control measures need to be established early?
- Quality systems including data integrity, identification of critical quality attributes, and critical process parameters are important to collect early in the process in documented form and will pay huge dividends throughout the product lifecycle.
How long does a technology transfer take?
There are several steps that typically help predict a transfer timeline:
- Site selection, when necessary, can take a few months up to a year. The timeframe is often dictated by the responsiveness of the receiving site and negotiations around related contracts.
- The technology transfer execution can take between 6 months to 2 years depending on equipment sourcing, the stability data that is required, and the efficiency of planning and issue resolution throughout the project.
- Finally, regulatory requirements must also be successfully met.
What is the right timing for a preclinical stage company to start preparing for regulatory considerations?
- Typically, about a year before you are ready to enter the clinical phase, depending on the quality of the data you have generated so far. If you’re developing a complex biologic or gene/cell therapy, often companies need additional early-stage feedback two years or more before entering the clinic.
When transferring a product that is transitioning from Phase I to Phase II, what are the qualification requirements?
- As you transition to Phase II, you need to look ahead and begin aligning to processes and requirements expected further down the lifecycle. When producing for Phase III, the process needs to be the same as for after launch. This means that the processes and methods need to have a control and validation strategy. Adequate documentation and justification should be built in up front, and generating material for Phase II needs to support with this strategy as well.
What are the unique considerations when transferring to single-use technology?
- We have seen a shift away from single-use technology primarily because of the desire to go to continuous manufacturing, but also due to issues with single-use technology such as material shelf life, replacement time, inventory costs, disposal costs, environmental concerns, leaks, contamination, and employee exposure. The COVID-19 pandemic has exacerbated this effect with big shortages of disposables (flow kits, bags, filters, etc.) due to increased production of vaccines. These risks versus the high startup cost of multiple-use technology (e.g. cleaning strategy) need to be considered in advance.
What are some of the most important considerations when looking at a site to transfer to?
- We recommend looking at quality, compliance, capacity, customer service, and cost. Cost is the last consideration because the status of the other considerations will have a higher impact on overall cost than the cost per unit.
- Site selection is a balancing act of each of these parameters to find the best match for both your short-term and long-term goals.
- The key factor for a successful long-term partnership often resides in the customer service category, so remember to evaluate attributes such as communication and dependability.
How do you handle a transfer situation where there is little to no data from the sending site?
- Often, there is more information available than is apparent at first. Many key documents are included in the regulatory submission, furthermore annual reports should be accessible for a sponsor, but leadership needs to be aligned on transfers and provide required support. “Man in the plant”, financial support, and other drivers may be needed to align long-term goals with short-term issues.
How do you handle a transfer when the sending and receiving site are not cooperative with each other or are having difficulty understanding one another?
- Change the paradigm. Identify the true leaders in an organization, understand the drivers and change the situation to align the needs of all parties involved. Meet often and make sure there are clear expectations (outcomes) using deliverables, timelines, etc.
- In some cases, another option is to partially redevelop and validate the manufacturing process and analytical methods at the receiving site, complemented with additional CMC testing to ascertain comparability of the products.
What are the most important raw material considerations for phase appropriate development and manufacturing?
- Like with site selection, we recommend looking at quality, compliance, capacity, customer service, and cost.
- It is important to realize that a large portion of issues during commercial manufacturing stem from the materials that are used. Therefore, in this stage thorough understanding of the material, its impurities, and/or potential for reactivity is critical for maintain a secure, steady supply.
What are the key success factors for a timely and successful technology transfer?
- Communication between sending and receiving site
- Availability of information for both the receiving site and sending site
- Availability of materials at the receiving site
- Executive leadership buy-in with documented, signed project charter
- Capability of the receiving site
What experience does ProPharma Group have in executing successful technical transfers?
- Number of product technology transfers managed: 423
- Combined number of years of technology transfer experience: 96
- Types of products transferred: Small Molecule, Large Molecule, OTC, ATMP, and Medical Device
- Transfer Stages Managed: Clinical to Production, Post-production
- Technology Transfer Resources We Utilize: 9 Gate Transfer Approach, 6 Gate Transfer Approach, Agile Methodology, PMI expertise, ISPE best practices
If you have a question we didn’t answer here, connect with our team and learn more about our solutions for successful and efficient tech transfers.
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