What are recent developments and milestones at Enzene Biosciences?

Our CDMO setup in India has matured, and we are in the final stages of launching our US manufacturing site in New Jersey. This facility will house two production lines powered by our EnzeneX™ platform, which utilizes our fully connected continuous manufacturing™ technology. Several partners have already signed up, and we anticipate going live in the coming months.  By March 2025, our New Jersey site is expected to be fully staffed with 50 employees and well on track to meet operational goals.

Our discovery labs in India are now fully commissioned, supporting major clients in protein reagents, assay development, and immunogenicity testing.

What are the advantages of fully-connected continuous manufacturing™?

Fully connected continuous manufacturing™ offers unmatched efficiency, reducing both cost of goods and capital expenditure. Our initial US$50 million investment in the US facility enables nearly 1 t/y of production capacity. In contrast, a traditional batch manufacturing setup would require US$200-US$300 million for the same output. Our EnzeneX™ platform, originally scaled at 200-500 L, has expanded to 1000 L, delivering up to 40 kg per batch. The cost efficiency and sustainability advantages are attracting growing industry interest, with over 10 integrated projects executed. In addition to cost benefits, the technology offers 10x increase in productivity and ~50% reduction in carbon emission, while maintaining high quality standards. Regulatory agencies like the USFDA have also provided draft guidelines, signaling increased adoption of this technology in the coming years.

What sustainability initiatives does Enzene implement?

The EnzeneX™ platform itself has a much lower carbon footprint due to its compact design and high efficiency. Our manufacturing suite occupies less than 1,500 square feet while producing up to 40 kg per batch per month. We are focusing on optimizing media usage. Many nutrients are recycled but not reused, so we are leveraging process analytics and spent media analysis to fine-tune nutrient supply. We are exploring media recycling in our perfusion process. There is significant plastic usage in biomanufacturing, and we are actively seeking partnerships to develop solutions in this area.

What major trends are shaping the CDMO industry?

A significant trend post-COVID is the shift toward localized manufacturing, with governments and companies prioritizing regional production. This aligns well with our compact, scalable manufacturing model. We also see evolving dynamics in advanced therapy areas such as gene therapy, mRNA, and antibody-drug conjugates (ADCs). Enzene is actively exploring expansion into these domains to remain a modality-agnostic biologics CDMO.

What role does Enzene play in the growing biosimilars market?

With many biologics coming off patent, biosimilars are becoming increasingly important. The cost pressures that once drove the rise of generics are now influencing biosimilars, and our India-based manufacturing hub provides a cost-effective solution for biosimilar production. Our discovery labs are designed to support early-stage research, focusing on protein reagent synthesis, AI-assisted therapeutic discovery, and rapid turnaround times. AI-generated sequences have great potential, but there’s a gap in validating these leads. We aim to bridge that gap with high-throughput screening platforms that generate lab data in days rather than weeks.

Where do you see the CDMO industry heading, and how is Enzene positioned for growth?

The biotech investment cycle is rebounding after a dry spell in 2024. The CDMO sector typically lags biotech investment by about a year. Now that funding is flowing back into biotech, we anticipate a surge in early-stage deals where CDMOs will play a critical role. Enzene is well-positioned. The biotech pipeline remains strong, and commercial CDMO deals are increasing. New modalities such as CGT, mRNA, and ADCs will continue to expand. Companies that provide end-to-end solutions and innovative technology, like Enzene, will be well-placed to capitalize on these trends.

What are Enzene’s key objectives for 2025?

Our priority is execution. We have a strong deal funnel, and many of these are now being signed and converted into active projects. For 2025, our focus is to ensure we provide top-tier service to our clients, delivering projects on time, maintaining high-quality standards, and expanding industry knowledge on the advantages of fully-connected continuous manufacturing™ over fed-batch or modular-based definitions of continuous manufacturing. From an innovation point of view, breaking the US$40/gram cost barrier for production of mAbs is a key objective this year.