OUTSOURCING SUPPLY OPERATIONS


there is now a paradigm shift in the industry’s commitment towards more sustainable processes and greener formulations.


Green chemistry and continuous manufacturing can increase profitability During a panel titled Industry 4.0 – Setting the New Standard for Manufacturing Quality’, experts discussed how eco-friendly practices not only have positive environmental benefits but can also increase an organisation’s profitability. According to Isamir Martinez, Scientific Alliances & Business Engagement Manager at ACS Green Chemistry Institute, applying green chemistry principles can help organisations maximise the efficiency of resources, leading to reduced solvent and reagent use, which in turn will translate into less energy consumption and waste. She also mentioned that artificial intelligence (AI) and machine learning (ML) are tools that can be utilised to create more streamlined and greener processes. Greener and more optimised processes can lead to the production of higher-quality products with less impurities and higher yields, which can increase a company’s profitability, she added. Lawrence De Belder, continuous manufacturing practice lead at Pharmatech Associates, agreed that applying green chemistry solutions on the drug substance side can help excessive resource consumption. However, by implementing continuous manufacturing on the drug production side, organisations are able to produce the same amount of material on a smaller footprint, De Belder added. Specifically, there is less need for intermediate storage units/facilities with continuous manufacturing, leading to less overall electricity usage as all processes are connected to each other, as well as less water consumption for cleaning purposes. Additionally, continuous manufacturing


reduces excess material production, which would need to be incinerated, and thus it offers “a big improvement to the environment” in terms of carbon footprint. De Belder thinks that in the future, each country’s government will impose improvement numbers to reduce carbon dioxide (CO2) emissions from companies over time. Therefore, “companies will need to find solutions for this, and


A staggering 40.7% of facilities resort to incineration of medical waste, despite only 18.5% of respondents seeing this as an ideal practice


continuous manufacturing will be one of the potential ways to do it”, he stated. Krishna Venkatesh, global head of Injectables Operations at Dr Reddy’s Laboratories, highlighted that digitisation is necessary for continuous manufacturing in the future. Venkatesh emphasised that Dr Reddy’s Laboratories is preparing to enter a “zero touch” era where the goal is to reduce variability in the manufacturing process by minimising human involvement and enhancing digital capabilities. The approach involves digitising operational systems (utilising electronic batch records), deploying sensors and data acquisition systems, and utilising AI engines for data analytics to create “a correlation between quality attributes and process parameters”. The emphasis is on transforming data into actionable insights to improve processes and facilitate more intelligent decision-making in manufacturing, which will “enable continuous manufacturing in a very powerful manner”, he added. Danita Broyles, associate director, Quality


Assurance-Analytical Compliance, Harmony Biosciences, San Gabriel, California, US agreed that transition from paper-based to digitised systems is crucial and emphasised its ability to seamlessly connect data across manufacturing steps. This interconnected digital approach enables efficient problem-solving, allowing for the identification of issues such as compression problems and discerning whether they stem from equipment or ingredients, she added. The focus is on utilising digital systems to streamline processes and enhance efficiency, even in smaller pharmaceutical companies


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