Suppliers and packagers for ONPATTRO

ONPATTRO

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922	NDA	Alnylam Pharmaceuticals, Inc.	71336-1000-1	1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) / 5 mL in 1 VIAL, SINGLE-DOSE	2018-08-13

ONPATTRO (patisiran) supplier landscape: key manufacturers, fill-finish, and raw-material sourcing critical for R&D and supply risk

Last updated: June 14, 2026

ONPATTRO (patisiran) is a lipid nanoparticle (LNP) RNAi therapeutic. The supplier universe is dominated by (1) upstream LNP/lipid and cGMP biologic drug substance manufacturing, (2) sterile fill-finish and final drug product operations, and (3) regulated secondary suppliers for oligonucleotide raw materials, lipid excipients, and container-closure systems.

No complete, query-ready supplier list by name and site can be produced from the information provided.

What are the main supplier categories for ONPATTRO (patisiran)?

ONPATTRO’s supply chain typically separates into these procurement buckets:

Drug substance (patisiran) and LNP manufacturing supply inputs

• Oligonucleotide components (patisiran is an siRNA; sourcing includes nucleoside phosphoramidites, linkers, and other controlled RNA synthesis reagents)
• Lipid nanoparticle components
  • Ionizable lipid
  • Helper lipid(s) (commonly phospholipid-like components)
  • Cholesterol or related lipid excipient systems
  • PEG-lipid components for particle stabilization
• Manufacturing consumables
  • Solvents and buffers used for RNA and LNP formulation steps
  • Filtration and single-use processing hardware that meet cGMP requirements

Drug product supply inputs

• Sterile vial fill-finish systems
  • Aseptic filling equipment
  • Cold-chain compatible packaging and labeling materials
• Container-closure system suppliers
  • Sterile vials, stoppers, seals, and overwraps that meet particulates and extractables requirements
• Quality release testing providers
  • Analytical services for identity, potency, purity, encapsulation, particle size/distribution, oligonucleotide integrity, and lipid impurity profiling

Logistics and cold-chain service providers

• Temperature-controlled distribution for a chilled biologic-like supply chain

Which companies supply the lipid nanoparticle components used in ONPATTRO?

ONPATTRO’s LNP is a proprietary formulation system; direct supplier naming requires Orange Book/Biologics license application manufacturing disclosure, inspection records, or NDA/BLA CMC supplier-to-site mapping. Those source-level disclosures are not provided here, so a complete supplier list cannot be generated.

What manufacturers do the ONPATTRO drug substance and drug product production sites use?

Site-level manufacturer identification for ONPATTRO (drug substance vs drug product, and any contract development and manufacturing organizations) requires specific public disclosures such as:

• FDA BLA manufacturing site listings,
• published CMC sections tied to ONPATTRO’s regulatory filings,
• inspection assignment pages and establishment identifiers,
• contract manufacturing announcements.

Those disclosures are not included in the information provided.

How do ONPATTRO suppliers differ by function: LNP, sterile fill-finish, analytics, and packaging?

Even without naming sites, ONPATTRO procurement structure in practice follows function:

LNP component sourcing

• Specialized chemical supply chain for lipid excipients and controlled ionizable lipid intermediates
• Tight change-control requirements for impurities and grade specifications

Oligonucleotide raw-material sourcing

• RNA synthesis reagent suppliers are qualified under nucleic-acid-specific impurity specifications and residual solvent/residual reagent limits
• Lot traceability is critical for potency and integrity attributes

Sterile drug product fill-finish

• Aseptic fill-finish is typically the gating operation for batch release timelines
• Leachables/extractables and container-closure compatibility drives supplier qualification cycles

Release analytics

• Potency and identity testing can be outsourced to specialized analytical service providers in some portfolios, but ONPATTRO release testing often stays within the sponsor’s qualified labs

Are there alternative suppliers for ONPATTRO raw materials to mitigate shortages?

A shortage-mitigation posture usually centers on:

• dual sourcing of lipid excipients and key solvents,
• qualification of alternate container-closure systems,
• manufacturing tech transfer and comparability packages for site substitutions.

A supplier-specific mitigation map cannot be produced without site-level and supplier-level disclosure.

What supplier risks affect ONPATTRO availability and batch release?

Key risk drivers for LNP RNAi products are:

• variability risk in lipid excipient grades and impurity profiles
• aseptic fill-finish capacity constraints
• cold-chain logistics failures
• analytical method transfer constraints for potency and encapsulation attributes
• container-closure component supply interruptions

How does supplier qualification work for ONPATTRO (patisiran) under cGMP?

Supplier qualification for ONPATTRO is governed by:

• incoming material specifications and stability requirements
• change control for lipid grades and key intermediates
• qualification of alternate manufacturing sites for DS/DP components
• regulatory-compliant bridging data for CMC changes impacting quality attributes

What patents or IP constraints can affect ONPATTRO suppliers for manufacturing?

ONPATTRO’s core IP covers:

• RNA sequence and formulation approach,
• LNP composition and manufacturing methods,
• specific process parameters that influence particle size, encapsulation, and stability.

Supplier substitutions must manage both regulatory CMC comparability and process IP constraints. However, supplier-level IP barriers are not enumerated here because patent mapping requires the specific ONPATTRO patent estate and claim-to-process linkage, which is not provided.

How strong is ONPATTRO’s supplier dependence for LNP and sterile manufacturing?

For LNP siRNA drugs, dependence on a small number of qualified suppliers is common due to:

• specialized lipid availability and grade controls,
• narrow operating windows for formulation and particle attributes,
• sterile fill-finish qualification and long qualification lead times.

A quantified dependence index by named supplier cannot be produced from the information provided.

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Key Takeaways

• ONPATTRO’s supply chain is structured around LNP component sourcing, oligonucleotide raw materials, sterile fill-finish, and release testing with heavy cGMP and change-control burdens.
• A complete named list of ONPATTRO suppliers (by company and site) cannot be produced from the information provided.
• Practical supply risk focuses on lipid excipient grade consistency, aseptic fill-finish capacity, and cold-chain logistics, with supplier qualification driven by CMC comparability.

FAQs

1. What raw materials are required to manufacture an LNP siRNA drug like ONPATTRO?
2. What elements of ONPATTRO are most sensitive to supplier changes under CMC?
3. Which CMC stages for ONPATTRO are typically outsourced to CDMOs?
4. How do container-closure suppliers affect ONPATTRO stability and release testing?
5. What manufacturing changes can trigger FDA CMC comparability work for ONPATTRO?

References

1. (No citable sources were provided in the prompt.)