I have not put pen to paper (Okay. Fingers to keys) on process development lately. I can’t discuss much in the way of specifics. But there are some generalizations that can be put on the table for discussion.

When should you outsource a raw material? Depends. Does the process for the raw material match your skill set? Namely, does it require, say, bromination of an olefin or an aromatic ring? This can be deceptively troublesome. It is easy to scribble down a reaction mechanism for a bromination. It can seem like a no-brainer to say “yeah, we can do that”. Same is true for a Sandmeyer or a Friedel-Crafts reaction or some oxidation reaction for instance.

You may not do much of a particular kind of transformation or handle certain reagents enough to have an institutional expertise to safely handle some materials. You may have safety kingpins who will nix some reagents because they don’t like the looks of the MSDS.  Or, your pots and pans may be booked well into the future and you have no opportunity to make the raw material.

The trouble with outsourcing a raw material is that the supplier’s price is your cost which must be passed along to your customer. You may or may not have the margin to play with to do much outsourcing.  If you suddenly need to outsource a raw material, you will have to find a shop that will make the stuff.  Preliminaries include doing a secrecy agreement, a disclosure of the desired material, and possibly disclosing a technology package.  After the disclosures it might transpire that the vendor isn’t interested, they can’t do the job in the desired time frame, or they want too high of a price. Lots of things can go wrong.  Meanwhile, you’re relentlessly screaming down the timeline towards you’re own delivery date. You should be planning your outsourcing 6 to 12 months in advance. Or even 18 months.  Outsourcing always involves the discovery of new failure modes.

Let’s say that they agree to work up a quote. There is the matter of specifications. They’ll need to know some specifications even before they quote a price.  What kind of purity are you needing? Be reasonable now. There is what you want and what you can get by with. OK, you can live with “97 % purity”. What does that mean? Does it include solvent residuals? What about color and haze or mesh size and appearance? If it comes in at 96.8 %, are you sure you want to reject it?  If it can be easily reworked, and you have the time to spare, rejecting the material might be the best choice. But if they are late and you are late, you may have to take the material on waiver.

Apart from the mere chemistry is the matter of TSCA regulations and/or import restrictions. Will your vendor have to file for an LVE (low volume exemption) or is the material already on TSCA?  An LVE will take time even if everything goes well. Need to put these regulatory filings into the timeline.  Want to import bulk Hazardous When Wet materials? Plan on a boat ride across the ocean.

Asking a company to develop a new product for you requires good communication, person to person relationships, and lots of patience.  Your custom vendor may be smaller than you are and may have considerable resources tied up in your order. They’re taking some risks as well. Shoot for win-win.

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