Outsourcing
Compliance with Good Manufacturing Practices is a baseline requirement for contract manufacturers.
Another major flaw highlighted by the Covid-19 pandemic was the vulnerabilities in global supply chains. However, since the height of the pandemic, contract manufacturers and pharmaceutical companies have re-evaluated how best to mitigate these risks. “This includes identifying alternate supplies and balancing cost with quality assurances,” says Gandhi. “The pandemic has really highlighted the importance of contractual terms, transparency, and relationships with strategic partners.”
Industry trends
Pharmaceutical companies are beginning to seek out more collaborative and strategic partnerships with contract manufacturers, and this is no surprise when estimates suggest between half and two thirds of pharmaceutical manufacturing is outsourced. The trend is also reflected in the contract manufacturing market, where companies have been investing heavily in their capabilities not just to manufacture drugs, but to play a role in their development too.
This shift from working with contract manufacturers to working with contract, development and manufacturing organisations (CDMOs) not only allows for improved relationships, but also better long-term strategies. One major benefit is that pharmaceutical companies can put the money they save through outsourcing development into commercialising products once they reach the approval stage. It’s not just development capabilities that contract manufacturers (or CDMOs) are investing in either. The fourth industrial revolution is changing the way their manufacturing process operates too. “There is an increasing focus on innovation and technology to improve quality, efficiency, and transparency in contract manufacturing,” Gandhi explains. “Advanced monitoring systems, data analytics, and automation can prevent errors, reduce variability,
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and provide greater visibility across the end-to-end manufacturing process. Factories of the future leverage these digital capabilities alongside smart facility design.” In particular, the adoption of advanced manufacturing technologies is one of the most significant trends in the sector. The most ambitious goal in this trend is the focus on continuous manufacturing – where pharmaceutical products are produced using a flow approach, without any interruptions. This end-to-end approach is gaining traction due to its ability to produce more consistent quality, shorten production times and allow for better resource allocation. Even without reaching the level of continuous manufacturing, the industry is making better use of artificial intelligence and robotics, both of which are becoming more prevalent due to their ability not only to streamline the manufacturing process, but also improve quality control and efficiency. While these advancements come with criticism due to reduced need for manual labour, the product consistency and quality standards speak for themselves. Of course, there are also trends outside the realm of technology having an impact on manufacturing. As we slowly enter the era of personalised medicine, the development of therapies tailored to individual patient profiles may become more prominent. Contract manufacturers can accommodate this move by introducing more flexible processes that focus on small-batch production and customisation.
Small-batch production not only aligns with personalised medicine, but also contributes to reducing waste and improving sustainability. By producing only what is needed, pharmaceutical companies can minimise excess inventory, ultimately benefiting both the environment and their bottom line. It’s clear that pharmaceutical contract manufacturing is undergoing a transformative phase in an attempt to become more efficient and sustainable, while adapting to the evolving needs of pharmaceutical companies. The core considerations of quality, compliance and reliability will continue to drive decisions about the outsourcing partners companies will use to manufacture their products. But with the benefits of the fourth industrial revolution becoming more tangible, demonstrating the value of new technologies could be the key to long-term relationships with pharmaceutical clients. As contract manufacturers evolve their production processes and look to add services to respond to the shifting priorities of the pharmaceutical market, staying informed about these trends will be essential for companies aiming to maintain a competitive edge and effectively navigate the shifting landscape. ●
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
tomertu/
www.shutterstock.com
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