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Accelerate oligonucleotide and peptide products from early discovery to late-stage development & commercialization.

Launching clinical antisense oligonucleotide manufacturing capability in a biologics company

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Over the course of 17 months, Biogen internalized a new manufacturing platform for antisense oligonucleotides capable of producing its commercial and clinical pipeline. As Associate Director of Process Engineering and Manufacturing at Biogen, Dr Sheron Branham is responsible for the operation of their new antisense oligonucleotide clinical and commercial manufacturing facility.

Inspired by the potential impact ASOs could have on unserved patient population, she was driven to help in the mission.  She serves on the site leadership team for Biogen’s RTP facility and has been at Biogen for just over four years.

In this exclusive interview Dr Branham explores the reasons behind the facility and challenges it brought.

 

Why did Biogen decide to internalize a manufacturing platform for antisense oligonucleotides, as opposed to outsourcing?

SB: Several factors were considered in Biogen’s Make vs. Buy decision for antisense oligonucleotides, but three major reasons drove the decision towards internalization.

The first was the strength of our pipeline of ASOs out of the Ionis partnership. We were on the verge of launching our first ASO, Spinraza, and we had a number of additional molecules in development with several more expected throughout the lifetime of our partnership agreement with Ionis.

The second was the worldwide capacity constraint for ASO manufacturing. Limited flexibility, long waiting periods, and high cost to outsource were considered in the decision.

Finally, Biogen’s ASO manufacturing process enabled the use of existing biologics purification and vial filling facilities, limiting capital costs to the installation of upstream synthesis only. Overall, the strategic benefits and cost analysis indicated the best decision for Biogen was to make.

 

What challenges did Biogen face during the construction of its new $23M facility?

SB: There are always challenges associated with any startup, but launching a new manufacturing platform like ASOs in a company that has been protein-centric for 40 years presented some unique opportunities. I will discuss several of them in my presentation, but one challenge in particular was overcoming the lack of internal resources with ASO expertise.

We have ASO expertise in our process development team, which is located in Boston, Massachusetts, however the manufacturing facilities were all to be located in North Carolina. We leveraged external experts throughout the design and construction phase to ensure safety and manufacturability in the new space. However, the manufacturing team was assembled with internal resources from our large and small molecule teams, including myself. We were very fortunate to be able to learn from the expertise of our Ionis and internal development colleagues, who were all very generous with giving their time and knowledge.

We were also able to build in practice time into the schedule on our pilot scale equipment and then on the commercial scale equipment after installation. Even after our first successful GMP batch, we are continuing to learn and build on this baseline of knowledge that we gained in our first year as a team.

 

Where do you see potential opportunities and challenges for the oligo therapeutics field over the next 5 years?

SB: The number of ASOs in clinical development has grown by over 300% in the last five years. As we continue to commercialize more and more ASOs, particularly in larger non-orphan patient populations, the expectations of regulatory agencies and the strain on the supply chain will also increase. As an industry we have an opportunity to align and collaborate to find solutions for single-sourced raw materials, undesirable and unknown side mechanisms, on-line process analytics, and more accessible analytical methods.

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