FAQ

FAQ

Peptide

1.What is peptide?

Molecular Hiving™

2.What is Molecular Hiving™ technology?

3.What is advantages of Molecular Hiving™ comparing to traditional technologies?

4.What kind of peptides can Molecular Hiving™ produce?

5.What is the track record of manufacturing peptides through Molecular Hiving™ ?

We have manufactured a certain peptide at 100s g to 1kg batch scale.

6.Any reference literatures?

Refer to “related literatures”.

7.What is the yield% of elongation step?

Yield of each step of elongation is ca. 99%.

8.What is the concentration of reactant at elongation stage?

Depends of peptide sequence. Usually, 10mmol/L to 100mmol/L.

9.What is the organic solvent used for the Molecular Hiving?

Combination of 2 to 3 hydrophilic and hydrophobic solvents are used.

10.What is required volume of amino acids and elongation agents in terms of equivalent?

1.1eq to 1.5 eq.

11.What is the status of patent application?

See "About patent"
Manufacturing

12.What kind of facility and equipment Jitsubo have?

Refer to the "equipment list".

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?

No limitation.

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.
Analytical method

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 guidelines.

22.What kind of the analytical equipment Jitsubo has?

Refer to the "equipment list".
Regulatory Affairs

23.Can Jitsubo conduct the release QC test?

Possible. A part of test method needs to use CRO.

24.Does Jitsubo have and maintain the quality management system?

Yes, we have GMP-SOPs and R&D best protocols including the organization.
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