OLIGO MANUFACTURE

The Partner of Choice from Pre-Clinical to Commercial Supply

At Avecia, oligonucleotide manufacture is our core competency. As the first CMO to serve the oligonucleotide therapeutic market, we’ve been building experience and technical expertise for over 20 years. We have the flexibility to produce anywhere from your first 50mg of pre-clinical material, to hundreds of kilograms in support of advanced trials or commercial supply. And as an organization dedicated to continuous improvement, our manufacturing practices have evolved and advanced to meet the changing oligo market.

Avecia’s Manufacturing Advantages

Late Phase and Commercial Product Experience

Avecia has been in a position to support the commercial launch of oligonucleotide products since 2005. We are the only oligo CMO with a commercial product in our portfolio, and we have completed four process validations in support of late phase, pre-approval, and launch activities. At Avecia, we don’t just have the capacity for late phase and commercial products, we have both the knowledge and the experience to support the additional needs associated with them.

Security of Supply with Two Facilities

Avecia operates two FDA inspected CGMP facilities in the United States, providing additional security of supply for customers and programs at all phases. The Milford, Massachusetts, headquarters includes mid to large scale manufacturing assets and suites, development and analytical laboratories, as well as on-site stability storage and testing. Our Cincinnati, Ohio facility has additional mid to large scale manufacturing assets with the accompanying development and analytical services, and is home to Avecia’s pre-clinical manufacturing service, OliGrow.

Asset Scale Range

Avecia has a wide range of asset scales available and can offer complete continuity of supply at scales from 50 mg per batch through our OliGrow® program, up to multiple kilograms per batch with our large scale and commercial capabilities. Our installed capacity is rated at hundreds of kilograms per year and we have ample space for further site expansion. This installed and latent capacity provides enormous value to customers who are anticipating a substantial ramp up in commercial demand in the early post launch years.

Dependable Supply Chain

Vendor audits, supply agreements, second sourcing of key materials, and capable handling of customer supplied reagents are some of the essential components of Avecia’s reliable supply chain network. These elements work together with our internal storage and testing controls to ensure the quality and availability of raw materials for manufacture.

Freedom to Operate

Our intellectual property portfolio gives us access to a wide range of oligonucleotide processes, allowing us to operate freely within the oligo manufacture space. We have acquired this through both licensing agreements, as well as our own intellectual property, of which we have patents available for licensing. Click here for a complete list of patents available from Avecia for licensing, or contact us for more information.

Our Manufacturing Assets

Avecia's manufacturing capabilities offer a wide variety of scale ranges and options giving us the flexibility to match your needs:

  • Facilities designed to support pre-clinical, clinical and commercial needs of our customers;
  • The ability to provide non-CGMP and CGMP work from small scale [mg] to large scale [multi kg];
  • CGMP production facilities that include:
    • HEPA filtered manufacturing suites
    • Multiple CGMP manufacturing trains at each location
    • Large range of synthesis and downstream scale capabilities

Our key operational assets include:

Synthesis (Scale range from single mmols up to 900 mmol)

  • 8 AKTA OligoPilot 100
  • 2 AKTA OligoPilot 400
  • 1 Mid scale OligoProcess
  • 1 Mid scale AKB Synthesizer
  • 1 Large scale OligoProcess

Chromatography (Scale range from single mmols up to 900 mmol)

  • 2 Small scale High pressure systems
  • 6 Small scale Low pressure systems
  • 2 Mid scale High pressure systems
  • 2 Mid scale Low pressure systems
  • 2 Large scale High pressure systems
  • 3 Large scale Low pressure systems

Ultra-filtration (Scale range up to 2700+ mmol)

  • 2 Small scale UF skids
  • 3 Large scale UF skids
  • Flexible scale UF apparatus (Millipore, Sartorius, Pall Filtron)

Freeze-drying

  • 3 Small scale systems
  • 4 Mid scale systems
  • 2 Large scale systems

Thin Film Evaporation (Large Scale)

General inquiries and sales: oligoinfo@avecia.com | oligrow@avecia.com
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