Today’s shifting regulatory environment continues to exert mounting pressure upon the pharmaceutical industry. In a recent meeting with Congress, the FDA presented draft guidance seeking to modernize drug manufacturing. The suggestions encourage life sciences firms to adopt emerging technologies to improve drug quality.1 Poor quality can lead to costly recalls stemming from a variety of failures such as compromised sterility, mold in manufacturing areas and contaminated containers. It can even result in delayed product launches. In addition to the potential health risks, these drug delays and recalls contribute to shortages, which can prevent life-saving drugs from reaching the patients who need them.
In 2012, 66% of product disruptions were the result of product-specific quality failures and lapses at manufacturing facilities. To minimize the risk of either occurrence, today’s life sciences organizations are increasingly adopting modern technologies to streamline the entire process from start to finish. The FDA’s draft guidance is, in part, a means to further encourage widespread adoption throughout the industry. The problem with unfocused implementation, however, is that it can result in disjointed, inefficient processes that collect large volumes of data with little context. Surely there is a better way for firms to boost their biologics manufacturing process improvement efforts.
External Pressures Are Fueling Biologics Manufacturing Process Improvement
The desire to reduce drug shortages and recalls combined with ongoing pressures to minimize manufacturing costs has emphasized quality of large drug batches. As a result, the industry has begun to shift away from batch processing to continuous manufacturing systems. For example, the FDA approved Johnson & Johnson’s switch to a continuous manufacturing process for its HIV drug. The new method cuts production time from one month to one day.2 The approval sends a clear message to other companies: transition to continuous manufacturing processes.
While developing new manufacturing protocols can take time—Johnson & Johnson spent five years working on their new process—the benefits can be immense. As demonstrated by Johnson & Johnson, manufacturing times can be reduced dramatically. It also cuts the testing cycle by 80% as well as waste by a third.3 If companies wish to streamline their workflows, then continuous manufacturing adoption should be seriously considered—especially in light of the FDA’s support.
Digital Solutions Support Biologics Manufacturing Process Improvement
Adopting a continuous manufacturing process requires integrated technology. The manufacturing method is efficient because it eliminates the breaks between steps and reduces the risk of introducing human error via the start and stop phases that characterize traditional batch processing. Companies can respond quickly to changes in demand or to address quality issues immediately, which prevents drug shortages.
To accomplish this, they need a way to contextualize collected data and use those gained insights to make informed decisions about the process. For instance, a company can implement an integrated solution to support its biologics manufacturing process improvement efforts. The digital processes can enable users to analyze collected data to pinpoint a trend associated with a specific ingredient in a bioprocess. That information can be used to reduce product variability, which can then improve future process quality.
Along those same lines, organizations can look at data associated with adverse events in order to identify the cause. After all, despite best efforts to prevent poor manufacturing quality, accidents do happen. Continuous biologics manufacturing process improvement allows organizations to pinpoint deviations and correct them immediately, rather than waiting for the next batch.
Most important of all, today’s life sciences organizations span the globe, requiring improved methods of communication. For example, the facility making Johnson & Johnson’s HIV drug is located in Puerto Rico. But within the last few years, the FDA has demonstrated that it will hold companies responsible for lapses found in both CMOs and manufacturing plants located in other countries. Because of this, biologics manufacturing process improvement requires technology that supports collaboration and enables users to share information with one another instantly and effectively.
The FDA shows no signs of easing pressure on the pharmaceutical industry. From maintaining quality to continuous biologics manufacturing process improvement, life organizations have no choice but to rise to the occasion. But with the right set of technologies, there is no doubt they can succeed.
BIOVIA offers digital solutions tailored for the specific requirements of today’s life sciences organizations. The BIOVIA Manufacturing Analytics solution is one part of a larger digital suite for biotherapeutic companies. Its features enable the ongoing performance verification required by continuous manufacturing, foster collaboration within an organization as well as its external partnerships and identify and reduce sources of variability. Its ability to offer real-time data access and analytics to contextualize collected information help support compliance and product quality.
1 “New FDA Guidance Advances Pharma Manufacturing Tech,” January 8, 2016, http://www.law360.com/articles/744106/new-fda-guidance-advances-pharma-manufacturing-tech 2 “FDA urges companies to get on board with continuous manufacturing,” April 14, 2016, http://www.fiercepharma.com/manufacturing/fda-urges-companies-to-get-on-board-continuous-manufacturing 3 “Modern Manufacturing Comes of Age,” June 2, 2016, http://www.pharmtech.com/modern-manufacturing-comes-age