By Delara Motlagh, General Manager, Cell Therapy Technologies, Terumo Blood and Cell Technologies
For every enterprise serving the pharma sector, including providers of emerging advanced therapy
medicinal products (ATMPs), the highest quality standards are a patient safety priority. Because the
therapeutic process starts and ends with the individual patient for autologous therapies, product
delivery depends on several critical steps ending with a sterile fill and finish process.
No room for manual fill and finish risk
Although pharma has learned to refine and control the manual processes associated with fill and
finish, such methods are proving cumbersome and carry increased risk because they are prone to
human error.
Manual processes, especially in autologous therapies, can introduce variables that are hard to
identify, let alone control. These variables can compromise quality and interrupt the therapeutic
value chain, which can cause frustrating delays in delivering a finished product where it's needed
most: to the patient.
Automating both processes and data acquisition can help: in fact, the industry agrees that
automating ATMP processing steps is the best strategy for reducing manufacturing risks and
ensuring compliance. Pharma Manufacturing's Smart Pharma Survey, which separately polls drug
manufacturers and equipment and services vendors, reports rising confidence. In the latest survey,
93% of manufacturers and 87% of vendors believed pharma has become more comfortable with
automation.1
Similarly, automating data acquisition across key manufacturing, maintenance and compliance
processes can also help optimize quality control and quality systems management, as we explore
below.
Automated data acquisition: A key quality and compliance attribute
Each step in the delivery of a cell or gene therapy represents a discrete production or processing
event. Delivering personalized therapies across the continuum of care creates a complex current
Good Manufacturing Practices (cGMP) environment that is challenging to both validate and develop
adequately to withstand ongoing regulatory scrutiny.
Poorly organized data, which can stem from manual steps, and error-prone systems can greatly
affect quality and compliance risk. Fortunately, automated systems like the FINIA® Fill and Finish
System make it much easier to efficiently acquire meaningful, accurate data at each step and
leverage it intelligently.
Finia is an automated system from Terumo Blood and Cell Technologies that formulates and aliquots
fluids, including cell suspensions, and prepares them for cryopreservation. Why is automated data
acquisition from that process so critical to fill and finish quality? Here are three top reasons:
1. Ensures data integrity
Without a way to demonstrate to regulators that the data recorded is accurate, maintaining cGMP
compliance becomes very tough. A validated, integrated information system that automates data
acquisition, as Finia does, ensures data integrity by eliminating human error and gaps in process data
streams.
The data integrity inherent to automated acquisition ensures the quality of all further product
outcomes, while promoting cGMP for proactive regulatory compliance and patient safety.
2. Reduces product variability and error
Automated fill and finish systems can generate an abundance of high-quality data that the
organization can leverage to reduce product and process variability batch-to-batch and across
operators and operations. They can also document process- or operator-induced errors, which helps
with corrective and preventive action (CAPA) efforts and quality systems management (QSM)
operations.
Automating the collection of patient and product-in-process data can also help operations track and
identify critical quality attributes (CQAs) and control variability more accurately at each step in an
autologous therapeutic process.
3. Facilitates efficient cGMP data and reporting compliance
Automated data acquisition makes compliance reporting a more straightforward and economic
digital process. A well-engineered software solution helps facilitate cGMP data and reporting
operations and compliance across the continuum of care.
For example, Terumo Blood and Cell Technologies offers its Cell Processing Application (CPA) with
Finia to automate information-based tasks associated with fill and finish. Procedure data, for
example, can be automatically transmitted between the system and the application while the
system is operating.
Operators can use the application to be more efficient and accurate at:- Assigning permissions
- Tracking tubing sets and materials
- Recording alarms
- Capturing electronic data reliably
- Generating batch, procedure and compliance reports
Automate data acquisition for best results
Finia data automation facilitates cGMP compliance and product quality by giving users access to
accurate, high-fidelity data to optimize processes and operations. Finia helps with the overall process
compliance through:
- User authentication
- Data capture and reporting
- Workflow configuration and control
When its data acquisition and management abilities are integrated into operations, a fill and finish based
solution like Finia helps deliver high performing-treatments.