Biosimilar Development

UGA Biopharma offers stable mammalian cell line development for high-titer and scalable manufacturing of various molecules (e.g., IgG1, IgG2, IgG4 and non-antibody proteins). We have optional access to different CHO cell lines and optimized vector systems for transfection. Depending on the customer┬┤s requirements, cell lines are chosen to provide the cell line that is best suited for the subsequent workflow. The selection of the best suited CHO host/vector system is absolutely critical for the success of the project and significantly impacts all downstream workflow steps, as well as the quality of the manufactured research cell bank.

UGA Biopharma┬┤s contract development of product-expressing CHO cell lines -- used for the manufacture of biosimilars -- is a full service that starts with the acquisition of the originator molecule and analytical characterization and continues through final release QC:


Start with acquisition and analytical characterization of the reference drug (originator) to ensure highest biosimilarities in subsequent cell line development

Determine amino acid sequence to ensure sequence identity between biosmilar and reference drug

Construct synthetic gene 

The originator molecule is also used as reference for method development in DSP and analytics.

Cell Line Development

With our optimized workflow, the entire cell-line-development service can be executed within 7 months. A full UGA project consists of the following:

Cloning of gene of interest into optimized vector systems

Transfection of selected CHO host cell line(s) using stable transfection protocols; the number of host cell lines determined by the project budget

Transient-expression evaluation at pool level and selection of most suitable host cell line

Pool generation with the most suitable host cell line

Single-cell cloning and selection of high-titer and high-similarity clones

Characterization within various fed-batch processes (e.g., media and feed screening)

Expression-stability screening

Generation of a tested research cell bank (RCB)

Our workflow ensures fully traceable origin and history of clones generation and documents.


Upstream Process Development

To generate quality profiles that are highly similar to the originator drug, we fine-tune similarity and enhance cell productivity by developing extended upstream processing (USP). This processing includes the following:

Culture-process optimization at lab scale (250 ml)

Scale-up of optimized culture process to 5 liters

Proof of consistency confirmed with two identical runs at the 5-liter scale

In addition, top clones are selected based on behavior under stirred-tank reactor conditions. This work strategy ensures the successful generation of high-quality biosimilar-producing research cell banks.


Downstream Process Development

UGA`s downstream processing (DSP) department develops efficient strategies for the purification and recovery of biopharmaceuticals from cell-culture supernatants for the assessment of quantity, purity, potency and biosimilarity. Host-cell protein, leached protein A, residual cell DNA and protein aggregates must be removed. The purified protein should have physicochemical properties that are similar to the originator molecule. Developed purification protocols can be transferred to the customer.

Development of DSP purification procedure (for analytics) in parallel to cell line development

Optimization of a capture step followed by polishing steps

Adjustment of charge-variants profile

Extended fine-tuning of biosimilarity, depending on project budget


Analytical Method Development

UGA┬┤s analytical department develops methods to estimate product titer and to characterize the product┬┤s physicochemical properties. The role of analytics is crucial, as the results of sample analysis will aid cell line development and upstream and downstream processing to select a CHO host/vector system. Analytics also optimizes cell-culture-medium components and identifies optimal conditions for bioreactor and purification runs.

Development of standard analytical methods, e.g.:

                       Protein A HPLC for titer estimation of IgGs
Size-exclusion HPLC
Charge-variants profiling
N-glycans and sialic acid profiling
Peptide mapping

Further methods available through external partners



After selection of a suitable biosimilar-expressing single clone and stability study, the final release includes analytical characterization, sterility and microbial load testing. Final vials containing the selected cell line as well as the development report are shipped to the customer.

Contact us!

UGA Biopharma GmbH
16761 Hennigsdorf, Neuendorfstra├če 20a (Germany)
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Phone: +49 (0)3302 / 2024900

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