Size matters — revealing how small and flexible means fast and profitable in pharma packaging

Gregor Deutschle, global business development manager for SCHOTT, speaks about how small and flexible means fast and profitable in pharma packaging and he reveals what this shift in manufacturing means for the industry and consumers.

Over the past decade, pharmaceutical companies have seen their drug development pipelines turn from firehoses to dripping faucets. While the days of blockbuster drugs seem to be in the past, each drop from the faucet has surged in value.

High value products – often biologics, targeted medicines for patients susceptible to specialised drugs, and treatments for rare diseases have replaced the blockbuster injectables that kept pharma’s balance sheets healthy. These treatments target smaller populations. And that’s uncovered a glaring issue with their filling lines. In short, they are too big and inflexible.

Consequently, pharma manufacturers are engaged in a fairly massive shift away from bulk filling toward smaller and faster finish-and-fill operations. By relying on proven standards known from syringe filling, the industry can simplify its supply chains and reduce the cost and the number of variables involved in the selection of optimized drug delivery devices. In fact, this tried-and-true nest-and-tub system that has been used by the pharmaceutical industry for decades is the key to true flexibility.

The need to adapt

There’s a continuing trend from small molecule, traditional medicine to large molecule, biotech drugs. A lot of these treatments are targeted. They are not so much the ‘one-drug-fits-all-patients’ blockbuster approach, but a more targeted treatment to address parts of the patient population.

As these therapies are targeted, production runs will inevitably be smaller. This in turn leads to a requirement for pharma manufacturers to adapt their focus on smaller batch sizes.

Sizeable challenges!

Let’s say you have a traditional filling line, one capable of filling 400 vials per minute. That’s a big line, and while it’s filling product, it doesn’t run anything else. When that run is done and it’s time to make another drug, it might take several shifts to change out all the paths that a vial takes throughout the system.

On a large production line, a changeover that takes one or two days isn’t significant because the ratio of downtime to production is fairly reasonable. Filling smaller orders, however, is less cost effective on a big line, because the changeover time may be longer than the time it takes to fill the order.

Previously, for example, there might have been a drug that was made in the tens of millions of pieces. Targeted medicines, however, might have dosage and delivery recommendations that differ according to genetic tests. For one part of the patient population, the company might need to fill a 6-R vial, and then for another patient population or target market, you need to fill a cartridge, and the next one would get a syringe. Switching from one batch to the next takes time.

Nest and tub solution

To assist with the necessary adaptation to smaller production runs and more flexible processes, we at SCHOTT have harmonised the packaging components already in use. In basic terms, offering ready-to-use products in a nest that sits in a tub.

The nest and tub is sealed and one or two bags are sealed around it. When they are transferred into the sterile filling suite, the tubs must be debagged. The lid is removed from the tubs and the nest from the tub. The machine then fills each vial. By making sure the nest and tub are universal to all machines and thus ensuring maximum compatibility, all these steps are easy and thus production efficient.

Large manufacturing lines can also work with nest and tub systems, but they are even more important for small and flexible lines. The nest keeps the glass vials separate, and reduces the need for human operator intervention. Both can introduce contamination or breakage. These smaller batched medicines tend to be far more expensive than mass market injectables, maybe $500 per dose or more. Even with the standard industry loss rate of 1%, the cost of broken and contaminated medicines adds up.

Flexibility is key

Pharmaceutical lines need ready-to-use syringes, vials and cartridges. Pre-filled syringes have been around for decades. Vials rose to prominence in the last five years or so. The International Standards Organisation has standardised the system for ready-to-use syringes.

Rather than develop a whole new standard for vials and cartridges, our nest and tub system relies on the existing one. When we developed our adaptiQ system for nested vials, we worked with the world’s leading manufacturers to develop packaging that is compatible to their existing machinery as well as new cutting-edge developments.

By offering flexible fill & finish machines, we can help accelerate drugs to the clinical trial stage because they provide drug manufacturers with a pathway to create a small batch of injectable treatments. Additionally, these offerings will also serve the growing market of biologics’ use.

However, we also foresee another future, one in which pharmaceutical manufacturers have small and even regional facilities that can instantly respond to changing market demand and adjust their production schedules accordingly. SCHOTT’s solution is well positioned for that as well!