Technical development

Innovative technologies setting the foundations for our biosimilar development

Our cell line development, process development and analytical development team set the foundation for all our programs. They are the first step in creating our biosimilar pipeline.

The Pathway CHO-K1 cell line

Stable, scalable and highly productive

The first step in creating our biosimilars is establishing a stable cell line expressing the biosimilar of choice. For this we use our proprietary CHO-K1 based cell line which has a proven track record on titer, stability and scalability ensuring a smooth route through process development and manufacturing.

The cell line has been used to produce over 50 therapeutic biologics with many going onto clinical trials.

The Simple cell line delivers high titers for almost all types of proteins. We consistently deliver titers from 4-9 g/l. Even for difficult to express proteins.

Simple Cell Line™ can express:

mAbs
recombinant proteins
fusion proteins
bispecifics
biosimilars
antibody fragement
among other biologics format

Graph showing high titers from Pathway Cell Line Development for antibodies and proteins

Our cell line has an excellent track record of scalability and stability and has been used to produce clinical material in 2000 L bioreactors. It is based in the CHO-K1 cell line, which has been used to produce for hundreds of biologics globally.

Stable, repeatable and highly viable process

The graph to the right shows how Pathway CHO cell viability over 14 days in 2x3, 2x10 L STR. The cell line has been run in 2000 L bioreactors with proven scalability and can be used for pre-clinical, clinical or commercial production.

Graph showing stable and scalable cell lines

Our timeline allows for the production of pre-clinical material and start of process development, if desired, from 3 weeks.

We utilize the latest equipment throughout the process including:

Ambr15 - an automated high throughput mini bioreactor system
Cellavista - an Ultra high throughput imaging system
Cytomine - single cell analysis to ensure proof of monoclonality
Octet - allows rapid titer measurements

Combined this allows us to screen upto 2000 clones a day

Timeline for Pathway Cell Line Development for creation of a monoclonal RCB

Bioassays

We have also developed a toolbox of bioassays especially designed for comparing biosimilar activity to originators. These include:

Binding
Cell based assays
Membrane bound antigen binding
Classical ADDC assays
CDC assays

Analytics & bioassays for biosimilars

We have an extensive analytical and bioassay toolbox that ensures biosimilarity, including in-depth analysis of post-translational modifications to match them to the originator. We also have access to a wide range of originator drugs to allow comparisons.

Process development for Biosimilars

Creating scalable upstream and downstream processes. Our biosimilar process development focuses on quality and reducing cost. We know that it is critical to reduce overall cost of goods and the way we design our processes increases titer without increasing media and feed requirements.

We carefully monitor all our process changes with our enhanced bioanalytical capabilities to ensure we don’t affect biosimilarity.

For upstream development we run multiparametric experiments in parallel using ambr® high-throughput systems to optimize media and culture conditions for scalability. For our downstream process development we leverage a panel of state-of-the-art separation technologies and follow DoE principles to achieve maximum recovery and purity of target proteins.

The required process characterization is performed based on qualified scale-down models and is supported by high-throughput analytical instrumentation.

Let’s collaborate and deliver quality biosimilars together.

Get in touch for more information.