Building an effective, long-term CMO relationship poses significant challenges. In addition to an open, collaborative spirit, a strong partnership requires a successful technology transfer, a clear understanding by both partners of the key objectives at each project life cycle stage, and effective management of unexpected events.
Factors For Successful Partnerships
A successful program with a CMO requires a detailed plan, a flexible approach, and open, transparent communications. Two fundamental tools that set the tone of the partnership are (1) the manufacturing service agreement (MSA), the road map for launching the project and how to manage when things don’t quite go according to plan, and (2) the quality agreement, which provides greater detail on the operational rules of engagement. Once a program is launched, effective project management and regular face-to-face team meetings are essential for sustaining a strong partnership. Finally, both partners should establish and adhere to positive behavioral norms for team interactions. Managers must clarify these norms, correcting ineffective behaviors early, while building team competencies. These elements help build a high-performing team that engenders the most critical factor for success: a spirit of trust and collaboration.
Case Study 1
As a CMO service provider, Abbott partnered with a sponsor for a recombinant product. Key project objectives included transfer of development activities to Abbott’s Worcester, MA, facility, conversion from a perfusion-based to a fed-batch cell culture process, and implementation of downstream unit operations. Abbott also had to validate a viable process and gain commercial manufacturing approval.
Working cooperatively between the two laboratories, the team efficiently completed process transfer, characterization, and validation. Following commercial approval and demonstration of process performance with numerous batches manufactured, a sudden change in process performance challenged the team’s ability to deliver standard batch yield. Leveraging their strong partnership, the joint technical team was able to troubleshoot the problem and recover the process, delivering 10% more than was previously thought possible.
Case Study 2
As a sponsor, Abbott sought to enhance its security of supply for an approved product by contracting with a CMO for additional capacity. The commercial product had been previously launched at the 6,000L scale and transferred to a second facility at the 12,000L scale. Project objectives included adapting the process to fit the capabilities of the CMO, transferring the project to both a European facility at the 10,000L scale and a new Singapore facility at the 20,000L scale, and gaining regulatory approval at both sites.
Both parties must own the project. The sponsor must set clear performance expectations, and the CMO must demonstrate a successful fit. When starting a process in a new facility, both must jointly navigate the nuances accompanying each unit operation.
Gaining approval requires careful planning and execution. Together, the team defines the process validation master plan, performs a careful process risk assessment, and plans sufficient manufacturing runs to establish confidence in the process and facility performance.
Sustaining optimal performance of the commercial process requires diligence from both sides. Working together as one team, the sponsor, with its detailed product and process knowledge, and the CMO, with its extensive operational experience, must react quickly to problems before they evolve into significant issues.
A central dashboard that captures key performance indicators (e.g. in-process controls, specifications, nonconformances, out of trends, CAPAs [corrective and preventive actions]) at all sites is critical to avoid even minor variations in product quality and ensure interchangeability within the supply chain. When manufacturing in multiple sites, one central team should collate data and tune the process to deliver consistent product quality and eliminate process variability. Coordination of these activities requires a highly organized, dedicated program manager.
Ralph Lambalot, Ph.D.
Lambalot is the DVP of Abbott’s biologics development & manufacturing launch. He has 16 years of experience in numerous roles spanning the continuum of drug discovery, development, and commercial manufacture for both small molecules and biologics.