Scaling analytical capacity while preserving data integrity is essential in biopharmaceutical development as portfolios grow. Transitioning from single- to multi-capillary electrophoresis systems brings challenges such as proving data equivalence, defining robust system suitability criteria and ensuring smooth method transfer between development and QC teams.
This case study outlines a validated approach for implementing high-throughput CE-SDS while maintaining existing SOPs and regulatory compliance across a global organization.
Download this case study to learn:
- How to demonstrate data equivalence between single- and multi-capillary platforms
- System suitability strategies that ensure reliable multi-capillary workflows
- Real-world implementation across formulation, process development and stability programs
Biopharma – protein therapeutics | Analytical Development | PA800 Plus system | BioPhase 8800 system
Case study
Need: The Analytical
Development lab at Teva
required a higher throughput
CE solution to support stability
testing, process development,
formulation, and DOE studies
forBio CMC programs at
Teva Pharmaceuticals.
Challenge: Current SOPs in
pre-commercial programs
utilize the PA 800 Plus system.
All data generated using new
analytical technologies must
produce equivalent data to
ensure data continuity from
Analytical Development to
Quality Control groups.
Goal: Develop a system
suitability assessment
for the BioPhase 8800
system for CGE at Teva
Pharmaceuticals to
demonstrate data equivalence
to the PA 800 Plus system.
Impact: Achieve faster
data collection and higher
throughput while maintaining
existing SOPs, enabling
the reduction of overall
costs and the need for
multiple CE instruments.
Demonstrating equivalence
allows for this method
to potentially be applied
to commercial and precommercial programs alike.
Gaining high throughput without
compromising data quality
Analytical Development R&D CMC Biologics – Teva Pharmaceuticals
Matthew Myers
Associate Director - Analytical Development.
Teva Pharmaceuticals
Current SOPs at Teva for several
programs include the use of the PA
800 Plus system for the reduced
and non-reduced CE-SDS analysis
of antibodies. However, with the
number of samples, and programs
increasing, the throughput in analytical
development needed to increase.
This case study discusses the
considerations when moving from the
PA 800 Plus system to the BioPhase
8800 system in development labs
while ensuring method transfer to
QC labs. It also showcases how the
Teva team plans to implement the
BioPhase 8800 system in development
for clinical phase programs.
Matthew Myers, Catherine Johnsen, Jessica Taylor
The analytical development group at Teva supports sample testing
in formulation and process development and develops methods to
transfer to quality control (QC) for use in clinical and commercial
release labs.
A system suitability assessment
of the BioPhase 8800 system
for Analytical Development
During this phase of development,
thousands of samples need to be
analyzed by capillary electrophoresis
(CE). In 2023, for example, the team
tested over 4000 samples using
CE on the PA 800 Plus system.
Even though the team Analytical
Development sits in development
providing more freedom to operate
utilizing new technologies, they
must consider the transferability
of methods to teams that are in
QC and GMP labs. Demonstrating
data equivalence between requires
systems reduces the need to
perform bridging studies. Pushing more of the middle work:
The BioPhase 8800 system features
8 capillaries compared to the singlecapillary PA 800 Plus system.
Establishing a strategy for how to
treat capillaries is crucial for data
reporting and system suitability. Teva
decided to develop a system suitability
for each individual capillary, treating
each capillary as its own system.
This approach offers several
advantages:
1) Allows for each capillary to have
its own set of controls
2) Allows one capillary to fail, and not
affect the entire data set
3) Accounts for slight differences
between capillaries
4) Accounts for minor errors
in injections
Specific to this evaluation, Capillary
H consistently showed slightly higher
peak area values across all injections
compared to capillaries A to G (Figure
2). The use of one set of system suit
Figure 1 Over 1 year of data results for control standards run on BioPhase 8800 system and
PA 00 Plus system demonstrate an acceptable trend with less than 1% spread
Figure 3 Overall run time of 8 samples displayed in minutes between the PA 800 Plus system and
the BioPhase 8800 system
across all 8 capillaries would have
increased the risk of invalid results for
all capillaries due to this systematic
difference. With the capillaries being
treated as separate systems with
their own set of controls, differences
in raw data can be accommodated
and processed individually, relative to
each capillaries associated control.
Enhancing throughput:
Although not fully exploiting the
throughput of the BioPhase 8800
system, by treating each capillary
individually this effectively provided
the team with one single instrument
that had the capacity of eight PA
800 Plus systems running in parallel
and significantly increased data
acquisition and sample throughput.
The biggest gain the team experienced
was overnight performance, while no
one was in the lab. With the current
SOP for the PA 800 Plus system, 8
samples take over 20 hours to run,
whereas on the BioPhase 8800
system, 8 samples can be run in
less than 7 hours. (figure 3)
