Can you introduce CMIC CMO USA?

CMIC CMO USA is a CDMO company launched in 2007 in the US, running a plant in Cranbury, New Jersey, now with a facility of 265K sq. ft.

CMIC was the first company that started CRO business in Japan, and is currently offering a full range of pharmaceutical functions, but not owning products (except several Orphan drugs). This ensures CMIC never compete with its clients, so clients will comfortably outsource to CMIC. While some companies rival CMIC in specific areas, no competitor offers the full suite of services which CMIC provides.

CMIC CMO USA brings high-quality Japanese pharmaceutical manufacturing to the US, while also helping US companies enter the Japan market. CMIC’s full pharmaceutical capabilities give US pharma companies a one-stop shop for registration and PMDA approval. How is business continuity planning informing CMIC’s business strategy?

Companies have discussed business continuity planning (BCP) for years, but only few imagined events like COVID-19 would occur. CMIC was at the forefront of Covid-19 pandemic response in Japan and felt firsthand at the importance of BCP.

When it comes to BCP, location is critical. The two major disruption risks are natural disasters and political instability. Ideally, companies would have manufacturing plants across regions to reduce risks. However, this is easier said than done. Most pharmaceutical companies lack the financial muscle to operate their own plants globally. In practice, it is a challenge involving expensive, and time demanding tech transfers between sites. At the same time, for companies to sell the same products worldwide, approval from multiple regulatory authorities which often requires international inspections are necessary.

CMIC CMO USA is leading and exploring the global implementation of continuous manufacturing in GMP environment as CDMO. This enhances agility and helps our clients pivot efficiently under market or regulatory pressures. We will pursue this and aim to contribute to the industry BCP. Why is continuous manufacturing the keystone piece of BCP?

While the concept of global BCP makes sense, it is far from being widely adopted. For example, Batch manufacturing has multiple implementation stages, starting from bench (1 Kg) and scaling up to pilot (>40 Kg), commercial (>250 Kg). At each implementation scale, the process must be characterized. At each scale-up event, there is increased risk of failure, and this development process takes time. On the other hand, continuous manufacturing operates on time rather than scale, and development is performed directly at the commercial scale. It enables the company to examine many product compositions and process parameter choices in a very short time.

Moreover, critical quality data can be obtained and analyzed in real time and used to control the process. Faulty product units can be diverted to scrap without compromising the entire lot, while in batch, humans usually handle testing manually. Continuous manufacturing drastically cuts errors, speeds up changeovers, and lowers waste, it is more cost-effective with efficient operation.

Companies that have implemented mirror Continuous Manufacturing lines can quickly switch locations during natural disasters, ensuring uninterrupted production. This will encourage the industry to expedite having secondary and tertiary manufacturing sites as backup which directly connects to the BCP concept. What are the greatest challenges in continuous manufacturing and how is CMIC CMO USA addressing them?

Broad implementation requires overcoming three challenges: (1) equipment is expensive, (2) few know how continuous manufacturing works, and (3) implementing new lines can take several years. Leaders such as J&J, Pfizer, Vertex and Eli Lilly keep their expertise in-house, leaving the rest of the market in the dark. Some companies without such in-house expertise implemented lines but gave up after failed attempts. Without serious human capital and the right equipment, implementation often fails.

CMIC CMO USA is working to ease these issues. We partnered with Rutgers University in October 2023, supported by the State of New Jersey. Through this partnership, we access top-tier expertise, led by Professor Muzzio, ensuring a steady flow of knowledge and support with access to a wide range of characterization, testing and process development, equipment and models. To spread continuous manufacturing worldwide, the industry needs standardized equipment. We have aligned with Fette Compacting (Fette) who developed continuous manufacturing equipment, which we believe can be standardized ensuring reliability, superior quality, and accelerated development. With standardized manufacturing systems, regulatory approval would become easier and faster. Fette continuous manufacturing equipment has arrived at our site in US already. Together with Rutgers and Fette, CMIC is aligned with a shared goal of spreading continuous manufacturing. What is CMIC CMO USA’s market differentiator and goals for the next 24 months?

Our goal for 2025-2026 is bringing our concept to market, executing for our customers who are counting on this strategical focus of continuous manufacturing.

CMIC is truly a leader in Japan and our presence here in the US is continuing to grow. Continuous manufacturing is key to our US strategy, differentiating us in the market.

We established the conceptual base through a MOU with Rutgers and a strategic alliance with Fette. Rutgers brings deep technical expertise and proven research capabilities with academic resources in continuous processes, helping us refine formulations, validate new methodologies, and streamline scale-up bringing more robust, cost-efficient processes in a shorter time. Fette supplies state of the art advanced equipment, the FE CPS makes high-throughput, consistent production viable. CMIC CMO USA brings high-quality standards cultivated over many years with Japanese pharma. Integrating our strength as partnership is a clear advantage, ensuring a stable path toward standardized, repeatable processes that can replicate globally.