Right from the Start: Designing Advanceable Formulations and Processes at Phase I

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Abstract:  

The primary criteria for successful drug development and commercialization have long been established: any new pharmaceutical product must be safe and effective, and it must be both manufacturable and commercially viable. Historically, demonstrating safety and efficacy was sufficient to advance a drug candidate through clinical trials. However, as timelines have accelerated and the market continues to become more competitive, the risks associated with manufacturability and commercial viability have drawn more attention, and drug developers are increasingly seeking approaches to address these concerns at earlier stages of product development. This shift in emphasis and timing demands an appropriate deployment of tools, processes, and methods, which means establishing partnerships with contract development and manufacturing organization (CDMO) partners who share this vision. In this new landscape, success hinges on the ability to navigate the intersection of science, technology, and commercial readiness, driving an increasingly proactive and agile approach to drug development.

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‍Key Learnings:

• Establishing flexible formulations and processes can circumvent the need for relative bioavailability (RBA) studies by eliminating the necessity to overhaul the formulation and process as the candidate progresses into later clinical trials.

• Reducing development time by a year or more can translate into the preservation of hundreds of millions of dollars in potential revenue, considering the finite duration of patent protection.

• Failing to consider advanceable formulations and processes during the early development phases not only jeopardizes a product's potential value but also diminishes its marketability.

• Subsequent scale-up of suboptimal processes and formulations for late-stage and commercial production increases the risk that reformulation will be necessary.

• It is essential that the formulation and process are sufficiently flexible to adapt as a program evolves through clinical development toward successful commercial manufacturing.

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Early-Phase Commercial Readiness at Serán Bioscience

At Serán, discussions with clients about clinical development strategy and commercial product design typically begin before phase I. Serán’s team works with the sponsor to define a target product profile (TPP) through a meticulous evaluation of the indication, the intended patient population, and other integral aspects of the client's strategic vision. As the API is characterized to determine the most suitable formulation technology and drug product design, the team must thoughtfully consider the final TPP, as it is the foundation for the entire development path and strategy, while identifying which aspects of the TPP must remain flexible during early clinical development.

All these pre-registration activities are being executed using the product life cycle approach as part of Stage 1 Process Validation (PV) as stipulated by global regulatory agencies.  This maximizes the utilization of stability and analytical method data across all phases of clinical development to the commercialization stage, leading to real savings in terms of time, resources, and finances.  Additionally, this approach provides for identification and control of critical quality attributes, which in turn provides for seamless execution of PPQ activities to support commercial launch.

‍To Learn more about Serán's formulation development and dosage form design capabilities, contact us today.

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Seran's Emerging CMC Paradigm Shift©