Somewhat misguidedly, pharmaceutical packaging is often overlooked or assumed to be a commodity service that “anyone can do,” says Scott Houlton, CEO, CSM (a Clinigen Group company)
Scott Houlton, CEO, CSM
The reality is that a significant number of product issues are triggered by packaging problems that could have been avoided with proper planning.
These challenges can have huge financial and reputational ramifications. Today’s medicines are becoming more complex and address a vast breadth of illnesses.
And although advances in novel medicines are helping a great number of patients, managing the supply chain is becoming increasingly complicated. In particular, two significant trends are currently impacting pharmaceutical packaging requirements.
Specialised medicines that target smaller, more specific patient populations: Medical treatments and the drugs that patients receive are becoming increasingly personalised. This means that the packaging industry needs to adapt to smaller production runs and accommodate the flexibility required to cost-effectively switch between projects while maintaining high quality standards.
The number of medicines that can be packaged in large bulk runs and used for millions of patients has been reducing as we move to more specialised medicines. Many packaging companies can operate at a scale and level of automation that’s appropriate for these declining numbers of large production runs. But, the equipment and processes are not well suited to smaller packaging runs that require more agility.
Cold-chain requirements for new medicines: Many new products need to be refrigerated or frozen to protect the efficacy of the medicine. These products must be packaged, stored and shipped under proper temperature conditions, which increases the costs and potential risks to products arising from poor packaging.
The infrastructure required to ensure temperature compliance throughout the packaging process requires additional capital from vendors to keep pace. At the same time, the packaging required to protect these products is becoming more complex and expensive. This is especially true for some of the cell and gene therapies that require ultra-low temperatures.
Although packaging may not be the first factor to be considered when developing new medicines, it can cause great disruption if not handled properly.
Whether it’s a new medicine progressing through clinical trials or an existing medicine that’s already on the market, companies should look at how to optimise the packaging to increase quality compliance and the financial success of a product.
Look for experienced providers that have demonstrated a track record of success and are investing in forward-looking trends. Also, look to work with a vendor that is appropriate for your product. If it is still in clinical trials, then partner with a clinical packaging expert.
If your product is highly specialised, partner with someone that has the expertise and track record in small-volume packaging. Finally, just like anything in life, the more planning you put into something, the better the likelihood of success.