Packaging is an important consideration when manufacturing pharmaceutical products. Michael Rooney and Walter Schmid from Foster Wheeler Biokinetics discuss how failure to consider it at an early stage can lead to a more expensive, less-efficient manufacturing process.
When companies think about drug development, the main goal is to create a product that is stable and produces reliable, repeatable results. In order to achieve this outcome, other important considerations can be pushed aside only to cause problems further down the line. One such consideration is packaging.
Some successful products are moisture, light or oxygensensitive, placing tight restrictions on the primary and secondary packaging employed. Products also need to fit into storage and distribution systems, and automated hospital pharmacies, which tend to be specific about the form their packaging takes. Often, existing equipment is not capable of handling a new type of container or closure. Many companies fail to foresee these challenges and face setbacks or unnecessary product costs as a result.
"In some instances, there is an incomplete understanding of what’s required," explains Michael Rooney, senior pharmaceutical specialist at Foster Wheeler Biokinetics. "Designing the packaging and packaging system takes a lot of time and effort. If planning is deferred until too late in the project, you can’t anticipate problems and address them in your design and product costing."
Cost in context
Much of the risk is on the cost side, particularly with generics or low-value products, where the cost of packaging should not eat too much into the product’s profitability. With higher-value products such as vaccines, which can cost up to $100 per unit, the performance of packaging is critical. According to Walter Schmid, team leader and senior bioprocess specialist, manufacturers need somebody to walk them through the manufacturing scenario at the beginning of the process.
"I’ve seen formulators specify very expensive components, like those for a liquid fill for injectables," he says. "They might decide that to solve a stability problem, the best glass, vial and stopper should be used, which might increase the material cost by $1. But if the product can only be sold for $1, the selection of the packaging material adversely affects marketability. In the case of new chemical entities, it’s all about dealing with unknowns. You need to make sure the package is cost-effective, offers the right protection, serves the product function required and can fit into a client’s manufacturing environment. Stability is sometimes only half the issue."
This factor has been further complicated by efforts to prevent counterfeiting. As counterfeiters get their hands on increasingly sophisticated manufacturing equipment, manufacturers have responded by using advanced technologies, such as the serialisation of packages. This is an expensive process, requiring the retrofitting of existing lines and the creation of a substantial data management infrastructure.
"Serialisation of packaging at a unit of sale and use level is one of the more sophisticated emerging technologies," he says. "Particularly with larger companies with more extensive product portfolios, a lot of new coding equipment and IT infrastructure will be required. Also, a lot of clients just don’t have the resources in house to design their own integrated packaging systems. They say to us, ‘all I have is a vial’, so where do we go from here? We can provide not only the equipment, but also the experience in package system design to help a client figure out what they need."
Knowing the market
Foster Wheeler Biokinetics benefits from a global presence, with several centres of excellence that collaborate on engineering projects. This reach also gives the company thorough knowledge of local regulations, the substance of which is a major matter for consideration, particularly in developed markets such as Europe.
"In the US, we can design large, fast production lines for products that can be distributed to the US, Canada and Mexico," Schmid explains. "The EU is different. It has done a great job introducing packaging legislation across all member states, but individual countries still have some specific regulatory requirements. You might manufacture a product packaged and coded in a certain manner that is fine for Poland, but not for the UK. As a result, you end up with a need for substantial line flexibility and often manufacturers turn to manual packaging for small-lot manufacturing."
Increased legislation and the need to keep a lid on costs have also driven a change in CMO strategy. The business has focused on becoming more flexible, as a growing number of big pharmaceuticals companies look to outsource. In addition, many CMOs are pursuing proprietary products as a means of boosting margins. Foster Wheeler Biokinetics can analyse the capabilities of these manufacturers to identify the one most fit for purpose.
"It’s now about finesse – small, cost-effective runs with multiple configurations and formats," says Rooney. "Just like the industry isn’t pushing out blockbuster drugs as often, CMOs are looking to be more flexible and more reactive, often only automating common unit operations. There is a lot more manual packing than there used to be, which requires extra attention."
The manufacturing process is much more complex than it was even five years ago. By factoring in packaging system needs at an early stage, a lot of cost and complexity can be avoided.