A Third Model For Outsourcing Development And Manufacturing

By Louis Garguilo, Chief Editor, Outsourced Pharma

Biopharma organizations are often counseled to consider the strategy of “mirroring” your outsourcing activities.

For example, when advancing from research and early development to scale-ups or first GMP batches at your service providers, internally you should hire corresponding professionals (if you haven’t already) able to interact and direct those differing and increasing outsourced operations. This also continues to expand your internal knowledge base.

But what if this were the other way around – your CDMO effectively mirrored your organization?

It’s an idea come to life via a partnership development management organization (PDMO) in Aguadilla, Puerto Rico, that is implementing what it calls a “Mirrored-SME-model.”

In an earlier discussion, Alexandra Ortiz-Rosa, Director, Cell & Gene Therapy Unit, OcyonBio, informed us of a relative abundance (and continuous pipeline) of skilled professions in Puerto Rico. Here she explains a model by which they are being put to work, and how you can avail yourself of them.

 Options Overview

But let’s backup for a moment. Already in the first months of 2023, we’ve detailed three options available for the outsourcing of your drug/therapy development and manufacturing activities.

• The first remains the standard CDMO model, where you find capacity, the requisite instrumentation and equipment, and workers with the knowledge and skills to perform various activities on your behalf.
  • I say “standard" CDMO model, but as we rigorously attest to in these pages, there are a variety of strategic and tactical approaches offered by these service providers that afford sponsors differing opportunities.

• The next outsourcing option we’ve recently covered is the leasing of bridge facilities, or cleanrooms on demand, where you contract to move your internal human resources to external facilities to work on specific projects, and then move your folks back home at the completion of those activities.
  • For now, this predominantly serves as short-term “bridges” between moving to longer-term and expanded relationships with CDMOs, or deciding to build internally. (Or reaching a critical proof-of-concept milestone and selling your program to another biopharma organization.)

• The third option is the innovated partnership development management organization (PDMO) model, which we began to detail in our last editorial.
  • Here you also utilization external facilities (similar to the other two options above), but can choose to use the service-provider’s FTEs and personnel, bring in your own professionals to work autonomously, or blend the two groups of human resources.

Self-Reflection

In our recent conversation, Ortiz-Rosa introduced the PDMO’s so-called “mirrored-SME-model.”

This begins typically when during initial and joint discussions between PDMO and client, one to three project-specific professionals from the sponsor are selected to participate in a tech transfer to the facility. Then the same number of PDMO professionals are selected to “mirror” them.

The combined team is assigned for the complete transfer of the sponsor’s program knowledge, technology, and requisite production skills, in order to get the project up and running efficiently.

To this point, the client onboarding is not so dissimilar to some CDMOs where client personnel are welcome for at least some periods of time during tech transfers.

The difference is when the sponsor in the PDMO model opts for a longer-term, mixed-personnel relationship. The sponsor may choose to have its employees stay on at the facility through the implementation and beyond, which in some cases could span up to a year, according to Ortiz-Rosa.

In other words, if you were to opt for this option as a sponsor, your professionals could work side-by-side with the SMEs you may have helped train to run your processes.

From a different perspective, your incoming personnel can learn alongside the hired SMEs as the project progresses.

“But the whole idea of mirroring originated from our experience with tech transfers,” says Ortiz-Rosa.

“We found the most effective way to transfer technology for a cell or gene therapy program into a clean room space is to sit down with the customer and identify one to three SMEs on their side – people who know the process in and out, and who can come to Puerto Rico for some time to transfer all that knowledge to our team.

“The client arrives and transfers the knowledge over a period of time, basically creating our in-house SME for their purposes,” she adds. Ideally, after a certain period, that in-house SME team can run everything "from the process to the analytical assays, and throughout the lifecycle of the product.”

Or, as mentioned above, you can opt to keep your professionals involved on site for as long as you prefer, contingent upon certain contracts and stipulations.

“That's one of the advantages of ‘partnership,’” says Ortiz-Rosa. “If sponsors want to have staff physically here throughout the duration of their project – as long as that is – it can be arranged.”

Of course today there are many forms of service providers with person-in-plant (PIP) arrangements that allow sponsor personnel to stay on hand during operations. However, the "mirror" application runs deeper: A virtual sculpting of the service-providers skilled workers to your purposes.

The chips in the mirror, though, could be the lack of time for “training” resources, or the lack of internal SMEs per se. Some might insist they go to a CDMO “because they have the experts and we do not.”

So again, it is a different model, not for everyone, but worth investigating for many. 

Added Reality

Time will tell if this catches on, but let’s for the sake of further discussion assume the more palpable option for sponsors interested in this mirroring model would be to arrive at the new facility, train the facility's SMEs and perform the tech transfer, then return to home base.

In this case, says Ortiz-Rosa, sponsors can continue to feel close: Less mirror, and more an “element of augmented reality [AR], an option included within the partnership.”

“Once the client’s SMEs fly back home, they are able to assist and remain involved with technology such as AR devices our operators would use in-house as they perform their operations.”

I ask Ortiz-Rosa to clarify whether this is something for the future, or actually available today.

“We are currently implementing some trial runs, and we are close to full implementation,” she replies.

So there you have it. Outsourcing with mirrors, and goggles for augmented reality. There’s much to keep a (discerning) eye on as models to serve you evolve.

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Next up: Do not miss the discussion with Alexandra Ortiz-Rosa on the role of women in biopharma