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 INTERSECTIONAt 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 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.