There is a pressure on the pharmaceutical because of the shifting regulatory environment. The FDA in a meeting with the Congress recently has put forward draft guidance attempting to modernize the drug manufacturing. In the suggestions part, the federal agency of the USA i.e. FDA is encouraging life sciences firms to embrace the latest technologies for improving drug quality.
The reason for it is because the poor quality of drugs can lead to a range of failures like contaminated containers, compromised sterility, etc. because of which there is a delay in the product launches. And the delays and risks tend to not reach the patient on time. For example, in the year 2016 66% of product disruptions were the because of the product-specific quality failures and gaps at the manufacturing facilities
So in order to minimize the risk of either occurrence, present life sciences organizations are gradually embracing state-of-the technologies to simplify the complete process from starting to finish. In fact the FDA’s draft guidance is a means to additionally support widespread adoption in the entire industry. However, the problem with unfocused implementation is that it results in disjointed, inefficient processes which collect large volumes of data with fewer contexts. But definitely there is an improved way for firms to enhance their biologics manufacturing process improvement efforts.
External Pressures Encouraging Biologics Manufacturing Process Improvement
The wishes to reduce drug shortages and recalls, combined along with ongoing pressures to minimize manufacturing costs have emphasized quality of big drug batches. Therefore, the industry has begun to move away from batch processing to nonstop manufacturing systems. Like for example, the FDA has approved Johnson & Johnson’s swap to a continuous manufacturing process for its HIV drug. The novel method cuts production time from one month to a day. So appreciation sends a message transition to continuous manufacturing processes to companies.
Johnson & Johnson had spent 5yrs working on their new process whose benefits can be vast. And as explained by them, manufacturing times can also be reduced to a great extent. It even cuts the testing cycle by 80% and waste by a third. Therefore, if companies wish to simplify their workflow; continuous manufacturing adoption should be considered.
Digital Solutions Supporting Biologics Manufacturing Process Improvement
Accepting an incessant manufacturing process requires an integrated technology and this manufacturing method is effective because it removes the breaks between steps and lessens the risk of human error from the start and stop phases that set apart the traditional batch processing. Companies too can act quickly to alteration in demand or even speak quality issues immediately, which helps in preventing drug shortages.
To achieve this, companies even require a method to contextualize collected data and use those rewarded insights to take informed decisions regarding the process. For example, a company can apply an integrated solution to back its biologics manufacturing process improvement efforts.
The digital processes can make possible users to analyze collected data to pinpoint a trend related with a specific ingredient in a bio-process. That information can be utilized to lessen product variability, which can then develop future process quality.
Hence, organizations can even have a look at data associated with conflicting events so as to identify the cause. Nevertheless, in spite of the finest efforts to avoid poor manufacturing quality, accidents keep happening. Continuous biologic manufacturing process improvement allows organizations to identify deviations and rectify them straight away, then waiting for the next batch.
Most importantly, present day life sciences organizations cover the world, needing enhanced techniques of communication.
Therefore, life organizations have no option but to go along with the flow. And with the right technologies, they can succeed.
Source Link: http://accelrys.com/blog/index.php/2016/06/28/how-can-biologics-manufacturing-process-improvement-benefit-from-integrated-digital-solutions-ls/
