Other contract labs now say they too can
provide biophysical analysis services such as AUC or CD. Some of them don't
actually do the work themselves, or they do it in some university laboratory.
Some make statements on their web pages that show they do not understand the
basic principles of the methods.
Having the equipment, or access to it,
is simply not enough---these are highly specialized methods requiring significant
experience to properly gather and interpret the data. The key questions you need
to ask are:
Who is doing the work?
- Who actually runs the experiments? Who analyzes and interprets the data?
- What is their experience with this technique?
- What is their publication record with this method?
- Do they have a track record of innovation with this method?
- How many different proteins have they worked with?
- Do they have experience working in the biotech industry, doing product
What is the company's track record?
- How long have they been doing this type of analysis?
- How many projects have they completed, for how many different clients, on
how many different products?
Where are they doing the work? With what equipment?
- If the work is being done at some university or institute facility, how
can you be sure the equipment is working properly?
- We have learned from decades of experience that for these
methods OQ and/or other testing by the instrument manufacturers is simply
insufficient to guarantee reliable results.
- Does the contract lab have its own sample cells to ensure the quality of
the cells and that they are properly cleaned to avoid cross-contamination?
- For AUC, does the contract lab have a cell alignment tool to help improve
- How is data integrity and security handled?
The A.P.L. difference!