Replies to post #109072 on Biotech Values

[jbog]

Biowatch,

I would think that the finish product (A-623) has been lyophilized (freeze dryed). This is a somewhat complex process in that after the liquid has been put into the vial it immediately is put in an absolute vacuum and then the temperature is lowered to minus 70 degrees C. Then over the next day or so it is gradually heated so that almost all the liquid fractions go through sublimation. What is left in the vial is a powdered crystal structure that the doctor will reformulate by injecting sterile water into before administering it to the patient.

Lyophilization is common in Mabs, Vaccines and Recombinant Proteins. Freeze Drying imparts higher stability, broader temperature tolerance, and longer shelf-life to most pharmaceutical formulations that are unstable in aqueous solution.

Now getting back to your question. The stresses that are impacted on the glass vial due to the extreme temperatures are not always seen initially and then show up later after the vials are tossed around a little. They can correct this problem easily.

Sanofi originally had this problem when commissioning Oxaliplatin, sadly they were processing 196,400 vials for each test.