Biosimilars: Reference Drug Aliquots for Faster Selection and Development of CHO-based Production Processes

“Evidentic drug aliquots have helped us speed up our antibody characterization assays and selection of clonal cell lines. An easy and reliable source!”
Prof. (emeritus) Dr. Florian Wurm
Chief Scientific Officer and Founder, ExcellGene SA
ExcellGene is a contract organization for the development and manufacturing of biologics. Specializing in the development of high-yielding (>g/L) production processes and using transient and stable expression in proprietary cell lines CHOExpress™, HEKExpress™ and FlyExpress™, ExcellGene is covering the entire pharmaceutical value chain from DNA construction to a scalable and reproducible manufacturing process for GMP use.

Why do you need to compare samples of commercial drugs during cell line development?

To obtain a biosimilar pharmaceutical, the first step is to develop clonally derived cell lines that express the protein of interest. Once we have a reasonable number of high yield cell populations, we can extract or purify the protein of interest, including recombinant antibodies. With a small amount of purified material, we compare it to the reference biologic that is available on the market. To give an example as to why the comparison with reference material is important, let’s say if one of the clonally derived cell populations would by chance a subpopulation of cells that do not sialysate proteins, we would see this most likely relatively fast: “Okay out of question… the reference material is a much higher sialylated so we better look for other cell lines that come closer to the quality we need.” Thus, reference drugs help us in selecting the right clonal cell lines. We will also do additional work in bioreactors, i.e. modifying process conditions, which pushes the product quality into the range of parameters which are found in reference materials.

How did you obtain samples of commercial drugs before Evidentic?

I remember, it was several years ago, I used to go to the pharmacy and buy it for myself. Sometimes I would need to get a prescription from a doctor and then use it to get the desired drugs. Local hospitals were also a good place to find some left-over material, but only if you had developed a good relationship with the resident pharmacist. Things have changed nowadays and if not for Evidentic it will be very difficult to obtain commercial drugs, especially those which are not widely used yet.

Why do you order reference drugs from Evidentic?

Evidentic provides easy and reliable access to commercial reference drugs, without any hassle of complicated procedures, as with other pharmaceutical sourcing. Evidentic also provides complete documentation with its products, one can put a date, a batch number, and other information together from the drug aliquots. You can then add it to your report, and you have a nice report to share with your clients and you have less doubts on what you are reporting.

Do you have a preference for drug aliquots with a positive or negative therapeutic expiry date?

As a scientist, I don’t care, for me the therapeutic expiry dates are of very little relevance because:

  • Once frozen there are only minor chances for changes in the reference mAb as they are typically rather stable.
  • I know that all the reference drug aliquots at Evidentic are frozen at –80C before their expiry date.

Actually, having a wide range of reference products (with different expiry dates) provides us with a wider range of typical and relevant product characteristics and thus facilitates the complex task to produce a biosimilar. [Reference drugs aliquots from various batches are available from Evidentic]

How did Evidentic’s drug aliquots help your studies and business?

Evidentic helped us save time and hassle involved in procuring reference drugs. As a result, we could shorten timelines and achieve higher client satisfaction. In addition, the availability of samples from batches produced at different production-locations and from different manufacturing campaigns gives us a better understanding of production variations. This, in turn, helps us to ensure the biosimilarity of our product.

Thank you very much, Dr. Wurm, for taking the time for this interview.

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