Times are changing, and with it, the ways the pharma industry wont to operate also are changing. The so–called ‘’conservative’’ pharma manufacturers are now looking beyond the normal manufacturing model, exploring new avenues to accommodate unexpected sales forecasts and little volume production. As novel drug delivery therapies are evolving with time, pharma manufacturers now need manufacturing capabilities that are versatile enough to accommodate the market’s uncertain requirements and are more responsive. Flexible manufacturing is emerging as apt solution which will overcome these challenges successfully.
Why flexible manufacturing
Traditional manufacturing setup comprising different equipment pieces for various processes are not any longer enough to satisfy the assembly requirements of latest drug products with small volume. Not only is that this mode inefficient, but it also involves more financial and physical resources. Also, the subsequent trends emerging within the pharma landscape demand a flexible approach towards manufacturing to realize more efficiencies.
Fast-track drug approval programs – Orphan drug development is currently hip due to the incentivisation by the regulatory agencies, the general expedited drug approval process, and therefore the exclusivity of those molecules. The shortened clinical development phase means the sponsors and CMOs must complete the chemistry, manufacturing and controls development, scale-up, process validation, tech transfer, and stability testing rapidly after the initial regulatory approval is obtained. to succeed in the market first is one more reason why pharma companies aim to quickly conclude their clinical and formulation studies.
Commercialisation of biopharmaceuticals – within the past few years, the demand for biological molecules, immunotherapy, cell and gene therapy has increased significantly. However, manufacturing such biopharmaceuticals on a bigger scale remains a challenge for several manufacturers due to the shortage of previous diary and limited commercial success.
Unpredictable sales forecasts – The new drug delivery therapies, including orphan drugs and biopharmaceuticals, are highly potent and are usually targeted to alittle patient group. To manufacture such small volume, expensive drugs require a versatile production setup. Further, forecasting the ultimate sales volume of such products is sort of a challenge and involves volatility.
Need for a balanced approach for the stakeholders – Currently, an outsized number of pharma companies outsource their products through CMOs, and therefore the uncertainties in market demand can affect both of them. Sponsors can find yourself in either oversupply or undersupply of the finished product to the market, whereas CMOs can lose on the new opportunities due to the cash engaged in costly goods and expensive inventories. A middle ground is required to supply favourable results to both the stakeholders.
Different approaches to flexible manufacturing
Modular manufacturing
Many pharma companies are choosing modular manufacturing capabilities to supply a good sort of products from one facility. Such an approach offers several advantages, like accelerated equipment commissioning, faster changeovers, high versatility, and improved overall equipment effectiveness (OEE). The ‘’ballroom’’ concept of modular manufacturing involves employing a large manufacturing area with no fixed equipment. the prevailing facility is weakened into modules to facilitate standardisation, simplified processes, re-use of styles , and actual modules in several implementations. The ballroom concept provides many benefits like plug-and-play functionality, lower capital costs, alittle manufacturing footprint, and reduced need for dedicated cleanroom space. Another concept of modular manufacturing is prefabricated manufacturing pods. These podular equipment systems are movable, faster to create , and may be assembled into multiple configurations.
Data-driven manufacturing
The evolution of commercial revolution 4.0 is shifting the paradigm of traditional pharma manufacturing. The ‘’big data’’ and ‘’IoT’’ platforms provide excellent opportunities to the pharma manufacturers to convert the routine operational data into valuable insights and intelligence. supported this data , pharma companies can adopt proactive management mode and develop new strategies to optimise production and mitigate risks. With real-time process visibility, manufacturers can control the operations more efficiently and do better planning.
Single–use manufacturing – This technology has proved invaluable for manufacturing biopharmaceuticals. Single-use bioreactors are relatively quick and straightforward to put in and are now widely replacing the normal large steel-tank bioreactors. The fluctuations within the market demands are often easily accommodated by expanding or reducing the capacity of single-use bioreactors during a timely manner. Product changeovers and cleaning are faster than steel tanks, thus allowing the rapid start of a replacement production batch.
Continuous manufacturing – Compact-scale, capable of integration with in-line process analytical techniques, and highly adaptable, continuous manufacturing is becoming quite popular amongst pharma manufacturers. The inherent flexibility of continuous manufacturing allows an outsized quantity of product manufacturing within a way lesser time than a standard setup. Pharma manufacturers can supply the merchandise in response to just-in-time market requirements rather than maintaining extensive inventories to satisfy the spikes in demand.
The way forward
The diverse, complex product portfolios and unsure , volatile market scenarios have forced pharma manufacturers to think about another factor along side time and price – flexibility. Fortunately, the progress in technology and therefore the rise of IoT platforms have provided the pharma industry enough means to develop new strategic manufacturing concepts that might meet the present challenges. Flexible manufacturing definitely has the potential to accommodate the longer term demands of the pharma manufacturing found out and take it to subsequent level with outstanding results. the sole question is what proportion the pharma industry is prepared to embrace this new approach.
References
https://pharma-trends.com/2021/04/05/flexible-pharma-manufacturing-need-...