Scaling biologics for commercial: The importance of adopting a customer-centric approach
In this blog, Bora outlines the key challenges biologics developers face on the journey towards commercialization and highlights the importance of finding a development and manufacturing partner adopting a customer-centric approach to overcome scaling issues.
Scaling challenges in the dynamic biologic market
The demand for biologics has risen significantly over the last decade, with the global biologics market more than doubling in size, growing from $149 billion in 2010 to an estimated $511.89 billion in 2023 [1]. This has, in part, been driven by advancements in biotechnology and manufacturing processes, such as improvements in cell culture and expression systems resulting in higher titers, and advances in downstream purification, that have enabled the development of more effective and efficient biologics. As the market continues to expand, drug developers and manufacturers are under pressure to meet growing demand while navigating the complexities of ensuring a smooth and seamless scale-up. Critically, scaling success relies on drug developers maintaining similar product quality from small-scale to large-scale. However, changes in bioprocess parameters can impact cell growth and metabolism, product characteristics such as glycans species and post-translational modifications. These can subsequently affect the critical quality attributes (CQAs) of the biologic. Having a thorough understanding of how any changes in bioprocess parameters when scaling could impact the CQAs of the biologic is imperative to the success of the project. Drug developers must also overcome scaling challenges, such as ensuring process robustness for scalability and effectively managing the cost of goods and supply chains.
Embracing a client-centric approach to scaling
With the above challenges in mind, many biologics developers are looking to expert contract development and manufacturing organizations (CDMOs) to:
- Enhance process and manufacturing technologies for robustness
- Optimize production for both current material needs and future market demands
- Ensure a seamless transition from clinical to commercial production.
This can only be achieved if the CDMO works closely with its client’s program managers and are in-tuned with clinical and patient needs, which will progressively increase. Many benefits can be gained by partnering with a CDMO that ensures efficient and transparent communication and collaboration with its clients:
- Real-time feedback for optimization With open communication with clients, CDMOs can use real-time feedback to iteratively improve the production process, consequently enhancing both efficiency and quality. By enhancing productivity and yield, the final bioreactor volume needed at the commercial scale can be reduced, helping to minimize production costs. This close interaction also facilitates a deeper understanding of the customer’s target market, enabling the development of tailored manufacturing strategies that better meet end-user requirements.
- Rapid problem solving By working closely together, CDMOs and their biotech clients can share and leverage insights from in-house databases to refine production parameters, CQAs, and analytical methods to identify and resolve quality issues rapidly to ensure therapies reach patients sooner.
- Proactively de-risking processes CDMOs can pre-emptively identify potential scalability challenges and address them before they become critical issues by integrating biotech customer insights into the manufacturing process. This will be supported by performing scale-down model studies to assess the process scalability and identify potential challenges and equipment capabilities during scale-up. A proactive problem-solving not only reduces downtime and delays but also optimizes resource allocation and production planning.
Aligning with the customer’s clinical and commercial strategies not only ensures compliance with regulatory standards but also minimizes the risk of delays, facilitating a smoother market entry for biologic products. By adopting a client-centric approach, CDMOs can therefore help ensure that manufacturing capabilities are fully aligned with commercial objectives, thereby reducing risks and improving the overall success rate of product launches.
Working together from early in the development process
To effectively manage the evolving risks that emerge during the transition of a biologics project from pre-clinical to commercial stages, biotechs should partner with an experienced CDMO partner early on to gain the fullest advantage:
- Expertise and experience in biologics CMC: With many years of experience supporting the development and manufacturing of a wide variety of biologics projects, CDMO partners will be aware of the many potential scaling challenges ahead and have strategies in place to navigate them. They can also help to identify how productivity and yield could be enhanced, enabling biotechs to reduce the need for high bioreactor volumes at commercial levels.
- Accelerated development timeline: CDMOs offering integrated and robust platforms, as well as ensuring seamless collaborations between different functional teams can help to streamline timelines to quickly move their client’s projects from research stages to CMC preclinical development and onto GMP manufacturing.
- Access to specialized in-house analytical capabilities and resources: Due to the nature of complexity in biologics, in-depth protein characterizations play a critical and essential role in moving development works quickly and smoothly. CDMOs offering in-house analytical capabilities can help to ensure CQAs are met, providing immediate support, with no outsourcing, no waiting and no compromise in timelines.
A customer-centric biologics CDMO partner
At Bora, we understand the importance of open, continuous communication and collaboration with clients to the success of the development and manufacturing of biologics. We emphasize a client-centric approach with strategic communication to enable swift decision-making which allows us to effectively conduct risk assessments and provide agile mitigation strategies. Through weekly and bi-weekly joint customer management committee (JCMC) meetings and 24-hour support, our subject matter experts maintain open and continuous communication and provide problem-solving solutions with clients to ensure the scale-up process is smooth and successful. Bringing expertise in technical transfer activities, including gap analysis, equipment capability assessments, processes and analytical methods optimizations, we ensure that every phase of the project aligns with the client’s specific needs and expectations.
Find out how we can help support the scale-up of your biologic
https://boracdmo.com/contact-us/
