In part one of our introduction to Attentive Science’s new analytical services, we talked about dose formulation services and our chosen in-house technology as well as the benefit it brings to our clients. Every study that is done under the Good Laboratory Practice (GLP) has have dose formulation analysis performed to provide assurance on the test material that is being administered to the test subjects. Through experience and conversation with our clients, we found it was more beneficial to our clients to ensure that this portion of the FDA requirement remains readily accessible to the study director in keeping the project on course.
Generally speaking, there are two main types of therapeutic out there; “small molecule” or “large molecule” (or “biologics”). Small molecule drug development is what everybody has been doing for decades now. In fact, it has essentially become the bread and butter of the pharmaceutical industry. But since 2014, 96 biologics have been approved out of a total of 352 drugs. This is roughly 27% of the total approved drugs by the FDA. In 2021, 50 drugs were authorized, and 10 of those were biologics - including nine peptides, eight monoclonal antibodies, two antibody drug conjugates, and two oligonucleotides that were approved last year.
The process for the biologics is the same as for the small molecules. Attentive can develop a robust and accurate method prior to the study beginning, and perform the dose formulation analysis on the day of sample of formulation preparation. Therefore, the study director and the client will have the results of the dose formulation analysis within 24 hours of the dose preparation. Because the reporting and auditing will all done in-house, we can speak directly with the study director if there is any sort of discrepancy, then rerun samples, and we don't have to wait, potentially leading to an issue where samples might expire.
As an example, recently when running dose formulation analysis, the results seemed to show that two of the dose groups were incorrect. It showed that the results for dose group two were comparable to what should have been three and three should have been two. And because we had those results right away – within a few hours of actually preparing the results - we were able to identify that and make sure that the correct test system was dosed with the correct formulation. It is quite likely that if we had sent that out, those test subjects would've already been dosed with the wrong formulation and then study directors would've had to fix it on the back end instead of dealing with it in real time, making sure that everything was correct.
The ideal candidate for testing biologics in our new analytical department would be a company that is interested in producing a single monoclonal antibody in a drug that has concentrations in the milligrams or micrograms for milliliter. Our experience includes running monoclonal antibodies on HPLC with fantastic success. We were able to create a robust and accurate method with no problems. The transition between doing the small molecules and large molecules is minimal. It takes very little downtime - only a couple hours. Clients will find that they'll get the same quality results as anyone who has small molecule.
At the current 27% of approved therapeutics, Attentive will not be ignoring our client’s “large molecule” needs, especially given that our expertise is poised to offer services to that portion of the industry. We want to be a part of those projects – and offer our expertise to that part of ensuring healthier outcomes. Attentive has the ability and the experience to help our clients succeed! There are various types of techniques that can be used in our analytical department, including size exclusion, chromatography, reverse and normal phase chromatography. Now, there’s a new and exciting form of chromatography that has been developed for biologics and that's hydrophobic interaction liquid chromatography. This is a specialized form of normal phase chromatography that is used on the HPLC. It’s a really exciting new branch of testing biologics for any purpose, including the pharmaceutical. Watch out for this space and how we intend to support you.
Attentive’s new services will ensure you are getting the right data on time. You will not wait on your dose formulation data at Attentive Science.