3 lessons from COVID-19 about reconciling sterility with efficiency

6-Apr-2022

The challenges pharmaceutical companies have faced in the race to develop a COVID vaccine and the key lessons they can bring into 2022 and beyond. Written by Christian Dunne

The drive to manufacture and commercialise vaccines to tackle COVID-19 took place at an impressive speed and on a scale never before seen in the pharmaceutical industry. Millions of doses have now been delivered to patients around the world, and millions more continue to be manufactured.

Growth of overall vaccine spending has been higher than any other year on record, and total cumulative spending for the COVID-19 vaccine is projected to reach $157 bn by 2025.

This past year has shown that it is possible for the pharmaceutical development and manufacturing process to achieve new levels of speed and efficiency, all while maintaining optimum levels of sterility required for vaccine production.

However, the successful rollout of the vaccine at such speed does pose a challenge for pharma companies developing new vaccines and biopharma treatments in the future. The general public, investors and other key stakeholders now have heightened expectations about what the industry can achieve and how quickly they can deliver. As such, there is pressure on pharma companies to match their COVID-19 success on new projects.

Companies must reflect on what they got right and what went wrong

With this in mind, companies must reflect on what they got right and what went wrong during the vaccine drive over the past year to ensure they are well prepared for future wide-scale drug developments.

Reconciling sterility with speed and efficiency

When it comes to the fill and finish of vaccines, there are many sterility considerations that manufacturers must adhere to.

As parenteral drugs, vaccines are injected directly into the body, meaning they bypass many of the body’s defence systems in the gastrointestinal and nasal tracts. As a result, the formulation and processing of vaccines and biopharma treatments must take place in a carefully controlled and sterile environment to optimise particulate and bioburden control and maximise patient safety.

But ensuring sterilisation across vaccine production lines can be challenging, as it’s crucial that the ingredients within the vaccine itself remain uncompromised.

Although many small-molecule pharmaceuticals are terminally sterilised within their barrier systems, this isn’t possible for vaccines as the process can damage, degrade, or inactivate the final product.

Instead, vaccines must be developed using aseptic processes in a contained cleanroom environment to ensure that a sterile boundary is maintained around the vaccine and its packaging across the entire production process.

The equipment required to achieve this sterility is highly specialised and requires thorough decontamination between every use.

Before and after every process, the equipment must be cleaned and sterilised to ensure that no contamination takes place and quality control is maintained all while meeting regulations. This is a process that can often be time-consuming and costly as specialised equipment, cleaning materials, and the expertise of trained personnel is required.

3 Key Learnings for the future

The COVID-19 pandemic demonstrated that it is possible for pharmaceutical companies to ensure sterility while streamlining vaccine production processes.

So, what can we learn from the vaccine roll-out to ensure we can achieve a similar balance of speed and efficiency while ensuring they maintain a sterile processing environment in the future? Here are 3 key learnings of the past year that vaccine producers must take into 2022 and beyond:

One: Strengthening supply of production line equipment

At the height of the pandemic, many pharmaceutical companies were hit by supply chain disruptions which stifled the supply of key aseptic production line components, such as SUTs. Even before the pandemic, adoption of these components across pharmaceutical manufacturing lines had already skyrocketed, and heightened demand during the outbreak threatened widespread shortages.

The US and India incentivised national pharma companies to onshore supply chains

To better combat these risks and ensure the sterility of life-saving vaccines, many companies needed to reconsider their supply chain for production line equipment.

Some manufacturers took a localised approach during the pandemic, with countries such as the US and India incentivising national pharmaceutical companies to onshore their supply chains to minimise the risk of disruption from overseas shipping.

Others took steps to hold an intermediary stock of SUTs and other production line components to ensure continuity of production in the event of future disruption. Many suppliers of production line components have been working closely with pharmaceutical companies to enhance stockpiles of components. This collaboration ensures that pharmaceutical companies are equipped to maintain continuity of production lines without worrying about supply chain disruptions.

The washdown procedures necessary for aseptic production are not the only processes that can lead to significant operational downtime

Adopting new supply chain approaches such as these as we move into a post-COVID world can help pharmaceutical companies ensure a more resilient supply chain in future to maintain continued high levels of speed and efficiency while maintaining sterility.

Two: Streamlining maintenance requirements

The washdown procedures necessary for aseptic production are not the only processes that can lead to significant operational downtime. Maintenance can also reduce productivity. The last 18 months have highlighted the need to identify solutions to streamline maintenance requirements while ensuring optimum line performance.

Hailed as part of ‘Industry 4.0’, smart factory technology has huge potential to achieve this goal, streamlining maintenance procedures to enhance efficiency across drug manufacturing lines in the future.

This technology incorporates smart monitoring solutions into drug production lines to provide manufacturers with real-time data on the equipment being used.

Having access to these insights can be hugely beneficial for pharma companies as they will be able to access at-a-glance information on the health status of their equipment which can help reduce downtime and prevent mid-batch equipment shutdown that can potentially impact sterility. One such example of how this technology can reduce downtime across manufacturing is through predictive maintenance capabilities. Predictive maintenance technology analyses data from normal manufacturing periods and predicts when maintenance is likely to be required again.

In turn, this helps manufacturers lengthen the lifespan of their manufacturing equipment, helping them to mitigate against unplanned downtime and reduce operational costs. Having a predictive maintenance strategy in place can help manufacturers reduce asset downtime by 30-50% and increase asset lifespan by 20-40%.

The insights provided via smart technology can be accessed remotely via an online dashboard or mobile device, enabling manufacturers to monitor the status of components in real time even across facilities.

Having access to this information in an instant means that line operatives can see where maintenance might be needed across their equipment long before productivity or sterility is affected.

By putting such a preventative plan in place ahead of time, operatives can quickly resolve any issues and minimise downtime associated with removing compromised products and washing down affected equipment.

Three: Adopting single-use technologies

The development of the COVID-19 vaccine highlighted that one of the most effective ways to ensure sterility across aseptic processing is to adopt Single-Use Technology (SUT).

Globally, the single-use bioprocessing market size reached $15.8 billion in 2020 and is expected to expand at a compound annual growth rate of 16.0% from 2021 to 2028. SUT is bioprocessing equipment that is designed to be used once and then disposed of, with components most often consisting of bags, tubing systems, filters and connectors.

By ensuring the aseptic integrity of products during transit as well as within manufacturing facilities, SUT helps to significantly reduce the time and costs associated with packaging and decontaminating reusable containers by serving as the product’s primary packaging material for transportation across facilities.

Many vaccine producers have adopted SUTs in their sterility processes as they require minimal training and expertise to install, allowing them to reduce operational downtime by streamlining washdown procedures and boost efficiency across production lines.

One SUT component that helps streamline the drug transfer process by optimising manufacturing capacity is the split butterfly valve (SBV).

SBVs are comprised of two components, an ‘active’ half which connects to production line equipment and a ‘passive’ half which attaches to the filling container, bag or primary packaging.

Once they are connected, these components create a single sealed unit, allowing the product to flow from the container into the process line, maintaining a closed processing environment for aseptic integrity. After use, instead of needing to be cleaned, the passive half and container components are disposed of, simplifying washdown processes, whilst the multi-use Active half remains in place for CIP/SIP or decontamination steps alongside the process equipment.

By incorporating SUTs into their manufacturing processes, pharmaceutical manufacturers will be better equipped to confidently maintain sterility across production lines in future, while reducing downtime and enhancing efficiencies.

Looking to the future

While the COVID-19 pandemic highlighted various vulnerabilities, the speed and flexibility of the vaccine rollout also demonstrated many strengths in the pharmaceutical industry.

Aseptic processing can be a challenging and time-consuming necessity for drug production. But the past 18 months have demonstrated that there are effective ways to optimise and streamline these processes to ensure aseptic processing, making pharmaceutical companies better equipped to accelerate vaccine development in the future.

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