13.Can the GMP compliant manufacturing be conducted at Jitsubo?
Jitsubo has the GMP for IMP compliance facility and maintenance
standard procedure. Manufacturing such as over 1kg per year is
conducted at CMO partner’s facility.
14.Who is the CMO partner?
Jitsubo has the CMO partners in Asia and Europa.
15.What is the scalability?
16.What about the lead time for manufacturing?
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.
17.Please show In-process control ？
The reaction is controlled by UHPLC and TLC.
18.What is meaning of CMR Free?
Carcinogenic, Mutagenic, and Reproduction Toxicity free.
19.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.
20.Is it possible to develop the analytical method for the product?
Possible. A part of test method needs to use CRO.
21.What are the acceptance criteria of API?
Jitsubo set the acceptance criteria according to the regulations and/or
22.What kind of the analytical equipment Jitsubo has?