BIO 2024 spotlight: Exothera's fast-track solutions for mRNA manufacturing

By Isabel Cameron

- Last updated on GMT

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© Getty Images

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Darren Leva, chief business officer at Belgium-based CDMO Exothera, is at the forefront of the company’s efforts in advancing mRNA-based therapies.

As BIO International kicks off this week, we had the opportunity to discuss Exothera's dedication to these innovative therapies and the new technologies they are unveiling at the event.

BPR: What new products or innovations is your company showcasing at BIO 2024 this year?

At BIO 2024, we are excited to showcase our world first continuous-batch RNA manufacturing offering, Ntensify. Developed by our sister company Quantoom Biosciences, the Ntensify platform fast-tracks the production of higher quality and more cost-effective RNA therapeutics, delivering significant advantages at both small and large scale.  

We’re also pleased to launch our Fast-Track RUO package, which offers an expedited RUO mRNA synthesis service with a 4-week turnaround time. This fast-track service is ideal for projects with tight deadlines or when rapid access to mRNA is critical. The package utilizes our automated Ntensify system, ensuring that the process always stays the same, regardless of quantity. As a result, companies can start with small quantities of RNA for internal screening use and seamlessly progress to GMP manufacturing without scaling up or worrying about changing reagents or processes, saving time and money. 

BPR: What are you hoping to achieve from the event?

Our goal is to connect and share insights with biotechs, pharmaceutical companies, and industry leaders who are pioneering mRNA-based therapies and developing viral-based clinical candidates. In particular, we aim to raise awareness about the transformative potential of our offer in helping biotechs to fast-track the progress of their mRNA therapeutic, while also making it more cost-effective.   

BPR: How does your company stay ahead of industry trends and developments in the pharmaceutical sector?

There are many trends within the sector that Exothera is staying ahead of, these include automation of manufacturing processes, expansion to emerging RNA modalities and adopting flexible pricing models. 

Looking ahead, the collective impact of innovative technologies such as mRNA, coupled with decentralized manufacturing and standardized, automated manufacturing processes, holds immense potential for transforming global health outcomes. The Ntensify technology is at the forefront of these exciting advancements and as a result we can ensure equitable access to vaccines and therapeutics on par with high-income countries, without enduring the same lengthy growth and development cycles. We have made significant strides in recent years, and the ability to tailor custom therapeutics and target specific patient needs on a global scale has never been more achievable or cost-effective. 

BPR: What challenges are you currently facing in the pharmaceutical market, and how is your organization addressing them?

One of the key challenges in the mRNA therapeutics market is the lack of standardized and scalable manufacturing processes. Traditional approaches often struggle with batch-to-batch variability, lengthy tech transfers, and regulatory hurdles. Exothera, in partnership with Quantoom Biosciences, addresses these challenges by implementing standardized protocols, robust analytical methods, and advanced automation from the earliest research stages. This proactive approach ensures consistent product quality, streamlined scale-up, and seamless regulatory compliance throughout the development lifecycle.

Additionally, in the context of global healthcare preparedness, the ability to rapidly scale up production and respond to emerging health threats is critical. The automated nature of the Ntensify technology minimizes the need for extensive training and infrastructure, making it accessible to a wider range of manufacturers. This approach is particularly relevant for instance for the mRNA Technology Transfer Programme initiated by the World Health Organization (WHO), which aims to achieve equitable vaccine access for low- and middle-income countries (LMICs) — Ntensify enables globally localized production of mRNA therapeutics and vaccines with a reduced reliance on imports.

BPR: What strategies does your company employ to ensure the quality and safety of its pharmaceutical products?

The standardization and automation of the Ntensify process supports the high quality and safety of products. More specifically, the continuous-batch RNA development process combines in vitro transcription (IVT), co-transcriptional capping, and single-step purification using magnetic silica beads. The well-defined protocols and automated processes streamline the journey from early research to commercial production, ensuring consistent quality and minimizing batch-to-batch variability. 

BPR: Can you provide insights into any regulatory changes or compliance issues that are impacting your business?

Regulatory agencies like the FDA and EMA have stringent guidelines and expectations for mRNA therapeutic development, with a strong emphasis on well-defined processes, comprehensive documentation, and adherence to GMP standards. Exothera’s standardized manufacturing approach aligns seamlessly with these requirements, facilitating smoother regulatory submissions, inspections, and approvals. By establishing a robust quality management system and proactive compliance right from the RUO stage, we can navigate regulatory pathways more efficiently and mitigate compliance risks. Our sister company, RLM Consulting also provides regulatory affairs insight and support at all stages of the medicinal product development. 

BPR: Can you discuss any plans for expansion or market growth in the pipeline?

We recently established a new site in Andover, Massachusetts, meaning that Ntensify is also now available to biopharma companies in North America for the first time. 

Innovators can visit the site and see the equipment firsthand. We can produce research-use only (RUO) material to enable the down selection of drug candidates, produce material for in-vitro testing, or larger batches that could support small in vivo studies. Through our expansion into the US, developers of RNA therapeutics and vaccines will have access to the most advanced RNA production processes and equipment, allowing for fast delivery of therapeutics and vaccines to their patients on US soil.

BPR: What sets your company apart from competitors in the pharmaceutical industry, and what value do you offer to your customers?

As a specialist viral vector and nucleic acids CDMO, founded by an inspiring leadership team of inventors, we offer access to genuine game-changing, innovative technology. This includes our most recent launch, the world-first continuous-batch RNA production platform, Ntensify, powered by sister company Quantoom Biosciences. 

Combined with our attentive, flexible service and scientific expertise we’re uniquely positioned to help biopharma companies and academic researchers at all stages of their drug development journey, innovate and realize their vision.

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