How can pharma achieve ‘Net Zero’? Through driving change in pharma manufacturing

Through the entire product lifecycle – production, consumption and disposal – the pharma industry significantly impacts the environment.  

There is much to be gained through reducing pharma’s ‘Environmental Factor’, as Girish Malhotra, President of EPCOT International, discussed in his recent blog post. Aside from the clear benefits to the environment, taking strides towards more sustainable practices will lower production costs, limit the burden of healthcare costs on authorities and protect public health. 

So, where should pharma start?  

According to Malhotra, API manufacturing and formulation companies have the greatest chance of meeting their climate goals by overhauling their manufacturing processes, though this presents its own set of challenges.   

He suggests focusing on three core aspects: solvent reduction, yield improvement and efficient asset utilisation. 

Three core pillars of green manufacturing 

Solvent reduction 

Pharmaceutical manufacturing is the most solvent-intensive of all chemical processes, and its reliance on solvents is commonly recognised as an environmental concern. These concerns generally relate to three areas: the source and synthesis of the solvent itself; its properties in use, including accidental discharge; and disposal.  

By altering API manufacturing processes so that solvents are reduced and more waste solvents are recovered, companies stand a greater chance of reducing emissions and limiting ecological damage linked to discharge and disposal.  

Yield improvement  

When a process is improved to increase yield, waste is reduced and less solvents are required. Ultimately, yield improvement means the process is more efficient and fewer resources are required to achieve the end result - good news in terms of emissions.  

Efficient asset utilisation  

Efficient utilisation of assets not only reduces emissions from API manufacturing but lowers costs and ultimately makes the process more economically viable. Asset utilisation is closely linked with yield improvement and solvent reduction.  

For example, making a process improvement that results in higher yield will not only reduce the number of solvents used, but also improve asset utilisation and batch cycle times. Whereas failing to iterate on existing methods will promote inefficiencies and poor asset utilisation. 

Reaching ‘Net Zero’ - challenges to sustainable manufacturing 

So how can API manufacturing and formulation companies reduce solvent use, improve yield and utilise their assets efficiently? According to Malhotra, sustainability needs to be considered at the onset of process development.  

If pharmaceutical companies do not consider solvent reduction and yield improvement at the onset, it is extremely difficult for API manufacturers to do anything down the line.  

For existing products, the biggest challenge to sustainability-focused process change lies in regulatory compliance. Overhauling the manufacturing process would require companies to seek regulatory reapproval for impacted products, which can be time-consuming and expensive. This presents a significant barrier to wide-spread, impactful change within the industry.  

In a 2019 study looking at pharma emissions, the authors noted that process improvements are not an industry norm. They said the pharma industry has traditionally been ‘so profitable that it can afford to be extremely wasteful in its manufacturing processes’ and has ‘little economic incentive to optimise those high-footprint processes’.  

Malhotra agrees. He says ‘nothing will change’ until API manufacturing and formulation processes are overhauled, but notes that issues like regulatory requirements, drug performance and cost are major blockers.   

While pharma has been incentivised to take some strides towards ‘Net Zero’, it can be argued that the infrastructure (legal and financial) is not yet in place to propel industry-wide change in drug manufacturing.