Supply chain interruptions can be costly for pharmaceutical firms—and for their patients, life-threatening. That is why players along the pharma pipeline are looking at solutions that could help safeguard their operations from any such snags.
Jason Zhang, associated director/head of R&D for Lonza’s Small Molecule API Division, connected with Outsourcing-Pharma to discuss how companies can tackle such challenges proactively.
OSP: Could you please share an overview of key challenges (including new and emerging ones) facing the pharma supply chain before COVID?
JZ: Small emerging and virtual biotech companies have a record of starting their small-molecule clinical pipeline in the early stages with several candidate compounds in their hands. Before the pandemic, key complexities in early phase projects include finding a qualified supplier for new and custom-made starting materials as well as maintaining its robust quality while staying ahead of the development pipeline to deliver these materials.
These complexities are mainly due to:
Need for speed
There’s a record of FDA approvals with an expedited regulatory pathway – orphan, fast-track, break-through. Lonza’s recent investments in its Nansha facilities allow us to be physically closer to high-quality and reliable raw material suppliers in Asia, allowing for quicker problem-solving. When there is difficulty in finding external suppliers, Lonza’s Nansha facilities can easily step in with the preparation of raw materials to expedite the process and stay within the timeline.
Need for bioavailability enhancement
As the majority of candidate compounds have solubility issues, they need to go through several enabling technologies to ensure they are as effective and efficient as possible.
Lonza adapted its offerings to support our customers earlier in the product life cycle, with a pool of experts and subject matter experts to act as consultants to the customer. Their expertise spans different topics such as process and analytical development of drug substance and drug product, bioavailability, quality assurance (QA), risk assessments (RA), and regulatory support.
OSP: How has COVID exacerbated these issues and created new ones since it arrived?
JZ: This pandemic represents a global challenge, but the situation has also pushed us to improve the way we manage our supply chain. We have seen the advantages of having a global network of sites that allows us to buffer supply and demand to a certain degree. We worked to rapidly build and expand our manufacturing capabilities and supply chains to further support our customers.
The overseas transportation of select bulky chemicals is impacted by fluctuations in travel and shipment regulations. This problem can be solved by having supply networks both locally and regionally.
With our recent expansion of Lonza’s highly potent APIs/API capabilities in Nansha, our global and Western partners will have a more secure supply chain for their small-molecule HPAPIs due to an integrated strategy from early phase to commercialization, decreasing external supply stakeholders and potential challenges.
OSP: How have CDMOs worked to maintain a resilient, robust supply chain? Please feel free to talk about solutions that have worked, ones less successful, and gaps that persist.
JZ: At Lonza, we work with our customers to build resilient supply chains that can withstand external pressures, including slowdowns caused by disease outbreaks, natural disasters, and other events outside human control. Our efforts provide significant supply chain simplification and other logistical benefits to our customers.
Among other ways of maintaining a resilient supply chain, CDMOs need to work closely with their supplier and if needed even provide support for issue resolution. At Lonza, we have established a robust network of suppliers we work with allowing us to move quickly and to react rapidly to unforeseen supply challenges.
OSP: You suggest an integrated, global strategy can help minimize risk in supply chains—could you please elaborate?
JZ: Lonza’s global network has multiple sites across three regions: the Americas, Europe, and Asia. This allows us to guarantee backup solutions and secure supply chains. Our fully integrated offering enables a simplified supply chain with shorter and accelerated timelines, spanning from drug substance to drug product development and manufacturing, including particle engineering, solid-state services, as well as bioavailability enhancement.
With an integrated global strategy, there is a lower risk of supply chain disruptions as services from early-stage to manufacturing will be handled by one reliable contract manufacturer. This protects customers from crises like the COVID-19 pandemic as there are fewer points of disruption, which allows them to stay within their development timelines and efficiently move their drug products to the market.
OSP: Why are biotechs looking at China to develop their drug products? What factors in the market and regulatory bodies contribute to this?
JZ: In China, the ecosystem for the biopharma industry has developed rapidly and is very favorable to biotech growth. There are several reasons why pharma companies are looking at China, such as:
- Large patient pools allow for fast signup of clinical trials
- China joined the International Council for Harmonisation in June 2017, allowing recognition of clinical data from China and overseas
- Biopharma is a national strategic industry supported by the Chinese state and local government
- There are rapid regulatory reforms for new drug approvals and access for both Chinese and foreign companies
- Talent from around the world is relocating to China and strengthening its capabilities from discovery to manufacturing
- China has a comprehensive and stable supplier network
OSP: How can supply chain strategists effectively and efficiently pivot to China?
JZ: Supply chain strategists must respond efficiently and appropriately to industry trends. These include:
- The continued high growth of the Chinese market
- China’s basic national policy in moving forward with Reform and Open and international trading
- COVID-19’s effect on the global supply chain
- China’s fast-growing industries, such as biopharma that will demand high volume, low cost, and short delivery times
- The government and downstream producers’ emphasis on localization of production and supply chains could lead to higher demand for local and in-country warehouse and distribution centers
- Many firms are accepting more inventory than before.
OSP: Please tell us about Lonza’s reach into China, including investment in the Nansha facility.
JZ: Lonza’s Nansha site was built from scratch in 2003 in Guangzhou to expand our small molecule active pharmaceutical ingredients (API) offering in a fast-growing market. After almost 20 years, the Nansha site remains very strategic for our API offering as it guarantees high flexibility, accelerated timelines, and access to highly experienced scientists.
With around 650 employees, Lonza Nansha is a critical component of the global Lonza network that offers high-quality, scalable manufacturing services at all stages of the API development cycle.
Our investments in the Nansha site demonstrate its important role in our network. We recently invested CHF 20 million in the site’s HPAPI/API facilities to meet market trends and allow increased flexibility and shortened timelines for drug substance process and analytical development.
This investment also optimized assets for early phase programs to include three new 1000L equipment trains and increase Lonza’s capacity for clinical manufacturing and small volume commercial products, further enabling support for emerging biotech companies in the region.
The expanded capacity for our Nansha facilities will allow for mid-scale manufacturing to ensure a smooth transition between early-phase and commercialization, displaying Lonza’s integrated global strategy and providing our global Western partners with a reliable supply network from day one.
OSP: Is there anything else you’d like to add?
JZ: The Nansha site is fully integrated within Lonza’s Small Molecules network. It enables our customers with the possibility to access different technologies within the entire drug life cycle with a simplified supply chain that guarantees accelerated timing, reduced risks, and improved communication.
