Integrated API & Drug Product Development
Adaptable Continuous Manufacturing Starting Points And Strategies
CONTINUUS Pharmaceuticals envisions a world where all small-molecule drugs are produced leveraging Integrated Continuous Manufacturing (ICM), delivering safer and affordable drugs within a more resilient supply chain. By connecting each step, from chemical synthesis to final dosage, into a single, integrated process, we help deliver critical therapies to patients more quickly and reliably.
But wholesale change does not happen overnight. Therefore, CONTINUUS supports strategies for adopting ICM at various stages in a pharmaceutical product’s lifecycle and implementing continuous unit operations in a stepwise manner.
Two Entry Points—Existing Products and New Drug Entities
While new drugs are ideally developed using continuous approaches, continuous manufacturing is being increasingly adopted for approved drugs on the market. Considering both of these options will enable a stronger and more resilient pharmaceutical supply chain.
Retrofit and Reformulate Legacy Drug Products
For drugs with long lead times, over-reliance on offshore production, or increasing cost of goods, ICM can offer an attractive alternative:
- Reduce the cost of goods by 30–50%
- Trim months-long processing times to a few days
- Enable regional, on-demand manufacturing
- Improve quality control through real-time analytics
- Increase sustainability through decreased energy and solvent use
Implementing continuous processing for an existing product typically involves post-approval changes and potentially bioequivalence studies; however, the established safety and efficacy profile helps mitigate risk. In addition, the FDA and other leading regulatory agencies have provided guidance and established specific teams to facilitate the adoption of continuous manufacturing.
Continuous from the Start
Introducing ICM early in development unlocks the greatest strategic value, enabling a fully scalable, regulatory-aligned process from day one. ICM simplifies scale-up, ensures product consistency, reduces risk, and can shorten FDA review by months, accelerating time to market and delivering long-term operational efficiency. In this way, patients could have earlier access to the life-saving medications they need.
For new chemical entities, ICM can be introduced as early as Phase I. Starting with continuous processing from the outset means:
- No scale-up and associated complications; longer runtimes achieve increased scale
- Consistent process data from early development through launch
- Streamlined validation
- Quicker regulatory review
- Data published by FDA demonstrated review time reductions of 6-8 months for applications with advanced manufacturing
- Flexible production for fluctuating demand
Whether you’re redesigning processes for an existing therapy or developing a new drug product, CONTINUUS provides an advantage, built for time- and cost-efficiency, quality, and long-term sustainability.
Advanced Manufacturing Expertise to Guide Process & Formulation Development
We offer fully integrated process and formulation development services spanning from API synthesis to final dosage form, all enabled by our proprietary ICM technology.
API Process Development
Using proprietary modular flow chemistry, crystallization, and continuous filtration/drying unit operations, CONTINUUS develops robust synthetic routes optimized for yield and purity.
Formulation Development
We work with you to develop formulations that integrate with your upstream operations. Continuous granulation, extrusion, injection molding, tableting, and coating steps are seamlessly integrated to produce high-quality tablets. The platform supports high-potency APIs, challenging solubility profiles, and precision dosing, as well as other final dosage forms (e.g., sterile injectables).
Modular, Plug-and-Play Unit Operation Integration
Integration sits at the heart of our value proposition. All unit operation processes are designed for flexible configuration and re-configuration, allowing the process to be quickly modified for each molecule and adjusted over time.
Process Analytical Technology (PAT) & Control
The incorporation of real-time monitoring and advanced control systems ensures product quality and enables rapid development cycles. This built-in quality framework supports Quality by Design (QbD) strategies and regulatory alignment from early phases of drug development.
Plug-and-Play Unit Operations & Supporting Technologies
CONTINUUS’s modular, plug-and-play unit operations are engineered for seamless integration and rapid configuration. These units can operate as part of an ICM line or be implemented individually, enabling flexible deployment tailored to each program’s needs.
Join the CONTINUUS Revolution
Learn how Integrated Continuous Manufacturing will transform your supply chain by reducing the cost of goods, increasing product quality, enhancing sustainability, and accelerating your path to market.