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Biotech / Medical : BJCT-BIOJECT-needle less injection product -- Ignore unavailable to you. Want to Upgrade?


To: Marc Kahn who wrote (69)11/7/1997 12:32:00 AM
From: Marc Kahn  Read Replies (1) | Respond to of 534
 
My wife and I visited Bioject's headquarters Thursday. We got flu shots and a tour / talk.

My shot hurt and her's didn't. The nurse said that the level of sensation is very subjective. I felt like my skin was being penetrated, and it was pretty uncomfortable (equivalent to a needle). My wife felt a brief "sensation", but it wasn't painful for her at all. Go figure.

Our tour was guided by a fellow named Mike, who is responsible for dealing with regulatory affairs (FDA, etc.). The employees were all very congenial and projected an attitude of both commitment and teamwork. They are proud of what they are doing.

We saw ampules being manufactured, in a clean room environment. All of the component parts are manufactured by outside vendors, with assembly and packaging performed in-house. It's pretty labor intensive, with a lot of repetitive, boring work. There is a big push on to automate the repetitive stuff and thereby lower costs. We saw some new equipment which had just been installed, and some more which is being developed. They seem committed to lowering production costs, and I suspect that if finances hadn't been so tight, that they would be much further along.

We also saw 2 separate Biojector manufacturing areas, which were inactive. One is for the Biojector 2000, their existing device, which is designed to be used by health care professionals. They have a large inventory of these and no need to manufacture more at this point.

The other manufacturing area is for a new product, their self-injector, which was developed with Schering AG, specifically for Multiple Sclerosis patients to inject themselves with BetaSeron (beta-interferon). Since MS patients are motor-impaired, this injector needs to sense whether it is loaded correctly and held against the skin correctly before it will deliver an injection. The sensors and electronics which are built into this device make it impossible to screw up a self-administered injection. This is a very impressive engineering feat! When Schering walked away from this, Bioject retained all rights to this device. Contrary to a prior posting, here on SI, Mike assured me that Bioject is in no way restrained from marketing this device to other drug companies, including suppliers of MS injectable therapies. He told me that they are about to submit this device for FDA approval.

I'm reading between the lines here, but why would there be a manufacturing area and a request for FDA approval, if there wasn't something up? Previous postings here have mentioned on-going attempts to partner with various pharmaceutical companies. This could turn into something exciting, perhaps soon. I'm looking forward to that.

Marc Kahn