Nearly nine out of ten prescriptions filled in the United States are for generic drugs. Yet generics account for just 28 percent of pharma revenue. Generics treat large numbers of patients, and the cost is fairly low. On the other side of the pharmaceutical world are high-value biologics and biosimilars – fairly expensive with smaller potential patient populations.
That dichotomy is playing out all over the world, where major pharmaceutical companies have seen the pipeline of blockbuster drugs aimed at the mass market slow to a trickle, replaced by a focus on targeted medicines that treat relatively small patient populations.
That’s uncovered a glaring issue with the pharmaceutical filling lines of today’s drug companies. In short, they’re too big.
The problem with large filling lines
The shift from small molecule drugs to large molecule biologics has had a distinct impact on the pharmaceutical industry, which is shifting from large manufacturing footprints to smaller, more nimble plants.
Let’s say you have a traditional filling line, one capable of filling 400 vials per minute. While it’s filling the drug, it doesn’t run anything else. However, 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 change time may be longer than the time it takes to fill the order.
Targeted medicines, for example, 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, it needs to fill a cartridge, and the next one needs a syringe. Switching from one batch to the next takes time and large filling lines just aren’t as efficient for delivering smaller batches.
SCHOTT iQ PlatformHow to make existing lines more efficient
But rather than devise a new filling line or some other capital expenditure, manufacturers can improve efficiency and flexibility by using ready-to-use containers supplied in an industry-standard tub that works with their existing filling lines. By relying on the standard tub to hold all vials, syringes, and cartridges, manufacturers can easily switch from one container to another.
There are other benefits as well. Nests keep glass containers separate, and reduce the need for human contact, reducing contamination or breakage. These smaller batch medicines tend to be far more expensive than mass market injectables, maybe $500 per dose. Even with the standard industry loss rate of one percent, the cost of broken and contaminated containers adds up.
SCHOTT developed its iQ™ platform to present manufacturers a nest-and-tub format for ready-to-use vials, syringes, and cartridges. Using the iQ platform, manufacturers can reduce their investment costs by up to 40 percent, their operating costs by up to 40 percent, and their clean room space by 60 percent.
Pharma manufacturing has evolved. Smaller, and leaner operations are going to be much in demand. They will give drug makers a pathway to make a small batch of injectable treatments. These can be highly targeted products tailored to individual patient needs, or new drugs that are ready for clinical trial.
Flexible filling lines will also serve the growing biologic market. The key to all of this is the reliance on a global standard – already codified for syringes – to make sure that manufacturers don’t have to worry about packaging components, and can get to the real business of making medicine.