In Biotech Development, Initial Setup is Always the Slow and Expensive Part

October 7th, 2018 Permalink

Exploratory development in any given field of interest tends to become cheaper and easier as it progresses in a biotechnology company. This is not really driven by the team gaining experience, even though that is important for any number of other reasons, but rather because in the later stages of a project, more of the essential components of development have already been set up, and it is the setup cost that is largest in time and funding.

In any given line of development, a team might need cell lines, reagents, specific experimental procedures in cells and mice, the use of novel equipment, and so forth. Anything a team has already carried out and reduced to practice can be accomplished again with modest incremental effort, but each of these items requires a significant amount of effort to set up the first time. This is the nature of biotechnology, and it is why most contract research organizations are very limited in the services they can offer. It is thus also why more exploratory work than would be optimal must be taken in house by most biotechnology startups.

To take just the first of the line items mentioned above, cell lines can certainly be ordered from vendors or quickly generated from mice, but don't think that this means it is easy to obtain useful cell lines. A cell line from any source requires careful assessment and quality assurance before the cells can be used, as the rate of failure and contamination is high even for commercial products. So we must ask questions such as whether or not the cells exhibit the right surface markers. Is there consensus on what those markers should be? That is not always the case. Do the cells behave as they should in some standard assay? Does that standard assay exist, or are there other ways to answer the question, and has the team already worked with those protocols? If not, then validating the cell line will require a new protocol to be set up, and the protocol itself must be validated. That may require a new vendor and that vendor's products to be evaluated and the processes set up for their use by lab technicians. The rabbit hole can be quite deep even for items that might at first appear to be simple.

This exercise of validation can well turn out to involve anything from a couple of weeks to a couple of months of work, depending on the depth of the rabbit hole and the setbacks encountered along the way. But once the cell line is in hand and properly managed, and all the protocols written, and the team experienced in their use, any future project that can use the cell line no longer needs the lengthy setup process. It will thus be that much faster to carry out.

In later stages of investigation and development, it will often be the case that only one or two items are novel for any given project. Everything else is already in hand, or in the freezers, waiting to be reused. This can result in a factor of two or three difference in cost and time. On the flip side of the coin, everything in the early stages of a biotechnology startup is frustratingly slow and expensive. Expect it to take at least six months to get up to a reasonable speed in any one area of development, and that assumes no major diversions or changes in direction.