Continuous Manufacturing And Late-Phase Strategy: The Time Is Now
By Doug Hausner, Thermo Fisher Scientific
Continuous manufacturing has revolutionized most industries. Now it’s pharma’s turn. With competitive pressures to speed the delivery of safe, effective medicines to market, technologies and innovations that add efficiency to the drug development process without adding unnecessary risk are highly sought after. Continuous manufacturing meets these criteria and adds additional value through enhanced product quality and safety, and decreased waste. With respect to oral solid dosage products in particular, new research suggests that continuous manufacturing leads to higher net present values than continuous manufacturing relative to batch processing.
Despite these advantages and the urging by regulatory agencies to adopt continuous manufacturing to improve the quality and control of drug products and produce a more flexible supply chain, industry uptake has been slow. The hesitation has been attributed to the significant financial investment required to build continuous manufacturing capabilities or retrofit a batch plant, uncertainties about regulatory and compliance issues, workforce and operations concerns, and a market climate that has consistently favored research and development investment over manufacturing investment.
The tide is changing, however. A number of approved drug products produced via continuous manufacturing, either exclusively or in combination with batch manufacturing, have come to market in recent years, demonstrating both the feasibility of the technology and its production benefits. At the same time, outsourcing partners have begun to offer continuous manufacturing capabilities and expertise, removing some of the financial obstacles and improving the business case for adopting the technology.
This report discusses recent progress in continuous manufacturing and provides guidance for answering three key questions related to the implementation of continuous processing for late-phase development of small molecule oral solid dosage forms:
- Is our product the right fit for the technology?
- What is the optimal route and timing for technology adoption?
- What are the critical considerations for reaping the most benefit from the technology?
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