Thinking October 29, 2026

Late-stage requests: what does flexibility actually look like in contract pharmaceutical packaging?

Josh Lowth
By
Josh Lowth Category Marketing Manager - Pharmaceuticals and Drug Delivery

Flexibility is a word often used by CDMOs to describe pharmaceutical packaging services. But in practice flexibility is hard to deliver.  

For Ensera, flexibility often means responding when a customer’s requirements change late in a pharmaceutical product’s commercialization journey. An artwork update may be needed close to launch. Forecast demand may move from one market to another. Volumes may change across several SKUs, each with different packaging or labeling requirements.

By then, materials may have been ordered, packaging may have started and delivery dates may be fixed. Even a relatively small adjustment can disrupt the schedule or leave packaged stock unsuitable for its intended market.

This is when flexibility, and the ability to manage it effectively, becomes valuable.

Working with changing requirements

Secondary packaging plans are based on the best information available at the time those plans are generated. But of course, that information does not always remain fixed. When circumstances change, so too must the packaging plan. Because secondary packaging is a downstream activity, there’s usually little wriggle room on very tight timelines to accommodate a change.

To complicate matters, each request has the potential for multiple ramifications. The team must consider the packaging process, available materials, quality requirements and delivery schedule before agreeing on a way forward.

Being flexible means having the expertise, experience, infrastructure and resources to make that assessment quickly, then putting the revised plan into action.

Finding a workable solution

Late changes sometimes require an approach outside the original packaging process.

In one recent project Ensera supported, packaged inventory required an updated label before it could be released. Removing the existing labels would have added cost and taken more time, so our technical team developed an over-labeling process instead.

The replacement label was non-standard and had to be positioned precisely. The team developed a placement aid and a manual application process, trained the operators and introduced adequate checks to confirm that each label had been applied correctly.

Additional shifts were then assigned to complete the work within the required schedule.

The flexibility and value of this example lie in the response. The team understood the problem, established a controlled process and organized the resources needed to deliver it.

Speed is part of flexibility

A packaging partner may be willing to accept a change but unable to implement it within the customer’s timeframe. For a product approaching launch or already in commercial distribution, that delay really matters.

Late-stage requests usually come with a deadline, not just because they happen late in a program, but because they are often triggered by real and tangible supply issues which risk impacting patient and business outcomes. Stock may be needed at a distribution centre. Product may be running low in a particular market. A launch date may leave little room for the packaging schedule to move.

Responding effectively requires more than adjusting an existing production plan. Additional work is almost certainly needed to review any proposed solution, source new materials, complete additional training and reorganize shifts, all while maintaining the necessary quality oversight.

In the over-labeling project example, the new labels arrived over a weekend. They were received and inspected, and a test run was completed to establish the expected output. Only then could the production schedule be adapted to meet the customer’s delivery requirement.

Without that speed, the technical solution would have had less value in the sense that it would not in itself have derisked the release date.

Mindset and infrastructure built to adapt

Ensera supports secondary packaging programs involving vials, pre-filled syringes and autoinjectors, including projects with multiple markets, SKUs and varied volumes.

The ability to accommodate late-stage requests to already-complex programs requires a unique mix of flexibility across mindset, process and infrastructure.

Our team’s passion for problem solving is underpinned by aligned capabilities and processes across our global sites, which are also inherently modular – making adaptations easier and quicker to implement.

It’s a combination which is particularly well suited to time-critical work that does not fit a high-volume, fixed-format model. It’s one reason we’re adept at supporting biosimilar and rare disease drug programs to launch and scale commercially.

Every proposed change must still meet the applicable quality and regulatory requirements. Flexibility does not mean working around those controls. It means finding a practical way forward within them.

Plans almost inevitably change. Late-stage requests will often happen. A flexible secondary packaging partner helps customers understand the implications, respond quickly and keep product moving.

If you need more flexibility from your packaging partner, then get in touch, we’d love to hear about your next project.

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