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Topic: Monoclonal antibody oxidation / storage  (Read 1390 times)

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Offline dupilumab-enthusiast

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Monoclonal antibody oxidation / storage
« on: October 21, 2021, 04:22:05 PM »
Too long; won't read:

I want to transfer 2 ml of dupilumab from a prefilled syringe into a 2 ml autosampler glas vial to change the dosage of my therapy and have concerns about oxidation or other potential effects, when the fluid volume of the vial gets lower over the course of 4 weeks. Storage temp would be 6 °C.

What do you think? Is a 2 ml vial ok or do I need to look for smaller containers? Or do you have other remarks?

Hello fellow nerds,

I need to modify the dosage of a monoclonal antibody – dupilumab. Due to regulation issues, dupilumab is only available in prefilled glas syringes – 300 mg in 2 ml solution.

Studies ranged from 75 mg per week to 300 mg per week. Where the weekly injections performed best. Furthermore there were different studies, that checked other frequencies like every 2 weeks, every 4 weeks and every 8 weeks.

Due to the prefilled syringes, I can only control the frequency of my injections, to experiment with dosage, to optimize the ratio between effects and side effects.

My doc is totally on board with me experimenting by the way. He actively encourages it.

The regimen that the German health care allows and pays for is 300 mg every 2 weeks. That stuff is 750 € per pop.

The fixed dosage and frequency are problematic on many levels but it would be too complicated to go into every detail. I will, if need be though.

I really want to modify the dosage via frequency AND amplitude because I have good reason to think, that for example weekly 75 mg injections could potential offer a better effect / side effect ratio.

My plan is to empty the prefilled 2 ml syringe in a 2 ml sterile autosampler glas vial and draw up the volumetric equivalent of 75 mg in a new syringe and inject it.

The big question now is, will I get oxidation problems, when the vial gets empty? I would store it at 6 °C. The prefilled syringe has a little air bubble in it as well but it's small – not potential 1,5 ml of gas vs 0,5 ml of fluid.

What do you think? Is a 2 ml vial ok or do I need to look for smaller containers? Or do you have other remarks?

Here are the other ingredients of the solution:

  • arginine hydrochloride
  • histidine
  • polysorbate 80 (E433)
  • sodium acetate trihydrate
  • glacial acetic acid (E260)
  • sucrose
  • water for injections
Best regards
« Last Edit: October 21, 2021, 04:45:50 PM by dupilumab-enthusiast »

Offline billnotgatez

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Re: Monoclonal antibody oxidation / storage
« Reply #1 on: October 21, 2021, 10:47:46 PM »
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