Lead time for manufacturing depends on amino acid sequence,
number of amino acids (mer), including non-natural amino acid,
molecular structure such as existing side chain and/or SS bridged,
required amount, and the purity. Jitsubo manufacture the peptide
according to the client requirement flexibly.
15.Please show In-process control ?
The reaction is controlled by UHPLC and TLC.
16.What is meaning of CMR Free?
Carcinogenic, Mutagenic, and Reproduction Toxicity free.
17.Is the formulation development of peptide possible to conduct at Jitsubo?
Jitsubo has experiences to develop the formulation, however, recently
focused on API manufacturing and currently hove no plan.
Analytical method
18.Is it possible to develop the analytical method for the product?
Possible. A part of test method needs to use CRO.
19.What are the acceptance criteria of API?
Jitsubo set the acceptance criteria according to the regulations and/or
guidelines.
20.What kind of the analytical equipment Jitsubo has?