By Robert Di Scipio, Aegis Analytical Corp.
With contract manufacturing on such a rapid rise, the industry needs to identify best practices for maintaining and improving quality and process management across outsourced manufacturing networks. However, many sponsor-CMO contracts are inadequate in the quality data-related provisions as they fail to properly address the rights of a sponsor or its contractors to directly monitor processes and receive process data.
Historically, sponsor-CMO contracts have been written and/or negotiated by colleagues outside of manufacturing/quality roles who are focused on pricing, legal aspects of the relationship, and technical product specifications. Agreements may not always provide the sponsor the right to proactively monitor processes and access the process data necessary to conduct the level of analysis needed for investigative analysis and quality by design (QbD) and process improvement initiatives. Without those rights, tech transfer to another CMO or a captive sponsor facility may be quite difficult. The sponsor’s manufacturing and quality teams will be challenged after the contract is signed to obtain process data if it was not provided for in the agreement.
Obstacles To Avoid
There are several obstacles to data sharing in the sponsor-CMO relationship. The most common is that many CMOs view the process data as their own intellectual property and are reluctant to share raw process data and “their” analytical reports with the sponsor. In addition, CMOs may not have the data aggregation and analytical tools necessary to support the sponsor’s desired efforts around QbD, process understanding, and other quality-related initiatives. Lastly, there may be IT challenges that impair the ability to share agreed-upon data in the appropriate time frame.
As the FDA continues to clarify the need for sponsors to demonstrate control over their CMOs, it is imperative that sponsors and CMOs agree on the appropriate level of data and analytical collaboration as well as the adoption of the appropriate supporting technologies. As the contract manufacturing business grows, some CMOs are differentiating themselves by advertising their 1) investment in leading data aggregation and analytical tools and 2) willingness to be transparent with their sponsors about all aspects of their process and products.
Considerations for Sponsor-CMO Agreements
CMOs and sponsors both will benefit from contracts that provide for data sharing and analytical collaboration. Given timely access to the right process data, a sponsor can collaborate with a CMO to identify process trends and apply corrective actions that serve both parties’ interests.
Specific contract provisions that support the enhanced collaboration include:
Data ownership: Specify who “owns” the quality and process data.
Data access: Specify who can access the data and what types of data are required (e.g. discrete, continuous, event, etc.) to enable better process understanding. Agree upon the frequency and format of the data exchange to avoid “spreadsheet madness.”
Build in flexibility: Specific data parameters for monitoring may not be clear at the start of a sponsor-CMO relationship. Critical process parameters (CPPs) and key performance indicators (KPIs) may need to be based on hypotheses and refined through monitoring. The contract should allow for dynamic and continuous changes in data-sharing requirements. Build flexibility into the contract for modifying data requirements and include the ability to retrieve and review historical data.
Determine data review timelines: Specify how often the organizations will reevaluate and revise parameters and processes (e.g. every six months).
Consider requiring technological improvements: Encourage migration from paper-based data records to electronic solutions that gather data from disparate systems. Both parties will benefit from lower staff costs and more reliable data upon which to base decisions. Agree on confidential data elements. CMOs work with multiple sponsors and have to be sensitive to safeguarding proprietary information while providing reasonable data access to sponsors.
Process intellectual property: Specify who “owns” enhancements to the original process.
Most regulatory agencies want outsourced manufacturing to be integrated into the operations of the sponsor organization. Including comprehensive collaboration and data-sharing provisions in the sponsor-CMO contract can help satisfy regulatory requirements across disparate manufacturing networks.
Robert Di Scipio is president and CEO of Aegis Analytical Corp., which licenses its Process Intelligence software platform to manufacturers of biotech, pharma, and chemical products.