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Opposites Attract – Blurring the lines between small and large molecule manufacturing

The biopharmaceutical industry has grown impressively in last years with its global compound growth rate (CAGR) estimated to reach 8,5% between 2018-2023, surpassing traditional new chemical entity sectors. Emerging novel drugs show huge therapeutic potential like antibody-drug conjugates, checkpoint inhibitors and viral gene therapy. As the industry grows, it may face potential issues securing an expanded supply chain.

 

Until recently the bio industry’s primary focus was to simply get their products to clinic as quickly as possible and with little incentive to focus on product and supply chain efficiency. However, now that the industry is experiencing greater demand and product volumes are increasing combined with generics and healthcare reforms there is an increased desire to explore how overall cost of production can be lowered. It’s a mirror image of the small molecule industries maturation some 10 or 20 years earlier. As a result, innovators and bio-generic companies are exploring not only how to speed products to market but also how they could lower costs in the commercial phase.

 

Large biopharma companies have now a greater number of drugs in the pipeline and with an increased global demand of biosimilars the supply chain will come under increasing pressure. In fact, the industry is still in its relative infancy and some of the key factors that may allow companies to meet these demands are not yet fully matured.

 

In addition, as biologics developers are more comfortable using outsourcing providers, there is a gradual shift away from performing all production activities in-house. Many contract development and manufacturing organizations (CDMOs) developing and investing in the skills and technologies required to make biological drugs.

 

Another aspect which may increase the amount of work in biologics is the growing complexity of biological products. Biotech firms, especially smaller ones, may have an innovative product or idea but lack the expertise and technology required to develop or commercialize it.

 

The product classes themselves are also becoming intertwined as many advanced therapies now contain a small molecules payload. In addition, small molecules themselves are growing increasingly large and peptides are now routinely synthesized rather than fermented. As a result, the level of limited collaborations across both small and large molecules in past years increased. Many in the industry believe there are transferrable skills that can be shared between the two particularly in areas like processing and scale-up, staff and regulation.

 

Active Pharmaceutical Ingredients (APIs) manufacturers having the most relevant skill sets as their experiences are most similar to what a biopharma company is replicating in everyday use. For example, API synthesis is performed in solution, with materials, molecules and reactants emerging over time. The instruments used for chemical and physical measurements for a-pi production may only need minor alterations to be useful in fermentations.

 

Beyond APIs there are potential benefits in exploring overall manufacturing methodologies. Whilst large molecules companies have just recently begun to generate their own optimization data, the small molecule industry has been about for 50 years streamlining its supply chain to establish the best practices. Most prominent areas where large molecule could learn from small molecule firms might be process control, quality management and training operators beside process development, clean room operations, regulatory compliance and automation/process control.

 

Biopharma as an industry is more experienced in adopting new methods like single use technologies which reduce the need for scale-up as well as complicated weighing and dispense steps and cleasning validation.

 

If these two industries could learn from each other’s strengths they will have the capability to manage and even streamline the complex supply chains and development timelines in order to meet greater demand and reduce the overall costs.

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