The pharmaceutical industry is shifting from producing drugs for the masses to high-value treatments.
Manufacturing life savingdrugs in low volumes complicates the manufacturing process as the latter is just as rigorous and time-consuming as the mass production workflows. Low volume production faces challenges because there are fewer batches for GMP validation, and supply chains are shorter.
Pharmaceutical manufacturers must set up faster production lines, accurately collect batch data, and respond to fluctuating product demands to maximize profits. Pharma 4.0 ensures that conveniently.
Precision medicine (or personalized medicine) is a term used for treatments tailored to an individual’s predicted response to medication. It is based on previously done clinical trials and the patient’s genetic information.
With increasing regulations, finding new ways for people to learn complicated tasks quickly and efficiently is essential. Switching to digital applications will help pharmaceutical manufacturers train their workforce effectively at a lower cost.
You can simulate even fundamental production processes to train workers in life-like working scenarios.
These applications will collect data and allow employers to take corrective actions for improved training efficiency.
Pharma manufacturing is shifting from batch production to continuous manufacturing. Roots Analysis conducted a study on this manufacturing technology, which showed that the technology could reduce manufacturing costs by 15-30% while bringing down workforce costs by 50-70%. It also reported 40% less power consumption, reduced footprint by 50-70%, and reduced product deviation to 50%.
Increase in cloud adoption
Cloud infrastructure helps ensure data integrity while ensuring that information flows seamlessly across a product’s lifecycle.
Big Data for predictive measures
ISPE’s Pharma 4.0 maturity model focuses on smart drug production facilities as an end goal of digitization.
For predictive quality measures, the facility must process large data sets accurately and provide production insights using AI and machine learning.
Single-use technologies and facilities
Single use facilities and technologies are providing low-cost pre-clinical and clinical manufacturing solutions.
These require minimal investment to generate revenue and help save costs. Single-use facilities can manufacture multiple products using disposable technology in place of stainless steel equipment.
Digitization of paper processes and documentation
By implementing new technologies such as AI and IIoT in tandem with their existing systems for record keeping, pharmaceutical manufacturers can maximize efficiency while improving visibility on all levels.
Resource Person: BARBARA PIROLA