In an era of persistent supply chain disruptions, how can pharmaceutical and biotech companies protect against single-source vulnerabilities without drowning in operational complexity? Six industry leaders recently weighed in on dual sourcing strategies, offering a roadmap for executives seeking resilient supply chains that don’t compromise efficiency.
The consensus is that dual sourcing is essential insurance for late-stage and commercial programs. But success hinges on strategic timing, rigorous standardization, and increasingly, digital orchestration.
Timing: The Make-or-Break Factor
Not all development stages warrant dual sourcing. Dave Miller, Chief Scientific Officer at AustinPx, a contract development and manufacturing organization, emphasizes that premature implementation can backfire.
“In early development, Phase 1 or even most of Phase 2, dual sourcing usually isn’t necessary as you’re working with small volumes, tight timelines, and the goal is simply to establish proof of concept,” Dave explains. “If you try to trigger dual sourcing too early, that’s where you’ll add unnecessary complexity and cost.”
The inflection point comes at late Phase 2 and Phase 3, when pivotal studies and commercialization loom. Dave cites a cautionary example: when HPMC-AS emerged as a key polymer for amorphous solid dispersions, it was initially available from only one supplier in Japan, creating significant vulnerability until a secondary source came online.
For accelerated programs, CDMOs can bridge the gap by leveraging their own redundant sources for raw materials and packaging components, buying sponsors time until formal dual sourcing becomes phase-appropriate.
The Primary-Secondary Model
Jean-Olivier Hirsch, COO of Cellprothera, outlines a practical framework that balances risk reduction with operational efficiency.
“The principle is simple: engage at least two qualified suppliers for the same product with the same specifications,” Jean-Olivier notes. “One acts as the primary supplier, managing most of the volume, while the second covers a smaller but steady share.”
This structure keeps both suppliers production-ready while avoiding the overhead of managing two full-scale partnerships. It also delivers additional benefits, including improved negotiation leverage and more competitive pricing.
However, Jean-Olivier cautions against underestimating the upfront investment. Supplier qualification requires coordinated efforts across purchasing and quality departments—RFPs, audits, contracts, risk assessments, and complaint management. For biotech companies working with biological materials, the challenge intensifies. Finding biosimilar materials with equivalent activity isn’t always straightforward and requires proof of equivalence to prevent production deviations.
Integration Over Duplication
Dr. Stella Vnook, CEO of Likarda, reframes dual sourcing as an integration challenge rather than a duplication exercise.
“At Likarda, we’ve seen how aligning both sources on standardized analytical methods, shared forecasting models, and harmonized release criteria reduces complexity while creating resilience”. She adds that formulation technologies enabling biologics or cell therapies to ship on dry ice rather than ultra-cold nitrogen can further de-risk logistics.
“It’s not just risk mitigation, it’s a smart allocation of resources that safeguards patients and programs alike,” Stella concludes.
A Tiered Approach to Cell and Gene Therapy
Ryan Guest, Senior CMC Translation Consultant at eXmoor Pharma, provides sector-specific guidance for the cell and gene therapy (CGT) space, where dual sourcing spans critical raw materials, manufacturing materials, and final drug product sites.
Ryan recommends several complexity-reducing strategies:
- Harmonize specifications across suppliers with standardized raw material specifications, aligned analytical methods, and unified release criteria
- Strategic supplier selection, potentially choosing CDMOs with multiple sites to consolidate risk management
- Tiered sourcing that focuses dual sourcing efforts on high-risk items like custom reagents, rare cell types, and long lead-time components
“Qualify backup suppliers early in development, ideally during Phase I/II,” Ryan advises, noting that modular tech transfer packages and digital tools like eQMS and MES can streamline documentation and training across sites.
Digital Solutions: The Complexity Antidote
Two contributors emphasize that technology is transforming dual sourcing from a burden into a strategic advantage.
Jonathan Wofford, Chief Commercial Officer at Title21, a quality management software company, argues that standardized digital systems eliminate traditional complexity.
“By standardizing quality records, specifications, and documentation in a shared digital system, sponsors can ensure that data flows smoothly, regardless of supplier,” Jonathan explains. Real-time dashboards and automated audit trails reduce duplicate oversight, helping companies catch problems early.
Alexander Seyf, CEO and co-founder of Autolomous, a data management software platform, goes further: “The perceived complexity of dual sourcing is a byproduct of fragmented, manual data management.”
Digital platforms that provide real-time visibility into batch status across vendors create a centralized control tower to ensure consistent data integrity and automate documentation. “It eliminates the need for redundant systems and manual data entry, allowing you to manage dual sources with the same efficiency as a single vendor,” Alexander notes.
Key Takeaways for Pharma Executives
The expert consensus delivers clear guidance for pharmaceutical decision-makers:
When to implement: Late Phase 2 and Phase 3, when scaling and commercialization risks escalate. Avoid premature dual sourcing in early development unless accelerated timelines demand it.
How to structure: Deploy a primary-secondary model where one supplier handles most volume while a second maintains production readiness with steady but smaller share.
Success factors: Standardize specifications, analytical methods, and release criteria across suppliers. Harmonization is essential to simplification.
Technology enablement: Leverage digital platforms to create unified systems that manage multiple suppliers with single-vendor efficiency.
Resource planning: Budget adequate time and resources for supplier qualification, particularly in biotech where proving equivalence is critical.
As Jean-Olivier summarizes: “Dual sourcing is not about duplication, it’s about smart insurance and business management. Done right, it minimizes risk, strengthens continuity, and creates a leaner, more agile supply chain.”
