“Evidentic drug aliquots have significantly reduced our development cycle time and strengthened our ability to do detailed [protein] characterization”

Dr-Stephan-Schultz

Dr Stephan Schultz, Team Leader of Analytics/DSP at UGA Biopharma GmbH

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UGA Biopharma GmbH is a contract research organization that develops Chinese hamster ovary (CHO) cell lines. These cells express biologics and biosimilars, including those used in upstream and downstream strategies. Their comprehensive cell line development platform delivers high titers of 4 to 7 g/L, with short timelines of 3 to 4 months. They also offer chemically defined, high-performance, First CHOice® media and feeds to boost biopharmaceutical production, and ready-to-use biosimilar cell lines for GMP manufacturing. This narrative is the result of the May 8th, 2020 interview with Dr. Schultz. The content has been edited for clarity.

What makes multiple batches of drugs an essential part of biosimilar development?

Developing cell lines that produce a protein of interest is one of the first steps in biosimilar development. The protein of interest is extensively characterized and matched with the reference drug to identify the critical quality attributes (CQA, ICHQ8) such as aggregation state and N-glycan profile. These product attributes can only be obtained by testing different batches of the reference drug.

What’s the problem in obtaining multiple drug batches?

Sourcing enough drug batches with varied expiration dates is a limiting step, which adds months to biosimilar development schedules, because: 

  • When only a few batches are released every year, it is difficult to find 10 or more batches of target materials, especially batches with different expiration dates. 
  • Finding historic batches (in which the expiration date has passed) is almost impossible. Neverthelessthese batches are essential to testing the effect of expiration dates on drug products. 
  • When we buy a drug from a pharmacy or other sourceit is available as a single pack that might contain 100 mg or more. Because we often need only 5 mg per batch, buying a whole pack is a massive waste of time and money. 

How did Evidentic help you solve these challenges?

The unique Evidentic value proposition provided UGA with:

  • A library of multiple drug batches, including historic batches with different expiration dates.
  • Rapid access to desired quantities of drug in the form of drug aliquots (small-volume samples of a larger batch of drug).
  • Services, which included reasonable prices, fast delivery, and easy, effective communications.

How did Evidentic services help your development process?

The need to find batches with different expiration dates increases project cycle times. Evidentic drug aliquots have significantly shortened the time we need to do detailed characterization, which gives our clients a competitive advantage.

Can you recall an experience that focuses on batch-to-batch variation?

From Evidentic, we obtained four batches of daratumumab aliquots from the reference drug, Darzalex®. We compared the N-glycan profiles of each batch, which showed a very narrow range of variation. This narrow range helped us to rapidly optimize our cell line for the defined N-glycan product profile, an important part of our quality assurance process.