Determining Process Quality Metrics for CMOs - Implementing quality by design makes the determination of quality metrics across CMOs and sponsors essential. - BioPharm International

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Determining Process Quality Metrics for CMOs
Implementing quality by design makes the determination of quality metrics across CMOs and sponsors essential.


BioPharm International
Volume 25, Issue 6, pp. 14-19

The bio/pharmaceutical industry is witnessing two important manufacturing trends. First is the increasing adoption of quality-by-design (QbD) approaches to enhance process understanding, which results in a long list of consumer, regulatory, and business benefits. The second trend is the increased use of contract manufacturing organizations (CMOs) to better manage plant capacity and control production volumes.

According to the 2012 BioPlan Associates' 9th Annual Report and Survey of Biomanufacturing, "Relatively few companies have outsourced all of their manufacturing, but nearly one-half of surveyed manufacturers expect to increase their budgets for biopharmaceutical CMO outsourcing (in 2012)" (1). As relationships with CMO relationships increase and expand, and QbD becomes more essential to business strategy, it is important to examine best practices for determining quality metrics across CMO and sponsor networks.

A CHALLENGING INTERSECTION

At the intersection of QbD and CMOs is the challenge for sponsor organizations, who have invested time, technology, and resources into QbD programs for their own manufacturing sites, to ensure that products manufactured by CMOs meet similar quality expectations for safety and efficacy. With QbD in mind, many biopharmaceutical manufacturing teams have integrated process intelligence technology tools and practices into their working approaches to collaborate across company-owned (or captive) global sites. Such tools can help teams access large amounts of process data stored in disparate systems (e.g., laboratory information management systems, enterprise resource planning systems, manufacturing execution systems, and records stored in paper formats) for proactive process monitoring and investigative analysis.

As part of the QbD process, many sponsors have developed sets of critical process parameters (CPPs) and key performance indicators (KPIs) to routinely monitor processes and increase inhouse process understanding. When it comes to outsourcing, sponsor companies desire a similar level of monitoring and understanding from their CMO partners.

The complexities of data sharing across sponsors and third party CMOs—many of which may be geographically dispersed—include the following challenges:

  • Sponsors and CMOs have different operational models and, therefore, different interests when it comes to data. Sponsors are looking for quality assurance of the product, while CMOs most often use process data to compare one batch with another at a local level. The manufacturing processes of CMOs can also vary greatly between plants, which means that direct site-to-site data comparisons may not be appropriate.
  • Most existing sponsor–CMO contracts do not fully specify which data must be shared, or what mechanism should be used for sharing it. In addition, contracts often do not incorporate enough flexibility to take advantage of improvements in process or data sharing technologies that may become available during the life of the agreement. Data sharing is usually limited to release data for regulatory requirements, and does not include data that are comprehensive enough for the proactive monitoring and investigational analysis required for QbD and continuous process verification. In addition, CMOs tend to produce products for several customers and can be cautions when it comes to allowing sponsors to tap into existing IT systems to retrieve data.
  • CMO records are frequently stored and communicated to sponsors as paper-based documents, making access and analysis difficult.

Sponsors need to collaborate with CMOs to develop monitoring programs that assist in process understanding and verification at CMO sites, similar to the programs sponsors have developed for use across their own global manufacturing networks.


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