Your Tech Transfer Questions Answered: How To Successfully Onshore A Mid-Phase Project

By Rich Richieri, Chief Operations Officer, Avid Bioservices

While offshoring biologic development and manufacturing was once a strategic play for drug sponsors looking to save money, the tides have turned and now many are onshoring production with domestic CDMOs. The widespread shift to domestic manufacturing was born of several factors, including supply chains vulnerable to geopolitical tensions, regulatory incentives, and tariffs, but for most U.S. sponsors, the choice boils down to mitigating uncertainty. Ideally, the relationship between sponsor and CDMO should be one of stability and reliability, and in the current geopolitical environment, a domestic CDMO affords its customers a better opportunity to secure both.

Opting to onshore operations in the mid-phase of development — Phase 2 or 3 clinical trials — is achievable but complex. The tech transfer from an international to a domestic CDMO can yield unique challenges that delay project timelines. However, with an experienced CDMO adept at navigating mid-phase tech transfer, sponsors will be well prepared to tackle these obstacles and steer their products toward commercial success.

Why Are Sponsors Opting To Onshore?

The U.S. government’s intent to pass the Biosecure Act has been a huge impetus for U.S. pharma companies to pivot to domestic manufacturing. The draft legislation aims to restrict the U.S. government from working with biotechnology companies of concern (BCOC), or companies “under the control of foreign adversaries […] that pose risks to national security based on their research or data collection.”¹ Under the Biosecure Act, federal agencies and recipients of federal funds are prohibited from using a BCOC’s services or equipment or entering into contracts with BCOCs or other companies that use their services. If passed, the act seeks to protect the IP of U.S. companies and mitigate risks to U.S. national security.

In addition to this legislation, the Trump administration has also proposed a 100% tariff on branded or patented drugs that are manufactured outside of the U.S. — unless a company is building a factory in the U.S. — amid an effort to lower drug prices and increase drug manufacturing in the U.S.² Though these tariffs have not yet been enacted, the looming possibility is leading many sponsors to proactively secure manufacturing slots with U.S. CDMOs.

Beyond geopolitical concerns, partnering with an international manufacturer comes with inherent hurdles, including navigating time differences, language barriers, and less convenient audits and/or site visits. Onshoring can alleviate these obstacles and enable more stable supply chains; the key to success is mitigating risks during the tech transfer stage.

What Are The Common Pitfalls When Transferring From International to Domestic CDMOs?

In the transition from international to U.S.-based CDMO, a number of difficulties might arise. First and foremost, the transferred process may not be as robust as purported. In the initial data review, the receiving CDMO might identify indications that the process does not work as advertised, or gaps that make the process unsuitable for commercial-scale manufacturing. For clients looking to maintain speed at the outset, the prospect of changing their existing process may seem daunting. However, adapting a process to be more robust and scalable at the tech transfer stage will save money in the long run.

Another challenge is the comprehensibility of the incoming data. When transferring data from an international CDMO, documentation may be written in another language, rendering data challenging to decipher. Furthermore, a CDMO that wants to retain a client may not readily provide the necessary information for the tech transfer, leading to costly delays. The CDMO might also design processes that are not easily translated to another facility, further complicating this delicate puzzle.

Cell line quality is also important to consider. No matter their origin, cell lines can be finicky and sensitive to certain parameters, i.e., pH or temperature. The receiving CDMO will have the added task of evaluating the quality of the cell line being used to determine whether adjustments need to be made.

How Do I Mitigate These Challenges To Ensure Speed And Efficiency?

To promote a seamless tech transfer, opt to onshore to a domestic CDMO with the knowledge to deftly navigate potential pitfalls. At Avid Bioservices, our team has 30+ years of biologic manufacturing experience, which is bolstered by our familiarity with the considerations needed to move successfully from international to domestic production.

We leverage a rigorous, step-by-step approach to tech transfer that leaves no stone unturned, conducting a side-by-side comparison of the raw materials, equipment, assays, and facilities used in the existing process against our offerings. Some materials and components of the process may integrate seamlessly into our facilities, while others need to be replaced or adapted. For example, if the previous CDMO used different bioreactors, we evaluate how they compare to ours and how this could impact a process. By conducting a thorough analysis upfront, we prevent mistakes or surprises down the road.

For clients looking for efficiency, we recommend using the Avid standard: our platform processes and assays that have already been reviewed and accepted by the FDA in previous client submissions. Using our templated workflows supports efficient onboarding and smooth regulatory interactions. Plus, our team has ample experience working with platform components, helping clients to establish confidence in their processes.

Overall, Avid strives to foster quality from the outset and right-first-time manufacturing via our thorough methodology for protocol generation and design. Across the company, we emphasize a culture of quality and a commitment to cGMP standards. By devoting a significant portion of budgets to quality, we help clients avoid costly mistakes, saving them money in the long run.

What Are The Key Onshoring Lessons Learned?

At Avid, we regularly onboard clients who had previously been working with international CDMOs, including those in Europe and Asia. Over the years, we have gathered a variety of critical onshoring lessons that our clients benefit from:

• Trust but verify: We approach all projects with an attitude of trust while taking the time to verify process data. There is no replacement for being methodical and ensuring that both teams are convinced of a process’s performance and a product’s quality.
• Avoid the shortcuts: It can be tempting, especially en route to Phase 2 and 3 clinical trials, to cut corners to go as fast as possible. In our experience, projects that rush the upfront work tend to go sideways, demanding added time and effort to get back on track. In contrast, clients that let data drive their decision making and take the time and money to improve the process upfront tend to see increased process performance and smoother commercial process validation.
• Implement equipment for ease of transfer: We select our equipment strategically to provide ease of transfer. First and foremost, we employ single-use equipment for a more facility-agnostic strategy than stainless steel processes. We also strive to implement new technologies, equipment, and techniques being used at other CDMOs to promote ease of transferability. One example is centrifugation in cell culture harvesting, which, after working with multiple CDMOs using this technology, we opted to install to enable more seamless transfer and consistent process performance.
• Look at the history: When a new client comes to Avid, we provide them with case studies of similar onboarding processes. For example, if a client is transferring their process from China, we will share insight from previous projects onboarded from China. Our goal is to share our existing knowledge with the client and ease any concerns they may have.
• Provide cost transparency: Some CDMOs may promise lower costs upfront but ultimately incur so many change orders that the bottom line is much higher than initially purported. At Avid, we are transparent about our costs, aiming to minimize change orders as much as possible and guarantee reliability of performance.

How Do I Maximize Success?

Step 1 is identifying a CDMO with the requisite experience to onshore your product with efficiency, ensure continuity where possible, and prepare your process for GMP manufacture. Avid’s ample experience with onshoring has prepared us to identify opportunities for improvement at every stage of the journey, allowing our clients to establish reliable, high-quality biomanufacturing processes that can be scaled for clinical and commercial use.

References

1. H.R.8333 - 118th Congress (2023-2024): BIOSECURE Act. (2024, September 10). https://www.congress.gov/bill/118th-congress/house-bill/8333
2. Clarke, J. (2025, October 14). What tariffs has Trump announced a why? BBC News. https://www.bbc.com/news/articles/cn93e12rypgo