Digitalization to Improve CDMO Value Propositions
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Digitalization to Improve CDMO Value Propositions

Pharma Tech Outlook | Tuesday, January 03, 2023

Contract manufacturing and development organizations (CDMOs) are well underway in the fourth industrial revolution, and CDMOs are already embracing digital manufacturing.

FREMONT, CA: The pharmaceutical industry is speeding up its efforts to make its production methods more efficient and consistent, and it's about time. Multiple factors combine to help and force the pharmaceutical industry to change.

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COVID-19's effects on the global supply chain showed how badly the pharmaceutical value chain network needs disruptive technologies to make it more flexible and resistant. The ISPE's Pharma 4.0 framework and the FDA's Advanced Manufacturing Initiative promote the benefits of adding Industry 4.0 capabilities to the pharmaceutical sector. Together, these factors create a chance that has never been seen before to improve the reliability, quality, and cost-effectiveness of pharmaceutical product supply when and where patients need it while also meeting sustainability goals.

This digital transformation, which is already happening in industries like energy and chemicals, is helped by, among other things, the following four innovations:

Predictive and prescriptive maintenance can cut down on equipment downtime and over-maintenance

Pharmaceutical facilities sometimes have equipment breakdowns because of stress or long-term wear and tear, like any other business. Traditional or preventive maintenance programs are usually based on a schedule instead of what needs to be done. So, organizations waste time and money on maintenance that isn't needed and doesn't help stop a possible shutdown.

Condition-based maintenance is a step up from calendar-based maintenance. Usually, vibration and temperature monitors determine when equipment is about to break down and needs immediate attention. But this is still a problem for operations because it still requires some reaction. On the other hand, a predictive and prescriptive maintenance approach uses historical data and machine learning to signify when a piece of equipment is likely to break down and find out why. This lets maintenance be planned ahead of time, making it easier to make changes to the maintenance and production schedules. This advanced method avoids risks related to safety and getting the product to the customer.

Making sure deliveries are made on time through supply chain management and helping to reach sustainability goals

Access to life-saving medicines remains one of the most important business needs in the pharmaceutical industry, even though we've seen more disruptions and uncertainty than ever in recent years. Digital tools for planning and scheduling help streamline production and ease supply pressures.

These tools make the production schedule more agile and flexible by using the best tradeoffs between labor, equipment, materials, and energy. The increase in operational intelligence makes it easier for production lines to respond to supply and demand changes and unplanned events in a way that strikes a good balance between short-term and long-term goals. Also, digital planning and scheduling make it easier to be more efficient, which cuts down on waste and CO2 emissions. This helps companies reach their sustainability goals.

Using modern process analytical technology to speed up the production of high-quality drugs

Pharmaceutical production lines often need help with problems like product quality that doesn't meet specifications, long batch cycle times, less-than-ideal product yield, and long wait times for lab testing. Together, these problems make it harder to create medicines that save lives quickly and reliably.

Modernized Process Analytical Technologies (PAT) should be used more often in the pharmaceutical industry. PAT can provide easy-to-understand analytics for finding the right operating conditions for different production scenarios, support closed-loop control for consistent quality and yield, help batch processes become continuous manufacturing, and certify product quality quickly through real-time release testing. With this extra information and speed, pharmaceutical production lines can increase throughput, reduce the number of batches that don't work, and keep the quality of their products more consistent. Together, these things make a big difference in how much things cost to sell and how quickly medicines can get to the market to meet patients' needs.

Ferring Pharmaceuticals is a great example of a company that used PAT and closed-loop control to switch from batch to continuous manufacturing. This gave the company more control over production and a 25 percent reduction in the cost of goods sold.

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