Q&A: The growing importance of supply chain security within API manufacturing

Executive Summary

  • Drug development is becoming more complex, creating an incentive to partner with specialist companies that can deliver solutions to industry challenges – including supply chain issues, poor solubility among new drug candidates, and the need to reduce carbon footprint.
  • Leading technologies such as the CESS® nanoparticle engineering can both overcome drug development challenges and help to simplify supply chains, securing life-changing therapeutics for patients.
  • To meet current and future demand for game-changing API and HPAPI therapeutics, it is important to partner with a company that can handle the right product at the right scale.


What are the challenges faced by the pharma industry?
Pharma professionals are grappling with the fact that drug development is becoming more complicated. There are more modalities, more ingredients – and, of those, more difficult-to-handle ingredients. There are also more globally dispersed customers in a world that is battling the emissions contributing to climate change.

In small-molecule drug development, new drug candidates are presenting with increasingly complicated chemical structures that are poorly water soluble, leading to poor bioavailability – a major cause of drug development failure. There is also growing demand for more patient-friendly therapeutics, such as more targeted, high-potency APIs in oncology, or dosage forms that are more convenient for patients – for instance, smaller pill sizes.

In light of the changing market landscape, there is a greater incentive to partner with specialists who can help overcome specific challenges and enable therapeutics to progress into clinical development. Companies are stepping up to deliver technological innovations that can help both the pharma industry and patients in this more complex world. At the same time, solutions that facilitate a simpler and more reliable supply chain are in high demand, partly due to uncertainty created by geopolitical turbulence such as the Russo-Ukrainian War.

Another consideration is that for products in clinical development, any issues or risks in the supply chain could dramatically affect whether the company is successful or not. Having a secure supply chain is imperative for early development companies, as well as ensuring processes are easily translatable when the asset gets acquired by major pharma further down the line.

The question becomes, how do you provide much-needed innovations while protecting the integrity of the supply chain? To understand this, it is first necessary to examine how the supply chain has changed in recent years.

How has the supply chain changed?
Most large pharma companies took the decision to outsource most manufacturing to cheaper countries and external organizations. As a result, much of the current supply chain is rooted in the East. Indeed, as of 2021, China is the world’s main supplier of raw materials including key starting materials, intermediates, and APIs. The geopolitical stress placed on countries like China has highlighted the need to move manufacturing closer to home to de-risk supply chains for pharmaceutical products, particularly those that are critically needed by patients. Coupled with this are environmental concerns associated with shipping over long distances, which are an important driver for many large pharma companies and one that influences partner selection and decision-making in the supply chain.

Having technologies available that can not only improve the product from a patient perspective, but can also reduce potentially the dosage required for products, could have a massive impact on the whole supply chain. It might also support some of the nearshoring and onshoring activities that major pharma are currently exploring by enabling a lower manufacturing footprint and allowing manufacturing to be more easily shifted to Western-based environments.

How is Nanoform working to support the pharma industry?
A collaborative approach is key to unlocking tailored solutions that address formulation challenges and can simultaneously be delivered reliably to support the supply chain. Nanoform’s process, informed by decades of experience in Big Pharma, involves taking bulk powder APIs that are struggling with poor solubility, and converting them into nanoparticles with our one-step Controlled Expansion of Supercritical Solutions (CESS®) technology. We can then take these solubility-enhanced API nanoparticles onward into the formulation stage, where our expert formulation team collaborates with clients to optimize performance according to agreed specifications.

CESS® could have the positive effect of simplifying the supply chain, as nanoparticle uptake in the body provides an opportunity for significant dosage reduction, leading to smaller pills or the ability to convert a multi-tablet dosage into a single pill. This, in turn, can help to reduce transportation and logistics-based emissions and complications, with less packaging and fewer tablets needing to be shipped. Our CESS® process has also been designed to work without necessitating additional excipients, meaning fewer ingredients need to be sourced.

Additionally, by reducing the quantity of API needed per unit of drug product, an API manufacturing campaign could be significantly shortened. This could provide huge cost saving opportunities to clients – for example in storage, sampling, and release activities of the API.

How can pharma companies prepare for the future?
In order to be prepared for the future, it is essential to partner with a company that can handle the right product at the right scale. Attracting staff with expertise from large pharma companies helps to ensure robust, scalable processes that can deliver drug products on time and in full – something we took care to incorporate at Nanoform.

Investing in facilities is equally important, especially when it comes to preventing bottleneck situations before they arise. For example, at Nanoform we have recently expanded our GMP manufacturing facilities. Our two additional manufacturing suites, together with GMP analytical characterization laboratories, possess the globally unique capability of handling highly potent compounds to less than 30 ng/m3 (SafeBridge Cat 3B). This was driven by the clear market gap, with increasing demand for HPAPIs and a shortage of facilities capable of handling them safely. 

Regardless of the specific challenges faced, a reliable supply at the scale needed to meet demand is crucial.

Would you like to learn more about how Nanoform can improve the performance of your drug molecules and simplify the supply chain? Email info@nanoform.com for more information.