The tricky challenges of new drug development and packaging

The journey of specialty drugs and biologics to the mainstream is littered with roadblocks and detours. In addition to the small margin for error, any unintended bioburden due to packaging failure increases the risk of drug contamination that can harm patients. Additionally, regulatory guidelines differ by country, and these rules sometimes prevent biologics from being sold, if manufacturing and filling is completed abroad.

Few pharma companies have already invested in small production facilities throughout the world to match demand while satisfying regulatory guidelines. But because these biologics and specialty drugs are high value and produced in small batches, many manufacturers are outsourcing the container and component processing to achieve higher efficiency without costly investment. Together, these two scenarios have raised the profile of RTU packaging.

Reducing risks in a high-stakes market

Developed as a form of risk reduction, RTU packaging grants manufacturers the ability to produce small to medium drug batches – biologics and specialty drug compounds in particular – without implementing wholesale changes to a manufacturing line. RTU packaging also preserves the sterility required by regulatory standards.

As the rules surrounding sterility for injectable drugs grow more complex, and as costs increase, many drug manufacturers are outsourcing the job of sterilizing and filling vials, syringes, and ampoules to their packaging partners. That lowers the total cost of ownership for manufacturers and boosts efficiency and safety as more RTU packaging is brought online.
The industry-standard nest and tub is one example of how RTU packaging for vials has evolved. Traditional vial packaging was a bit of a free-for-all, as vials were un-nested and moved freely through a packaging line. This movement of vials increased the risk of scratches and breakage.

But in new RTU solutions, such as SCHOTT’s adaptiQ®, vials are nested in the standard tub throughout the filling process, and come onto the line sterilized and primed for filling. The entire tub, which can hold up to 100 sterile vials, can be loaded onto production lines without reconfiguring or adjusting the mechanics of the system. This standardization allows packaging manufacturers to easily transition from large-scale production of a drug to a low-volume filling request – again, great for low-volume, high-cost drugs. Plus, the system can adjust to fill vials to specific volume based on the drug compound.

Ready for the trillion-dollar industry

Global spending on medicines will hit the trillion dollar mark by 2017. Spending on specialty pharmaceuticals will rise to $193 billion in developed nations, and $43 billion in pharmerging nations – developing countries where use of pharmaceuticals is quickly growing – over the next few years, IMS Health found.

That’s put the pressure on pharma packaging manufacturers to develop vials and syringes, and the method of processing, for these high-value drugs. The result is RTU packaging that ensures accurate and safe filling for biologics and specialty drugs.

As specialty drugs gain market share, RTU and other packing solutions will grow in importance to ensure drug safety and the long-term health of this growing segment of pharmaceuticals.