Poster
Faster IND Starts with Better Cell Lines
Reaching IND Faster with Accelerated & High-Yielding
Cell Line Development
Abstract
Biopharmaceuticals such as monoclonal antibodies (mAbs), bispecific antibodies (bsAbs) and therapeutic proteins represent a rapidly expanding
category of drugs offering new clinical applications. Achieving maximum production of these molecules is dependent on many factors such
as suitable host cells, optimal expression vectors and culture conditions.
Here, we show ProBio’s Cell Line Development platform allowing high productivity and purity for biologics production through proprietary CHO-K1
cell lines, pGenHT 1.0-UPvector, and UproCHO culture media. Our platform achieves rapid production of average titer 7.53 g/L (mAb) and maximum
15.23 g/L (mAb) within 7 weeks from transfection to PCB construction.
In summary, ProBio has established superior CLD platform guaranteeing the accelerated and high-yield cell line development to propel faster CMC.
Workflow of ProBio’s Cell Line Development
ProBio’s Cell Line Development Platform
Proprietary Host Cells
Proprietary Expression Vector
Proprietary Culture Media
Wild-type from ECACC
Suspension-adapted
Proprietary UproCHO basal, feed
media & perfusion media developed for
ProBio CHOK1-GenS
pGenHT 1.0-UP
Glutamine synthetase (GS)
system
Animal product-free culturing
Optimized cell growth, productivity and
product quality
“TiterUp” enhancer element
Traceable records & thorough
QC & sequence confirmation
Afucosylated antibody production
Lower Man5 proportion than other major
media brands
Affinity to Fcγ Receptor (CD16a)
High Productivity
Two-vector transfection system
For the development of bsAb/multi-spe-
cific antibodies, expression in a single vector
leads to multiple by-products, decreasing
the productivity.
Expression using two vectors and adjusting
the transfection ratio significantly increases
the titer and minimizes mismatch.
Reducing impurities and mispairing at
the early stage shifts the paradigm from
downstream removal to upstream prevention,
enabling simpler purification, lower costs,
and inherently higher product quality.
Homodimer ↓
Excellent stability in 60-90 PDLs
Traceable record for host cell, vectors
and cell line development
Heterodimer ↑
Productivity ↑
Purity ↑
Monoclonality verification by Cell Metric®
ADCC Enhanced Cell Line Development
Extensive Experience in
Complex Molecules
Excellent productivity and stability enables
process scale-up.
The titer was ~6g/L before process
development and reached 8g/L after
process development.
Cell growth performances of CHOK1-ADCC+
in 3L stage and in 150L stage are consistent.
The key quality attributes showed stable in
the process scale up from 3L to 150L.
*ADCC activity is measured by reporter gene assay, with acceptance between 70%-140%
ProBioCDMO.com