Executive Q&A topic: Regulatory Requirements for Upstream Bioprocess Solutions
How are regulatory frameworks evolving to address the increasing adoption of bioprocessing in upstream manufacturing?
Bioprocessing is rapidly gaining importance as a path for upstream manufacturing of active pharmaceutical ingredients (API), excipients and other direct ingredients for pharmaceuticals. At the same time novel scientific developments are bringing smaller production scales, processes with very limited downstream capabilities, and customized pharmaceuticals in the game. In any case, the process validation cannot be based on repetitive consistency batches alone. Robust methods need to be found to provide confidence in the process capabilities. In general, the well-established GMP standards are applied for those novel applications as a first step. In parallel, health authorities are working on guidance specifically focusing on the novel applications. This period of unclarity without finalized authority guidelines is a major challenge, as health authorities may reply to market authorization application with unexpected requirements. However, in most instances the common requirements for any kind of device and software regarding data integrity are at least the same. For example, for any contact surface materials the potential contamination sources must be evaluated considering the specific application and downstream capabilities. More precisely defined and better concerted guidelines will hopefully facilitate the procedure of process validation and equipment qualification by the user in the future.
What key regulatory challenges do customers face when scaling from R&D to manufacturing, and how does Eppendorf help address these?
A big challenge for starting scale-up for commercial manufacturing is finding equipment which supports process validation and equipment qualification efforts. For this, documentation by the vendor can help to easily identify the equipment properties and its usability for the planned tasks. Let’s have a look at single-use bioprocess equipment, for example.
Ensured sterility and confirmation of no endotoxins being present are required for any equipment used in biological cultivations. Single-use equipment with the provided documentation reduces the workload for the users and limits shut-down times due to delays caused by the necessity for sterility testing. Moreover, the overall assurance of BSE-TSE-ADI-free conditions is relevant for all cultivation procedures as well. Provided certificates stating either ADI-free or BSE-/TSE-free components support the manufacturing documentation. This also applies for all materials that are not ADI-free but compliant with EMA 410/1 rev.3 and thus using only certified low-risk materials. Single-use systems that are provided as closed systems with documentation proving that there are no materials of concern such as allergens, nitrosamines or substances of very high concern, further reduce the workload for pharmaceutical manufactures as they do not have to prove the compliance for all parts provides complete, uninterrupted data capture, and an alarm history function facilitates deviation management and CAPA (Corrective and Preventive Actions) documentation. Also, PDF reports created by the software can be used for quality management systems (QMS) and regulatory audits. Furthermore, audit trail review and export functions enable inspectors and quality assurance to trace every process step, parameters, and decision that was made. Scheduled backups and time synchronization ensure long-term data integrity and traceability, especially in qualified production systems. All these features are included in our DASware control plus SCADA software to support the user in establishing a consistent documentation for their processes from R&D to commercial manufacturing.
How does Eppendorf support digitalization and AI adoption in bioprocessing workflows?
In today’s world, digitalization and AI are reshaping how we think about science. From smarter decision-making to remote collaboration, the possibilities are exciting. At Eppendorf, we support this transformation with our SCADA software and cloud solutions as they are designed to help control, connect, and advance your bioprocess.
As stated before, with DASware control plus you have a powerful SCADA software that brings all bioprocess equipment together. It captures process data in real time, automates control, and ensures compatibility with regulatory standards. Connected to DASware control is our BioNsight® cloud solution that lets you securely access and visualize your process data from wherever you are. It enables monitoring multiple bioreactors, comparing runs, or checking trends remotely.
The structured and traceable data that result from this software-cloud network make it easier to apply AI or machine learning down the line. One such AI tool is DataHowLab which is cohesively connected to BioNsight cloud as a result of the cooperation of Eppendorf SE and the Swiss company DataHow AG. This seamless software ecosystem enables data transfer from our most recent DASware control software.
Where can people get more information?
Find more information about how Eppendorf can support you on: www.eppendorf.link/commercial-bioprocessing