Cell-based therapies offer new hope for patients with unmet medical needs. Yet, their short shelf life and combined with the lag of traditional quality control methods can pose serious safety risks.
The need for rapid, reliable QC solutions has never been more urgent. This infographic explores a real-time PCR-based approach that delivers sterility test results within three hours. It also highlights innovations that reduce handling, minimize false negatives and detect over 95% of known bacterial contaminants.
Download this infographic to explore:
- How real-time PCR enables QC within the narrow treatment window
- Key methods for cutting analysis time and improving efficiency
- Solutions that minimize false negatives and ensure critical contaminant detection
Cell-Based Therapies:
Be on the Safe Side
Challenge:
Advanced therapy medicinal products (ATMPs) are driving dramatic improvements in the outcomes of patients
with major, previously unmet medical needs. Yet, the short shelf life of ATMPs and long duration of conventional
growth-based QC release are out of sync, creating a need for rapid tests that enable healthcare professionals to
know a product is free from contaminants prior to treatment.
The result is healthcare professionals only learn if a cell-based therapy is contaminated days after
administering it, forcing them to put patient safety at risk every time they administer an ATMP.
Delivering Rapid Results
Solution:
Healthcare professionals no longer need to expose patients to those risks. Equipped with realtime polymerase
chain reaction (PCR) kits, manufacturers can validate the quality of ATMPs within the narrow window of time
in which such therapies are viable for use.
Microsart® ATMP Sterile Release kits for the detection of mycoplasma, bacteria, fungi and Mycoplasma
kits are quantitative PCR tests developed by Sartorius to meet the specific, demanding requirements of
manufacturers of cell-based therapies.
Improving Testing Efficiency
Solution:
The nature of ATMPs means testing speed is critical. However, speed cannot come at the expense of accuracy.
False negatives are as dangerous as the late detection of contaminants as they lead to the administration of
potentially harmful ATMPs.
Recognizing that, Sartorius has taken a multiplex PCR approach to enable the generation of results for sample
and inhibition control from a single well. The approach minimizes false negatives. Equally, the approach cuts
handling and analysis by 75% by generating as much data from 12 tubes as other vendors gather from 48 tubes.
Detecting Critical Contaminants
Solution:
The final requirement for an effective ATMP QC release test is breadth. A test could be quick and have a
workflow that increases laboratory efficiency but still puts patients at risk because it is unable to detect
potentially dangerous contaminants.
Microsart® ATMP Bacteria detects
more than 95% of known bacteria,
as evidenced by tests run by Sartorius.
The kit specifically and accurately detects critical cell therapy contaminants that can be missed by classical
sterility tests. Sartorius validated the sensitivity of its kit in studies that looked for 12 critical cell therapy
contaminants, plus other selected species of bacteria.
A New, Safer Era of ATMP
The combination of speed, accuracy and efficiency provided
by the Microsart® ATMP Sterile Release kits means ATMP
manufacturers can deliver QC results prior to treatment. In
doing so, the industry stands to eliminate one of the outstanding
risks to patients posed by ATMP, thereby setting the stage for
the use of consistently safe lifesaving cell-based therapies.
The tests deliver QC results within three hours. That represents a time savings of more than 90% over
growth-based QC release. In the context of treatment with an ATMP, the time savings could be the difference
between administering a contaminated product that harms the patient and delivering an untainted therapy
that saves their life.
With Microsart® ATMP Sterile Release kits, the cell-based therapy sector has the means to provide QC results
prior to treatment, thereby eliminating a threat to patient safety.
ATMP
ready-to-use
ATMP: short-shelf life (e.g. 48h)
14 28
Rapid sterility
testing
QC-release
for sterility
QC-release for
Mycoplasma-control
Treatment
Days
Rapid QC-results:
Mycoplasma release according to EP
Bacteria pre-check
Fungi pre-check
QC-release according to
current guideline landscape
0 1 2 5
ATMP
ready-to-use
0
ATMP: short-shelf life (e.g. 48h)
2 5 14 28
Rapid sterility
testing
QC-release
for sterility
QC-release for
Mycoplasma-control
Treatment
Days
Many cell-based
therapies, a form of
ATMP, need to be
used within two days.
Other tests take far longer.
QC release for sterility based
on traditional compendial-type
methods for sterility takes 14 days.
QC release for
mycoplasma control
takes 28 days.
However, even
“rapid” sterility
testing takes
five days.
Save 75%
in handling
and
analysis.
Minimize false negatives +
QC results
within 3 hours:
90% time
savings
QC result pending
QC result available
Treatment despite risk:
ATMP might be contaminated.
Treatment with confirmed quality
The patient’s life was put at risk.
“Your prospects for recovery
look promising.”
5 – 28 days later:
QC results available
5 – 28 days later
Sartorius: 12 tubes Vendor B: 48 tubes
Sample reactions
Inhibition controls
> 95%
of known
bacteria
