The reliance on CDMOs by emerging companies and global giants is growing significantly. It is estimated that approximately 40% of all drugs are now made by external partners.1
Traditional challenges like capacity, margins, yield and capital requirements have been supplemented by new issues such as the explosion of personal medicine, the need for rapid scale up and regulatory demands for data integrity and transparency.
Top data-related industry challenges today:
- Disparate internal and external IT and data management systems
- Data stored in non-electronic systems (e.g. paper records)
- Increased complexity in global supply chains
- Compliance in a new era of regulatory scrutiny (FDA & SEC)
- Process complexity of new therapies
Some CDMOs are beginning to realize the added value of overcoming these challenges and the benefits of sharing this manufacturing and quality data with their sponsors.
1. PBOA 2018 Annual Conference
Why are tech transfers and data transparency so important?
Historically, with less complex processes and products, information transfers between a sponsor and CDMO were simpler and less frequent. Today, the amount of data generated and collected has increased exponentially and is captured earlier on in the product lifecycle. Additionally, good business practices and regulatory mandates require seamless, reliable data transparency throughout process development, tech transfer and manufacturing.
Establishing a “single source of data truth” early on in product development and building & maintaining that knowledge throughout the product lifecycle is the goal. It enables compliance for sponsors and CDMOs and provides a consistent end-to-end customer experience.
Overcoming Fragmentation: Disparate data and IT systems
Managing disparate data types: continuous, discrete, replicate and, of course, paper, has always been a challenge – even within captive manufacturing operations. The first challenge is to aggregate data from various proprietary systems and then to add the critical paper data (related to development or batch data).
A second hurdle is to retain or provide the appropriate context so that the data can be relied upon and analyzed to create the required quality, production and regulatory reports. All of these steps are complicated by the fact that data is often generated in multiple sites, at different companies with various IT levels of automation.
Small drug companies and CDMOs often have less complex IT systems but most of the industry still has vast amounts of critical data on paper which makes access difficult for cross-functional teams.
Innovative CDMOs are are looking to modern IT technology to unlock the value of their data
In addition to the disparate nature of data collected, there remains significant differences in the state-of-the-art in CDMO data sharing. Historically, some CDMOs viewed their scaleup and manufacturing expertise as something to be protected and that often meant the associated data generated as well. Therefore, many reports back to sponsors contained only summary data, not all the in-process parameters and CQAs. Additionally, due to lack of time and resources, these reports were generally sent in PDF form, making it difficult for sponsors to be able to reuse and analyze their data.
As sponsor expectations increase, many CDMOs are trying to share data more widely but are limited by their existing technology and reliance on paper records.
The most innovative CDMOs are recognizing that data integrity and data transparency are not only regulatory obligations – but are also good practices and they are working with sponsors to implement new data sharing technologies that generate immediate business value for both parties.
What do these new technologies look like? How will they address the barriers created by fragmented systems and manual processes? How can this added value be harnessed?
