There’s no question that today’s life sciences landscape is changing dramatically. As new personalized medicine solutions emerge, companies are rapidly changing scale to include more multi-product manufacturing facilities. Many of these facilities are manufacturing treatments in much smaller batches.
While many of the requirements around developing smaller-batch treatments are the same, the market does have its own unique challenges. In her recent article in Pharma Manufacturing magazine, Michalle Adkins explores these challenges, and shares some of the ways enabling technologies can help meet the small batch industry’s unique needs.
More batches, more complexity
As Michalle explains, the number of batches in the small batch world is typically higher, and that increased number of batches generates a lot of additional data. She shares,
“Capturing the knowledge about a product and defining the associated process is necessary for licensing. Yet, that same knowledge is also useful for developing new products with similar unit operations, or on the same platform, to share learnings from successes and failures, for transferring knowledge to support multiple manufacturing locations and for managing the lifecycle of the product (e.g., continued process verification, assessing deviations, evaluating potential changes, etc.). In the small batch world, these needs are intensified.”
One of the key tools for capturing knowledge with context and preserving it across the complex technology transfer process is process knowledge management software (PKM). PKM software breaks down the silos of unstructured data that complicate the technology transfer process. Instead of spending time reconciling different terminology, equipment, and data structures between all the groups involved in research and development and manufacturing, PKM software stores and standardizes all data in a digital central repository to facilitate collaboration.
With fast and easy access to all data from across the development pipeline via an intuitive, web-based application, change management is simplified and manual data entry errors are eliminated. Moreover, PKM helps enforce GMP compliance and change management across the entire recipe lifecycle.
Eliminating dangerous mix-ups
As more batches of different product types are produced in a facility at the same time, it becomes even more critical to track details about the individual batches. Michalle explains,
“In the cases where a specific batch is designated for an individual, such as in CAR-T cell therapy, it is important to ensure that the operator is working on the right batch and documenting actions in the corresponding record. In this case, the chain of identity tracking throughout the entire manufacturing process must be maintained. Also, with many small batches come many batch records to be managed.”
One of the key technologies being implemented to navigate this complexity is real-time dynamic scheduling software in conjunction with electronic records and manufacturing execution systems or electronic workflow solutions. Such a system helps teams track the progress of every process step and identify how changes will ripple throughout the process. Working together, these systems can also provide
“confirmation steps that the batch under manipulation (e.g., sampling, testing, feeding, harvesting, storing, retrieving, preparing for shipping, etc.) corresponds to the correct record with the right chain of identity reference, whether the recording process is paper batch records or electronic batch records, or a combination of paper and electronic recording processes.”
Michalle explores a number of other technologies and shares some specific real-world examples of how they are shaping the industry in the full article at Pharma Manufacturing.
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