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The rise of nucleic acid therapeutics (NATs) — including oligonucleotides such as siRNA, mRNA-based products, and CRISPR-based drugs — is transforming modern medicine. These precise and potent modalities are advancing rapidly through development, posing new challenges for achieving scalable and compliant manufacturing.

 

Early-stage NAT developers often rely on multiple specialized vendors across different production stages. While this fragmented supply chain model may offer access to niche expertise or perceived cost advantages, it can also introduce inefficiencies that can lead to project delays and regulatory complexity, ultimately adding cost and slowing progress to the clinic.

 

This blog post explores the operational and strategic drawbacks of a fragmented supply chain and outlines how partnering with a single, vertically integrated CDMO can streamline development, reduce risk, and accelerate timelines.

Challenges and hidden costs of fragmented supply chains

The flexibility of a fragmented supply chain may seem advantageous, but it often introduces significant challenges, including:

Operational complexity

Coordinating multiple suppliers requires extensive oversight. Internal teams are required to manage the complicated moving parts of the supply chain and address cross-supplier issues, diverting resources from core functions and increasing administrative overhead.

 

 

Diminished traceability and regulatory risk

Disparate quality systems and inconsistent documentation can complicate and delay root cause investigations and regulatory submissions, compromising traceability and increasing the risk of non-compliance during audits.

 

 

Delayed program timelines

Each material handoff between vendors adds variability and potential delay. Discrepancies between analytical methods and documentation standards may necessitate re-testing, rework, or lead to material loss. Additionally, physical shipments are vulnerable to damage or loss, causing delays that ripple across development timelines, with implications for funding, time to market entry, and revenue.

Cumulative cost impact

Individual vendor pricing can appear competitive and attractive; however, hidden inefficiencies that are revealed as programs unfold can greatly inflate the true cost of development. 

 

 

Advantages of vertical integration

Vertical integration consolidates all stages of production, from raw materials to the final drug manufacturing, within a single organization, ensuring streamlined operations, consistent quality, and end-to-end oversight. The challenges and hidden costs associated with a fragmented supply chain model can be effectively mitigated. The advantages include:

 

• Accelerated timelines by eliminating handoffs and reducing issue resolution delays.
• Consistent quality through harmonized systems and processes.
• Simplified program management with a single accountable partner.
• Improved regulatory readiness via unified documentation and traceable workflows.
• Strategic program prioritization supported by dedicated resources and aligned objectives

 

Beyond operational efficiency, vertical integration delivers strategic control. Programs receive dedicated attention, fostering deep collaboration instead of fragmented vendor interactions.

 

Drug developers can benefit by considering a strategic shift from short-term cost-cutting to long-term value creation. Selecting a capable, vertically integrated CDMO partner provides end-to-end control, enabling faster and more reliable therapeutic development.

 

For a more in-depth look at how vertical integration can truly transform your NAT manufacturing strategy and to understand the specific solutions, download our recent whitepaper.

 

Contact our expert team to make a strategic investment in predictable, high-quality and rapid development, helping you bring your life-changing therapeutic to patients faster.