However, probably the most interesting trend that we see from our more recent polls concerns the implementation of two-tiered reference programs. A two-tiered system consists of a primary (aka gold standard) reference and a secondary (aka working) product reference. The working reference typically comes from the standard manufacturing stream and is qualified against the master reference material. It is used on a daily basis to release product. The primary reference material is that material which comes from the pivotal clinical or engineering batch and is used to qualify secondary (working) references and/or for comparability studies when changing the manufacturing process. Several papers have been published in the past several years extolling the virtues of such a two-tiered reference programs. (See the reference list below).

In 2019, we asked bioassay conferences attendees if they use a two-tier reference system and found that 50% of the audience had only a working reference material – compare this to March 2023 in the US in which 28% stated they only had one-tier systems. Perhaps practices are changing? We will be polling the audience again this year – join us at our upcoming 2023 EUR Bioassay Conference in Bled, Slovenia to find out if this is a trend – or just an example of small sample size statistics

Also at this conference, we will have a half-day workshop dedicated to the topic of late-stage potency assays with a focus on reference material. This in-person attendees only workshop is entitled:

Care and Feeding of a Late-Stage Potency Assay

This two-part workshop covers two critical topics for the debut of late-stage potency assay into a commercial environment: 1) Method transfer and 2) The establishment of potency assay product reference material. Specifically, we will discuss:

Part 1: Assay Transfer

• Assay preparedness for method transfer

• Types of method transfer including covalidation, transfer protocol and other approaches

• Assay monitoring data and the interim system suitability criteria to ease transfer.

Part 2: Reference Material

• Selection of reference material for BLAs and initial years of product approval

• Qualification of reference material

• Requirements for monitoring the reference material

This workshop is presented by Dr. Sian Estdale, Labcorp, Dr. Alex Knorre, Eurofins BioPharma Product Testing, Dr. Laureen Little, Quality Services

This is just one of the workshops from our line-up of over 20 talks and 6 workshops and interest groups. (See the complete agenda HERE). Last year we sold out for the onsite conference, and are on track to have even more attendees this year. Please don’t miss out and register HERE. The podium presentations are available virtually and on-site, however, our workshops and discussion groups are only available to on-site attendees. Don’t miss this opportunity to hear great talks, network with your colleagues and keep up with the industry happenings and trends.