Pharma Manufacturing Pain Points: How a clear strategy could be the vaccine your company needs

Batch Size

Like any manufacturer, pharma companies are under growing pressure to match supply and demand, sometimes with the added complexity of handling live organisms. Not only that, but every batch could comprise thousands, if not millions of units of manufactured product.

Working with active ingredients means pharma companies cannot afford delays in production that result in scrapped batches. With the tools to accurately forecast demand, identify bottlenecks and evaluate capacity, they are well-placed to deliver on-time, in-full (OTIF).

But how can you achieve this?

The answer lies in having a robust data-driven planning and scheduling strategy in place, supported by an Advanced Planning and Scheduling (APS) system. This gives production managers a single view of the production process, tasks and their dependencies so they can make informed decisions about what to order and when.

The threat of cyber attacks

Cybersecurity has been a growing concern for virtually every sector in recent years with cyber-attacks regularly making headlines as the world becomes more connected.

With reports that the pharmaceutical industry is a prime target for cyber criminals, costing the sector billions of dollars in damages, it’s never been more pertinent for pharma firms to put measures in place to protect their businesses.

You need only to look at the Merck & Co cyber-attack to see the damage these events cause. In 2017, Merck & Co was hit by a ransomware attack leading to extensive worldwide operational disruption and costing insurers $275 million.

With pharma organizations taking an average of 206 days to discover suspicious activity, prevention is better than cure.

Ensuring you have a robust and detailed cyber-attack plan in place and that members of the team have been briefed on how to action it in the event of a breach is paramount.

Mitigating security risks should not fall solely to the IT department. Rather, it’s down to all employees and stakeholders to adhere to best cyber security practice at all times.

Adopting a cloud-based scheduling solution can ensure you have enterprise-grade security. Your database can be continually monitored, protected, optimized and backed up.

Fail to have a cyber security strategy in place, and your company risks intellectual property theft, including the results of clinical trials. Then, of course, there are litigation suits, supply chain disruptions and, ultimately, lost profits.

Drug pricing

The cost of drug prices in the US has been widely debated in recent years. Indeed, according to a GlobalData report, more than half of global pharma organizations believe drug pricing will have the biggest impact on the pharma industry in the future.

As politicians and regulators come under pressure to freeze prices, pharma manufacturers across the US and beyond will need to keep production costs down.

The US government is currently aiming to reduce Medicare spending by 30%, so pharma companies need a strategy that will allow them to work as efficiently and productively as possible. Investing in a robust APS system helps you to plan more effectively, and strategically align stock production levels to supply and demand.

Sterilization challenges

Sterilization is, of course, an essential part of the pharma manufacturing process, although every company has its own challenges. In bio-pharma, for example, manufacturers depend on full automation of clean-in-place (CIP) systems and the residual proteins left on equipment walls after they have been cleaned by CIP.

CIP helps to maintain a sterile environment for manufacturing, as well as supporting adherence to cleaning validation operations, in line with industry standards.

Cleaning validation maintenance checks are performed at least once a year. By taking a risk-based approach to identify any potential future failures, your business will be in the best position to quickly resolve them. The advantage of some (APS) systems is that they provide an audit showing when each batch has been sterilized. With a clear view of calibrations and CIPs on its scheduling board, users can immediately see when sterilization has taken place and its duration, reducing the chance of error.

The strength of the US pharma sector means it is already in a good position to stave off challenges and make the most of new opportunities, as long as it has the right production processes in place.

To find out more about how Access Group could support your pharmaceutical business, or to arrange a demo of Access Orchestrate, click here.