IT in Drug Manufacturing
Information Technology enables organizations to work more productively and efficiently. Some of its major advantages include protection of records, quicker communication, and secured electronic storage. Pharmaceutical Software solutions can be implemented faster and also aids industries to satisfy requirements effectively.
As the whole medical industry ventures in a digitally-inclined world, it has been facing numerous technological disruptions that come with this progress. Below are three major technical areas that have been changing the drug manufacturing industry.
Data Integrity. The life sciences and pharmaceutical industry has been dramatically affected by the coronavirus pandemic. With more than 47.5 million infected and 1.2 million lost lives, and those numbers are rising every day, the industry is forced to work non-stop to create, trial, and bring to market a wide range of drugs supporting the treatment and prevention of COVID-19.
However, these efforts are being challenged by a shortage of resources, restrictions on importing API, social distancing protocols at facilities, disturbed and uncertain supply chains, and increasing pressure to manufacture and distribute products as quickly as possible. Yet, it remains critical for pharma companies to maintain quality and compliance and follow regulatory guidelines despite these circumstances.
Unfortunately, insufficient data integrity practices in the manufacturing and testing of pharmaceuticals products, and according to the researchers at Carnegie Mellon University, have resulted in a steady rise in the number of enforcement actions, such as warning letters, import alerts, and consent decrees.
Information Security. Since governments in many countries, especially Asia, do not prosecute cyberattacks very often, cyber attackers and data thieves have become confident in maliciously hacking into pharma IT systems. Electronic thieves and hackers have evolved from juvenile to sophisticated and elaborate attackers, stealing confidential company and employee information, selling it or using it to counterfeit drugs, and committing identity theft or fraud.
Some violations observed within the pharma industry are relatively harmless, such as an employee’s kin or close friend hacking into an HR database after spotting his relative’s user ID and password. However, most intruders do not do it out of curiosity but rather seek to exploit a weakness for profit. Ransomware attacks have been increasing among medical institutions, such as those that are developing vaccines against coronavirus. Researchers have seen an evident rise in sophisticated attacks being made against the medical industry.
Big Data. It takes about 10 to 15 years for a drug or vaccine to evolve from inception to release. And billions of dollars are being invested every year into the discovery and development of new medicines. Still, it usually takes 10-15 years for a drug or vaccine to evolve from inception to release.
According to the 2018 Pharmaceutical Packaging and Processing White Paper, produced by PMMI, the Association for Packaging and Processing Technologies, Research & Development (R&D), investment of a pharmaceutical company involves screening of 5,000 to 10,000 chemical or biological compounds in the quest to find one that exhibits the necessary potential for treating new or existing conditions. But there is also a risk in investing in R&D especially when a drug fails or does not meet regulatory approval.
As a resolution, big data can be of aid in this situation. Using big data to design clinical trials better and predict outcomes that can make manufactured drugs commercially feasible to develop medicines for smaller patient populations. Pharmaceutical companies are looking to big data to reduce costs in research and development and manufacturing.
By collecting data on patient responses to drugs during the clinical trial process and using that data with AI, pharmaceutical manufacturers will be able to reverse engineer which aspects of a patient subpopulation are associated with responses to drugs.
There will be more technological disruptions that will either advance or doom the pharmaceutical industry. Regardless, if this industry continues to utilize new and existing technologies, it will soon master the art of producing high-quality drugs and other products at an efficient speed and secured manner.
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