Pharma Trends—From Biologics for Niche Patient Populations to Isolators and Containment for HPAPI Manufacturing

As medicine spending continues to increase, there is a lot of expectation and pressure on the pharmaceutical industry not just to develop new drugs but also to ensure the quality of their products. But challenges such as patent expiries and the death of blockbuster drugs in an increasingly cost-constrained marketplace mean that players both big and small have to adapt with the changing trends if they want to survive and thrive. 

Biotech boom, niche markets, and a smaller batch size

One of the biggest trends is the move towards biotechnology and personalized medicine, notes Christian Treitel, head of pharma business development and product management at Bosch Packaging Technology. Small-molecule drugs that are chemically synthesized using predictable processes are being replaced by larger, more complex biologics that are produced in living cells and often consist of heterogeneous mixtures. The structure of a chemical API is independent of the manufacturing process but biologics, on the other hand, are defined by the exact manufacturing process, which can be difficult to control from the starting material to the final drug product.

“While this shift opens up new possibilities in medical diagnosis and therapy, we see batch sizes becoming smaller, derived from the need to treat orphan diseases that affect only a small population of patients worldwide,” says Treitel. FDA has played a crucial role in facilitating the development of orphan drugs through its fast-track program. As a result, the industry is moving away from the one-size-fits-all model and investing more into the development of targeted therapies and finding cures for niche diseases. “The researchers embrace it,” says Treitel, “because there are many areas where you can tap on the potential of targeted therapies; however, for the manufacturers, the complexities of production can be a challenge.”

Smaller lots mean more frequent changes, Treitel points out, and changeover takes time. “You have to clean your equipment,” he says, “and then, there is also the additional task of documentation because it is important to make sure that everything is properly documented.”

According to Treitel, customers are now looking for solutions to manage the complexities of modern drug manufacturing, including fast changeovers. “The aim is to make changeover times shorter,” he says. “Basically, you want it to be faster and more convenient for the operators, which is very important.” The new Manesty TPR tablet presses-TPR 200 (for small to medium batches) and TPR 700 (for high production volumes)-from Bosch, for example, have been designed for fast product changeovers, easy cleaning, and simple operation. 

High potency drug manufacturing, isolators, and containment systems

Another key trend is the rapid growth of high potency APIs, which require specialized containment to ensure that both operators and the environment are protected from exposure, observes Treitel. “You want to really make sure that the product is safe and that the operator is safe.”

There has been major breakthrough in isolator and containment systems and pharmaceutical manufacturers recognize the advantages of these technologies (e.g., improved aseptic environments and lower operational costs) compared with conventional clean rooms. “Liquid filling lines are becoming more complex and require integration of the filling machine with an isolator and subsequent machines [such as a freeze dryer or an overseal capping machine],” says Treitel. The challenge is to ensure safe functioning of the interfaces, but at the same time, keep the overall controls system simple and be able to easily operate the individual components. Bosch offers everything from a single source, according Treitel.

For an industry that is highly regulated, quality remains a top priority. “FDA is getting stricter and really checking on pharmaceutical facilities. You often hear of warning letters being issued,” says Treitel. “This means pharmaceutical manufacturers have to work on their quality procedures, and they are looking for support from us-for example, if you are looking to replace your equipment and want certain things to be automated so that manual intervention and human errors can be reduced.”

The relationship between supplier and the pharmaceutical industry is changing, observes Treitel. “As a supplier, it is no longer about supplying single machines but helping the customer to integrate the different pieces of equipment and providing support in implementing projects.”