What if we could deliver the right treatment to the right patient in a simple and easy way? Precision medicine enables the delivery of personalized medicine by joining genetics, biology and medicine. In the past, we used to understand the symptoms of a disease without really understanding why those symptoms arose. Precision medicine enables a precise diagnosis of individuals by determining what factors such as genetics, diet and lifestyle caused the problem. With the use of this information, it becomes possible to design the most effective and customized treatments.
Benefits of precision medicine
Precision medicine, also known as personalized medicine, seems to have an important impact on improving many aspects of health care treatment methods and the health of patients. The modelization of the human genome seventeen years ago has helped in understanding the cause of many diseases and became an essential component of precision medicine. Based on the knowledge of the patient’s genome and specific lifestyle and environmental aspects, precision medicine enables a personalized diagnosis and treatment where the “one-size-fits-all” approach becomes irrelevant.
One of the main benefits of precision medicine is focusing on prevention instead of reaction. Patients now have the possibility to learn whether they are more likely to develop a certain disease in the course of their life. It therefore allows them to monitor their health before the appearance of any symptoms and to implement preventive measures to their lifestyle. Precision medicine is also allowing medical professionals to reduce the risk of adverse drug reactions. Because each individual responds differently to a certain treatment, some patients may develop side effects related to a certain drug. Genetic information can be used to prescribe the right dosage and medicine for a patient lowering the risk of potential side effects. This in turn contributes to decreasing healthcare costs through reducing the trial-and-error treatments.
Challenges of precision medicine
Although the emergence of precision medicine is leading to tremendously better treatments for patients, the high costs of pm remain the biggest challenge for its full implementation. Expenses related to R&D, DNA sequencing, different genetic tests and orphan drugs are extremely high. The costs are significantly large and the price to the patient is therefore high since the medications are targeted to very specific populations. On the other hand, many people are taking drugs and undergoing treatments that are not working for them, thus if we could save on costs of improper medications we would cut down on a lot of unnecessary expenses.
Implications to pharmaceutical production
Whilst rare diseases were overlooked in the past few years, with the advent of precision medicine and gene therapy a growing interest arose in the development of “niche drugs”. Many pharmaceutical companies are now investing in drugs that are targeted to a specific category of patients. There are increased complexities and costs involved when it comes to manufacturing drugs for a small patient size. Although the costs to manufacture targeted medications can be passed down to the patient and third-party payers (such as insurance companies), their use is constrained to a quite small category of people who have the same disease genetic markers, thereby decreasing the margins for pharmaceutical companies. Furthermore, the production of these high value tailored drugs necessitates a high level of flexibility and agility in manufacturing. Hence, producing these small volume niche drugs requires pharmaceutical companies to start using new production methods and a better suited manufacturing equipment in order to maximize efficiency and reduce waste.
Manufacturing small batches of personalized medication
When it comes to mass produced drugs, a changeover time of several hours is not problematic because the downtime is relatively reasonable compared to production time. However, manufacturing small batches in a big capacity line is unprofitable and inefficient because the changeover time can be longer than the production time.
Graniten is aware of the production and packaging challenges of personalized medicines. Graniten’s Pharma Business Area Director Fredrik Sollenby said “I think the biggest challenge for pharmaceutical producers is they have to really take a holistic picture of their production processes. Before, they have been investing in high speed production lines, which is very good in producing blockbuster medicine, but as batch sizes are shrinking, speed is getting less important and having a changeover time of maybe several hours just won’t be acceptable anymore. Instead pharmaceutical producers should complement their existing big capacity lines with extremely flexible lines that are focusing on very short change over times and thereby increasing their overall efficiency of the entire production.”
Flexible Packaging Line
Graniten developed FlexLine – a flexible packaging line equipment to help pharma manufacturers increase their efficiency and reduce their costs when it comes to producing medicines with small order sizes. FlexLine Packaging System enables running small orders in one production line with minimum changeover time (close to zero). The small footprint 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 of upgrades. Using this fully automatized equipment together with multiple inspections and quality control systems, manufacturers can cut down their production operators which in turn contributes to eliminating human errors.
Pharmaceutical production has changed a lot in recent years. The demand for smaller lots is increasing and this trend is going to continue in the coming years due to more customized and tailored medications towards small groups of people. Flexible production lines will help pharma manufacturers in increasing their efficiency and reducing their costs when it comes to producing niche drugs.
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