The challenge
Exciting advances in oligonucleotide therapeutics are driving demand for rapid oligo production from manufacturers.
Exciting advances in oligonucleotide therapeutics are driving demand for rapid oligo production from manufacturers.
Nitto Avecia partnered with Arcadis to expand their operations, designing a facility that can meet this demand now and in the future.
Nitto Avecia partnered with Arcadis to expand their operations, designing a facility that can meet this demand now and in the future.
Oligonucleotide (oligo) therapeutics—treatments that use short pieces of DNA or RNA, called oligonucleotides, to target and control specific genes within a cell—offer a novel approach to treating diseases that were previously difficult to manage, such as central nervous system disorders and cancer. While the first approval of an oligonucleotide for medical use came in 1998, in recent years therapeutic oligos have emerged as a rapidly expanding category of drugs. New technology advances have opened the field to major progress in the treatment or cure of diseases, holding great potential for further development in human medicine.
As a result of this progress, established oligo manufacturers, like Nitto Avecia, were required to expand their operations to meet current and future demand from pharmaceutical firms to manufacture oligos in the volumes and purities needed for human pharmaceutical use.
Nitto Avecia quickly recognized this market situation and began the master planning process for a major expansion at their Milford, Massachusetts site in 2020. Arcadis partnered with them on the design for the facility, adhering to a philosophy which anticipates, and accommodates, continual process change, growth in scale of oligo production, and a diversity of workflow needs for different products.
From the facility layout, which was designed to allow for quick fit out or expansion and flexibility in how the space is used, to various process advancements and utility improvements implemented within the facility, every aspect of the plan was designed to enhance flexibility, safety and process efficiency to support the rapid deployment of new oligo drugs. Sustainability was also a key aspect in the design, incorporating solvent recycling, disposable plastic waste reduction and energy use reduction measures in the facility’s operations. An independent energy study performed by the Vermont Energy Investment Corp (VEIC) concluded that the facility’s HVAC heat recovery system, which recovers heat from discharged air and uses the energy to either preheat or cool incoming air, is key to reducing the facility’s carbon footprint. The Milford facility is expected to reduce its energy use by 20% compared to the VEIC’s baseline facility.
Despite conceptual design for this project beginning at the onset of the COVID-19 pandemic, the project team successfully managed supply chain interruptions and remote work to deliver the project in 24 months, completing the facility as many contract manufacturing organizations (CMOs) are still in planning phases.
Oligo therapeutics represent a new generation of disease treatment, from cancers to neurodegenerative and respiratory disorders, but to bring these therapies to market, it’s imperative that CMOs have the capacity to support oligo drugs now and in the future. By implementing and enabling current technology advancements while positioning the site for rapid growth and future manufacturing improvements, Nitto Avecia’s first-in-class facility is helping to lead the way.