CDMO Facility Design: Balancing Flexibility with Complexity

FUJIFILM’s Jason Goodwin discusses how CDMOs can avoid “overpurchasing” manufacturing capabilities, choose partners with a long-term view and keep equipment practical for the teams operating and maintaining it.

As drug pipelines diversify, contract development and manufacturing organizations (CDMOs) have to decide how much flexibility to build into new manufacturing facilities. Supporting different products and manufacturing configurations can expand what a facility can handle, but additional flexibility can also increase equipment complexity, changeover time, and cost.

In this exclusive Xtalks Spotlight feature, Jason R. Goodwin, Director of Drug Product and Finished Goods Process Engineering, Automation and Commissioning, Qualification and Validation (CQV) at FUJIFILM Biotechnologies, discussed how CDMOs can find a practical range of flexibility.

From equipment selection and supplier relationships to gloveless sterile isolators, Jason explored how decisions made during facility design can support current manufacturing needs while leaving room for future products.

Designing Flexible CDMO Facilities for Changing Pipelines

A new manufacturing facility must support products in place today while accommodating changes in the pipeline over its operating life. The equipment needs sufficient flexibility to support different manufacturing requirements while still being practical for the people who operate and maintain it.

“One of the most important considerations is to determine the ability to be adaptable,” Jason said.

A system capable of handling an extremely wide range of processes or formats may look useful during facility planning, but each additional capability can introduce equipment components, procedures and operating requirements.

“There’s a balance of adaptability, flexibility and also complexity,” he said.

The question is how much adaptability is useful before the facility becomes more complicated to operate.

Vial Filling Shows the Limits of Flexibility

Jason used vial filling to illustrate where that trade-off becomes more concrete. A filling line could theoretically be configured to accommodate a very wide range of vial sizes. In practice, supporting every possible format may add little value if expected manufacturing needs fall within a narrower range.

“If we’re talking about vial filling, for example, we can’t fill the entire spectrum from 2R to a hundred. That doesn’t necessarily make sense,” Jason said.

Instead, CDMOs can define a practical range that supports current manufacturing needs while leaving room for future products.

Additional flexibility may require more equipment components and more complicated changeovers when a line moves from one product format to another. Each added step can increase the time and cost associated with switching configurations.

Jason summarized the risk simply: “You can design a piece of equipment or a facility to do everything, but in that same consideration, it does everything, but it doesn’t do it well.”

In other words, additional flexibility can eventually work against efficiency.

Choosing Equipment for Flexible Manufacturing

The equipment selected for a facility needs to support current manufacturing requirements while allowing for changes in product configurations and manufacturing needs over time.

“Also important when you’re determining the technology and automation is partnering with the right firm or right manufacturer of the equipment that has that same mindset on how to handle current needs and future needs,” he said.

Jason added, “If that partner doesn’t have the mindset, they just want to sell you something that’s not the right partner.”

Equipment flexibility also depends on whether machinery can continue to be supported, modified and integrated as manufacturing requirements change.

Those decisions can affect technology transfer as new products enter the facility. Equipment also has to fit into the broader automation strategy, work for manufacturing teams and support the formats the facility expects to handle.

Going Gloveless in Sterile Manufacturing

In sterile manufacturing, regulatory expectations influence technology choices. Regulators, including the FDA and European Medicines Agency (EMA), continue to scrutinize how manufacturers control contamination risks when producing sterile medicines.

“When we talk about emerging technology, we also talk about emerging regulations,” Jason said. “As regulations come out, either from the FDA, EMA, different regulatory bodies, they put continued more scrutiny on how manufacturing facilities manufacture sterile products.”

Manufacturers are also looking at technologies that place more separation between operators and sterile processes.

Gloveless isolator technology is an area to watch. Traditional systems allow operators to interact with the process through attached gloves, while gloveless systems aim to reduce operator intervention even further.

“First, they started out with gloved isolators and now moving to gloveless isolators. So that’s something that we definitely as an industry need to keep our eyes on,” he said.

Isolators create a controlled barrier around sterile manufacturing operations.

Jason also emphasized how established an equipment supplier is and whether its technology is already being used in the field. He said manufacturers should consider whether a supplier has “a lot of units out there in the field,” particularly when assessing emerging technologies that may still be developing in their implementation.

Avoiding “Overpurchasing” in Facility Design

Adding more equipment configurations can expand what a facility is capable of producing, but it can also increase capital requirements, lengthen equipment changeovers and introduce manufacturing inefficiencies.

“So the key takeaway for this is balancing flexibility with complexity and how do you deliver to your customer the flexibility that they need, but not overpurchasing that where it costs so much to manufacture the equipment and manufacturing facility,” Jason said.

By setting realistic limits on flexibility, CDMOs can support the capabilities customers need while keeping equipment usable, maintainable and efficient in day-to-day manufacturing.

This article was created in collaboration with the sponsoring company and the Xtalks Editorial team.