Cost of method development?
Posted: Sun Feb 16, 2020 7:52 pm
by MaxSpecs
I was wondering what would be the price of hplc method development?
Say a relatively complex imps method for pharma, full service from column screen to final validation. Resolution as well as business attributes taken into account, like resource footprint, analysis time, etc.
Sample prep not in scope as there is too much variability to put average a price on it.
Re: Cost of method development?
Posted: Mon Feb 17, 2020 2:13 pm
by Consumer Products Guy
As many times as we did this in-house, I couldn't really give a decent guess at what this would cost on the outside.
I could develop some methods in a couple of days that would turn out to be great for our products, and other analytes in certain matrices could take over a month or more. Sometimes columns would need to be obtained. Typically, if we could find anything even a little related, we would draw from literature, we did not believe in re-inventing the wheel.
cGMP Validation studies would follow and would hopefully pass. Validation alone could take a month or more. If your QA is super-anal, maybe triple that. We had analytes that would not degrade under the very-vague published guidelines. We always had 2nd and 3rd operator do samples as well, and used different instruments and columns intentionally.
Figure outside lab costs at maybe $150 per hour. Since ours were done in-house I didn't need to factor in instrument or supplies costs.
Re: Cost of method development?
Posted: Wed Feb 19, 2020 6:18 pm
by Vlad Orlovsky
From my experience the range is relatively broad. We charge $175/h or per project, most of our projects are in the range of $8,000 to $50,000. There were couple of them which were less and couple, really tough methods, which cost more. Since we have all columns in stock we don't charge our customers for columns, plus if they accept our method we provide them with a credit for columns being used to verify the method.
See more here:
https://helixchrom.com/services/method-development/
We also have method development kits which cover 98% of applications.