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. Nevertheless, these batches are essential to testing the effect of expiration dates on drug products.
• When we buy a drug from a pharmacy or other source, it 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.