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Every biopharmaceutical is unique and products are defined as much by their manufacturing process as their analytical characterisation. Because of this, the development of biologics has many inherent complexities over small molecule projects.
Every biopharmaceutical is unique and products are defined as much by their manufacturing process as their analytical characterisation. Because of this, the development of biologics has many inherent complexities over small molecule projects. The challenge for CDMOs is to maintain product integrity throughout development, as well as the subsequent transfer to manufacturing groups. The conventional approach, which involves segregated development and manufacturing functions, can lead to transfer risk, so it is essential to have integrated functions that have an in‑depth understanding of the process requirements.
Tony Hitchcock is Head of Manufacturing Technologies at RecipharmCobra Bio.
During the development stage of a programme, it is extremely difficult for a service provider to anticipate all of the activities that will be required, as both the behaviour of the product and the process requirements will not yet have been established. The development stage is inherently risky for both the customer and the outsourcing provider, and to mitigate this it is essential for the provider to understand the customer’s critical development milestones and to attain a detailed understanding of project risks. It is then possible to structure a programme of work with milestones and decision points that address these risks. This programme should also be flexible enough to be able to modify planned activities in response to development outcomes.
Development, by its nature, is unpredictable. As such, the planning and co-ordination of multiple projects is complicated and schedules are often short-lived. In the first instance, it is important to have open and transparent communications with customers to facilitate shared decision-making and to ensure that unexpected issues are dealt with promptly with minimal impact to production plans. Project management is a fundamental requirement and the project team should ideally include members of the customer’s development team. It is not possible to mitigate risk by planning for all eventualities during the life of a project, nor would the cost or timelines associated with this be viable. Therefore, the project team must proactively manage risks throughout the project; planning for the near-term whilst keeping the end development goal in mind.
To be able to respond quickly to problems that arise, CDMOs must build flexibility into their personnel, systems and capacity. Developing employees to work across development and manufacturing functions not only allows for the redirection of resource when one team represents a bottleneck, but also supports the development of processes that can be readily transferred to the GMP manufacturing facility with a team who have an in‑depth understanding of the process. Meanwhile, the use of disposable manufacturing solutions, standardised equipment and materials where possible assists in reducing lead times and costs, and also enables the quick turnover of manufacturing campaigns.
Perhaps the most important step is to obtain an in depth technical understanding of the programme before agreeing to budgets and timelines because these can only be realistically decided upon with detailed information about the project.
At the outset, it is also important for both the CDMO and the customer to understand and buy‑in to their respective deliverables. Simple things such as the prompt turnaround of documentation by both parties can have a significant impact on the programme timelines. Equally, detailed study plans and study reports at each stage greatly assist in the progression and management of projects. As with all aspects of the programme, proactive project management both by the project manager and the joint project team is critical, as well as regular meetings and project updates. Finally, the importance of the management and selection of quality subcontractors and suppliers cannot be underestimated.
The biopharmaceutical contract development and manufacturing industry is extremely competitive, particularly following recent rounds of acquisitions and consolidation within the market. Funding constraints during the recession have impacted both customers and CDMOs, thus intensifying the competitive pressure. However, those organisations prepared for risk are better placed to make a project successful.