The pharmaceutical industry is undergoing a groundbreaking shift from small-molecule products to large molecule biological products. Some of the bestselling drugs in Europe are biopharmaceuticals. These types of medicines have the potential to offer personalized and precise treatment. The advantages of biologics compared to chemical drugs are that bio-technically produced medicines are better at targeting the right molecules and are highly efficient in treating serious diseases.
The Growth of Biopharma
The biopharmaceutical market is huge and growing too fast to be overlooked. This rapid growth is due to the wide acceptance of biologics because of their potential to cure formerly uncurable conditions, leading to a high demand for biopharmaceuticals. It is not surprising that big pharmaceutical companies are increasingly concentrating their R&D efforts on large molecule drugs. Today, biopharmaceuticals make up about 20% of the pharma sales with an annual growth rate of more than 8%.
What are the challenges?
Moving from traditional pharma to biopharma brings many challenges. Complexity in manufacturing of biologics, high costs and ensuring efficiency in production are among the important challenges that biopharma must overcome to maintain competitiveness. We are entering to an era where it is becoming fundamentally important to get the right product to the right patient, at the right time and at a fair price. The biopharmaceutical companies that will be successful in tomorrow’s market are those that possess a wide range of operational and technological capacities. Lean, flexible, and efficient manufacturing capabilities are required to cope with this new shift in the industry. While small molecule drugs are generally manufactured in high-volume, high-speed facilities and tend to be used by many patients, biologics on the other hand are targeted towards a smaller population of patients and need to be produced in small batches. Biopharmaceutical companies need to adapt and develop the technologies to efficiently manufacture small batches of biologics.
Transitioning from small molecule products to large molecule drugs means moving from large batch, mass market drugs to small batch, niche drugs. This puts a lot of strains on production, as the conventional manufacturing equipment is inefficient when it comes to small batches because of the long changeover times and frequent formats change. A changeover time that takes 1 or 2 days is not important on a big manufacturing line since the ratio of downtime to production is quite rational. However, it would not be cost-effective to manufacture small batches on a large line, since the changeover time can be longer than the time it takes to make those batches.
Graniten developed its FlexLine Packaging System to help pharmaceutical companies increase their efficiency and reduce their costs for their small batch production. FlexLine Packaging System offers a small footprint design, close-to-zero changeover time with no mechanical change between formats. The machine is built on a modular system using robotics allowing specific production configurations (primary and secondary packaging as well as end of line packing) and the possibility for future upgrades.
One of the global big pharma companies saw a huge potential in this machine, 70% of their orders were below 3 000 packs last year and the percentage is growing yearly. “The current lines are definitely inefficient in managing small batches (…) we spend 50% of the time in changeover activities.” says the system engineer of the site where FlexLine will be installed next year.
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