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Commercializing Aptamers: The Importance of SOPs

    Scriptorium was a word used in medieval times to describe a place reserved for copying manuscripts. Now, every company developing aptamer based commercial products should define their own scriptorium, even if this refers to an online space. The most important guide for all aspects of commercial development is the standard operating procedure (SOP).

    It is a good idea to develop SOPs, even when you are still optimizing product concept prior to prototype development. It is good scientific practice to only alter one variable per experiment; the best way to ensure you are doing this is to write up a clear process so you are sure that this is the only variable being evaluated.

    These early SOPs form a basis for your eventual product SOP, and even product inserts. The best way to test an SOP is to have someone, other than the person that wrote it, try to replicate the experiment. Reading SOPs is not a sufficient test. Everything can seem clear until you are actually in the lab performing the experiment.

    A key aspect of an SOP that is often overlooked in these early stages is defining what results are acceptable and what results mean that what you have done has failed. Specifications for acceptable performance should be defined for every step in the process, even if you do not usually measure it. This can require a lot of creativity and a different kind of thinking. This may strike you as unimportant for daily experiments, but this becomes crucial when the process is scaled to levels involving more cost for failure. To establish meaningful specifications often will require purposely altering variables to cause failure and determining at what threshold these alterations become a problem. You need to understand what does not work as well as you understand what does work.

    A key advantage to working with NeoVentures is our expertise with commercializing aptamers. We know SOPs and we can work with your team as advisors in every stage of development. If you do not have a scriptorium yet, we can help you build it.