The understanding of a “successful” study drug can vary greatly; for example, a study drug in the pharmaceutical field may be clinically effective, but potentially too expensive to manufacture at scale viably.
Image Credit: hVIVO
Drug development often progresses from one phase to the next without considering long-term feasibility, such as scalability, cost-effectiveness, and market access. Sustainable success is assured by implementing future-proof strategies from the outset.
In a recent interview with Erik Gout, Director of Chemistry, Manufacturing, and Controls (CMC), and Azra Gholami, CMC Consultant at Venn Life Sciences, hVIVO looked to explore these issues further.
These two experts shared their expertise in process optimization and formulation development, emphasizing the importance of considering long-term implications beyond the development phase to ensure sustained success.
Venn Life Sciences’ consultancy boasts extensive expertise in biologics and small molecules, each of which necessitates the implementation of a distinct optimization approach.
Biologics development is broken down into upstream and downstream processes, with the upstream process generally defining the cell line before Phase 1. This is rarely changed after it has been defined, because modifications may require a total redesign of the downstream purification. The discussion here focuses on small molecules.
Ensuring scalability via optimization and formulation development
Phase 1 clinical development must focus on the evaluation of drug safety, generally done using a basic or no formulation. Small molecule formulation tends not to be optimized, however, and the drug substance’s synthesis route may still be under development.
The feasibility of the drug substance process and formulation must also be assessed for use in future Phase 3 and commercial production. This is done when transitioning from Phase 1 to Phase 2, and it is essential to optimize both the drug substance and the drug product at this stage, while also considering the final formulation and process.
Erik stresses that it is vital to align development with long-term goals, advising clients to consider both scalability and the cost of goods at an early development stage.
“It’s not just about reaching the next phase,” he states. “Early decisions should assess whether the formulation can scale effectively.”
He continues, “Key considerations include cost-efficient excipients, adaptable production processes that allow for Contract Development and Manufacturing Organisations (CDMOs) changes, and standardized methods to support a smooth transfer to commercial manufacturing.”
“For (bio)pharmaceutical clients using separate CDMOs for drug substance and drug product, Venn can manage both to ensure alignment. We offer consultancy on decision-making, testing, process control, risk management, and logistics.”
“While CDMOs have scientific expertise, Venn bridges knowledge gaps – like stability differences – by facilitating information exchange. We guide stability testing to ensure shelf life and help define critical manufacturing parameters through scalable process controls and risk management.”
The importance of mitigating risks
“Our most important key services include process troubleshooting and risk management,” explains Azra. “From the outset, we proactively identify and mitigate risks associated with the manufacturing process. Mitigating risks of unstable products can be achieved through process control and selecting the right packaging material.”
“The choice of packaging – whether opting for cost-effective or more specialized materials – can significantly impact the cost of goods during commercial production. Similarly, transport conditions, like storage at 5 °C or lower versus room temperature, play a critical role. Storage at room temperature will generally be more cost-effective in the long run. Ultimately, the goal is to minimize unnecessary complexities while optimizing for cost efficiency and quality.”
Balancing perfect versus the real world
A gap often exists between what can be achieved technically and what is commercially feasible. A balance must be struck between innovation and feasibility in order to ensure long-term success.
(Bio)Pharmaceutical companies are advised to take a strategic view from the outset, focusing on commercial outcomes rather than solely short-term goals. Aligning early informed decisions with long-term objectives will significantly improve the likelihood of achieving sustainable success.
Venn offers expert guidance on process optimization and formulation development, supporting its clients in identifying potential obstacles in future development phases while maintaining a clear focus on the overall commercial goal. For example, this includes evaluating storage conditions, transport, and associated costs.
Acknowledgments
Produced from materials originally authored by hVIVO.
About hVIVO
hVIVO is a full-service early phase CRO offering end-to-end drug development services from preclinical consultancy through to Phase III clinical trials, including world-leading end-to-end human challenge trials services. With decades of experience in rapidly delivering data for our global client base, our team brings together strategic insight and operational expertise to deliver a variety of clinical study types across multiple locations.
To support rapid study start-up and reliable delivery, our dedicated recruitment teams in Germany and the UK provide direct access to both healthy volunteers and patient populations. This is complemented by our integrated drug development consultancy, as well as our infectious disease and immunology laboratories and biobanking services.
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