Cell Line Development for Biosimilars

Polpharma Biologics have over 25 years of success in generating high-yield production cell lines for biosimilars. We take a different approach to other companies as we focus on delivering high titer cell lines and then tailoring modulation to match the given quality target product profile. This means you get biosimilarity without having to forgo high expression, significantly reducing upstream and downstream costs.

Developing high quality, high titer biosimilar cell lines with CHO^BC®

Our proprietary CHO^BC® expression platform allows rapid generation of high-quality cell lines with a completely animal component-free (ACF) process. High-throughput technologies are deployed to increase productivity and achieve the highest titers possible, while minimizing undesired species and achieving fingerprint-like biosimilarity.

Our CHO^BC® expression platform combines the following features:

CHO-K1 derived suspension cell line
Allows rapid generation of high-quality cell lines
Completely animal component-free (ACF) process
Grown in chemically defined media
High-throughput technologies deployed to increase productivity, achieve highest titers possible, minimize undesired species
Research cell banks are rigorously tested for the absence of viral elements in accordance with ICH guidelines.
CHO^BC® cell lines have already been successfully scaled-up to 1,000 L and used to produce drug substance for clinical trial supply
Competitive timelines from DNA to research cell bank
Quick scale up to 50 L for pre-clinical supply
Combine with our master cell banking, process development and manufacturing services for a fast route to IND

SLIM™ technology improves process efficiency and allows for further process optimization

Our Scientific Leverage of Innovative Metabolism (SLIM™) technology reduces feed consumption at much lower power input eliminating hardware limitations in upstream development, reducing the cost of development.

Enhance expression with SPOT™ technology to deliver up to 9 g/L

Our CHO^BC® cell line delivers good tires as standard from 2-4 g/l but we have developed our Specific Productivity Optimization Technology (SPOT™) which increases the specific productivity of the desired protein without increasing the amount of host cell protein or other undesired excipients. This significantly reduces downstream costs due to easier purification.

titer (g/L)

250%

150%

190%

180%

570%

biosimilar 1

SPOT™ biosimilar 1

biosimilar 2

SPOT™ biosimilar 2

biosimilar 3

SPOT™ biosimilar 3

biosimilar 4

SPOT™ biosimilar 4

SPOT™ + SLIM™ biosimilar 4

biosimilar 5

SPOT™ biosimilar 5

SPOT™ + SLIM™ biosimilar 5

biosimilar 6

SPOT™ biosimilar 6

Productivity increases seen once SPOT™ technology has been applied to CHO^BC® cell lines. Titer increases from 150 to 300% are regularly observed.

Tailoring modulation to match PQA

We have industry leading expertise in modifying glycosylation patterns during upstream development which have a significant effect on ADCC, half-life, stability and immunogenicity. In addition, we are able to use our process modulation tools to steer the charge profiles to meet originator profiles. We use our detailed understanding of interplay between intracellular enzymes to modify the building of these units so they match the patterns of the originator without affecting productivity. We can tailor:

N-glycan peaks
Sialic acid
Fucosylation
Mannosylation
Galactosylation
HCP content
Acidic species
Basic species

Access to originators

Having good access to originator biologics is critical for the development of biosimilars. It is also critical you have multiple lots and batches of the originator from different sources to compare from. That’s why we have a team dedicated to procure originators from both European and US sources for every project to ensure confidence in biosimilarity.

Accessing CHO^BC®, SLIM™, SPOT™ and our modulation technology and expertise

Polpharma Biologics offer their cell line development packages on a fee for service basis, this can either be as a stand alone cell line development project or as part of an integrated cell line development to IND package.

We can also work on improving your current cell lines productivity with our SLIM™ or SPOT™ technology and or tailor modulation to match PQA.