New Technology on Multiplex ADA Isotyping
Dan Barry:
Welcome to this podcast from the Cambridge health check institute for the 2017 Peg Summit running from the 1st to the 5th of May in Boston Massachusets. I'm Daniel Barry, a senior conference director at CHI, and with us today we have a key speaker from the strategies for immunogenicity assessment conference, Dr. Shuanping Shi, director biologic for vaccine biolistics at Merck Research Laboratories. Dr. Shi, thank you very much for joining us today.
Shuanping Shi:
Thank you Dan.
Dan Barry:
Dr. Shi, please tell us a little about your role at Merck, and the department that you lead.
Shuanping Shi:
So I lead active development and validation and new technology in Merck about vaccines, about analytics. So, we support scientific studies where for the [inaudible 00:00:43] studies or clinical studies, we will support analysis of drug levels even in genitives or [inaudible 00:00:51] engagement in those subjects.
Dan Barry:
And your presentation focuses on new technology on multiplex ADAs iso typing. What are the current challenges in this area, and how does your presentation aim to address these issues.
Shuanping Shi:
I think the challenge in the ADA, one is that there are many ADA iso types that we need to monitor so it has a [inaudible 00:01:13] issues and also there's a sensitivity issue, for example the most critical isotope, iso type IGE is always at a very low concentration so our work is to focus on the developing a multiplex approach, which means that in one reaction, we're looking at many different iso types in the same reaction, for this way, we are saving samples, or using one sample, but we're looking at multiple ADAs; IGG, IGE, IGM all that, and this hopefully will increase [inaudible 00:01:45] and efficiency. And so we're looking a couple new technologies for this multiplexing approach.
Dan Barry:
Could you tell us a little about how your approach differs from other companies?
Shuanping Shi:
Others, and previously were looking at iso typing of each iso type one by one, so for each iso type, like IGG 1, 2, 3, 4, will need 4 different samples to analyze or categorize the iso type. So with the new approach, with just one sample, with one reaction, we can characterize all 4 different iso types. Same holds true for different iso types like IGE, IGM, IGA, will include everything in that one reaction.
Dan Barry:
And is there kind of estimation on the terms of the efficiency is?
Shuanping Shi:
Yes, it will help with efficiency and includes [inaudible 00:02:32] and also safe samples. Remember when we get samples from patients, we got a limited amount, and we need to use that ADA detection and we need to use that for iso type [inaudible 00:02:45]. So say the sample is always good.
Dan Barry
As well as your presentation, I have lots of community related topics onto the stream. I just want to get your thoughts on general either technology or information gaps that you believe that exists in the area of immunity assessment.
Shuanping Shi:
Yes, in terms of immunity necessity testing, the gap I see is, first of sensitivity, as I mentioned, if you are interested to look at IGE, usually IGE is in a low concentration, so how would you include the sensitivity of your acid to detect that iso type and also, another gap I see is now there are many combinations studies. So, patients that treated with more than one biologic, so how would you detect [inaudible 00:03:29] necessities for each bio logs and to avoid interference between the bio logs. And the other one is a positive control, as we all know, your acid is as good as your positive control, so traditionally people would use antiserum from an animal, you inject animal with your drug, to generate antiserum, and you use that poly clone antibody as your positive control for your ADA acid. However, that doesn't really represent a true ADA population in patient. So how do we get a more representative ADA positive control. So what I have is, can we use let's say a way to display library. Like screen the human antibody library using your drug and to fish out the human antibody against the drug, does that represent the ADA population in patients better? Or can we use serum from the dosed patient as the positive control, so there are many possibilities.
Dan Barry:
I just really want to kind of get your thoughts on some of the other sessions, either within the miniature c track, or some of the other sessions taking place at the next conference as a whole. Any particularly interested suggestions that you are going to be attending?
Shuanping Shi:
Yes, I am particularly interested in two sessions, one is the market domain products, immunogenicity for market domain products. I think nowadays people are developing specific antibodies and this is very interesting, and the other one is affect of ADA on PK acids. So I think this is particularly interesting, because usually when people develop PK acids, it's hard to value how patient ADA would interfere with your PK acid, so I really want to see how colleagues from other companies address this question.
Dan Barry:
Well Dr. Shi, thank you very much for your time today, for sharing your thoughts on today's podcast, it's been great speaking with you.
Shuanping Shi:
Thank you it's my pleasure.
Dan Barry:
That was Dr. Shuanping Shi, director of biologics vaccines file analytics at Merck Research Laboratories, she'll be speaking at immunogenicity assessment conference at the upcoming Peg's meeting in Boston. For more information about the meeting, please visit pegsummit.com. I'm Daniel Barry and thanks so much for listening.