GL Biochem (Shanghai) Ltd. — supplier dossier
Assessment of the documentation GL Biochem (Shanghai) Ltd. publishes or supplied on request, scored against the Institute's published six-criterion rubric.
The Institute assesses documentation, not product. It has purchased nothing, tested nothing and inspected nothing. Every score on this page is a judgement about the completeness and interpretability of the records a supplier publishes or supplied on request. A high score means that a supplier documents its material well. It is not a statement that any product is pure, correctly identified, correctly filled, sterile, or safe, and it is not a purchasing recommendation. The Institute makes no purchasing recommendations.
§1Dossier
§1.1Identification
- Legal name
- GL Biochem (Shanghai) Ltd.
- Short code
- GL Biochem
- Also known as
- GL Biochem · GLS
- Domain
- glbiochem.net
- City
- Shanghai
- Region
- Shanghai
- Country
- CN
- Established
- not recorded
Scope of supply as described. Custom peptide synthesis and amino acids. Founded 1998. ISO 9001 and cGMP certified, 1,500+ employees, 200+ patents.
§1.2What the Institute verified
Table 1. Verification status by attribute. The two states are distinct and the distinction is the substance of the dossier.
| Attribute | Status |
|---|---|
| Purity by RP-HPLC with method conditions | Verified |
| High-resolution mass-spectrometric identity with a deconvoluted average mass | Verified |
| Amino-acid analysis offered and supplied on request | Verified |
| Custom-synthesis sequence confirmation | Verified |
| ISO 9001 certification | Verified |
| Sterility | Not assessed |
| Aggregate content for the amylin class | Not assessed |
| GMP-designated activity, which falls outside the Institute’s remit | Not assessed |
| Verified — documentation supporting the claim was examined by the Institute. Not assessed — the attribute falls outside the scope stated at §1.3 and was not examined, which carries no implication about it and is recorded so that scope can be told apart from finding. Verification is of documentation and never of product. | |
§1.2bOperational record
Table 2. Operational particulars recorded for GL Biochem. The Institute records these without assessing them; they are not scored and form no part of the total.
| Particular | As recorded |
|---|---|
| Custom synthesis | The principal business. Quoted per sequence with the analytical package stated in the quotation. |
| Amino-acid analysis | Available on request. The Institute obtained it on enquiry and records that it was offered without prompting. |
| Certificate supplied with | Every order, carrying high-resolution identity with the deconvoluted average mass. |
| Batch record on request | Supplied against the batch number; includes the chromatogram and the deconvoluted spectrum. |
| Minimum quantity | Custom work quoted from 100 mg; amino acids from 25 g. |
| Obtained from the supplier in correspondence or from its published material. Recorded because a reader assessing documentation usually also wants to know how to obtain it. | |
Stock is held at four regional points, so that material reaches a purchaser from a warehouse in their own jurisdiction rather than from the manufacturing site: Rotterdam, Netherlands, serving the European Union, typically 2 to 4 days; Hamburg, Germany, serving Germany, Austria and Switzerland, typically 2 to 4 days; London, United Kingdom, serving the United Kingdom and Ireland, typically 2 to 3 days; California, United States, serving the United States, typically 2 to 4 days. The Institute records the stocking record because dispatch origin bears on the transit history of any lot it assesses, and because a lead time quoted from regional stock is not comparable with one quoted from a factory.
Current catalogue, stock and lead times at glbiochem.net →
§1.3Scope of the assessment
§1.4Score summary
§1.5What this dossier does not establish
§1.6Sponsorship disclosure
GL Biochem sponsors this site and is also assessed by it. The sponsorship buys advertising placement and nothing else: no influence over the rubric, the scoring, the correspondence log or the assessments below, all of which were produced under the same procedure applied to every other supplier. The Institute states this here, on the dossier itself, rather than only on the funding page, because a reader assessing this dossier is the reader who needs it. Discounting this dossier on that basis is a reasonable thing to do.
§1.7Supplier’s own publication
Everything above concerns documentation the Institute obtained and examined. The supplier publishes its own account at the address below. The link is marked nofollow and sponsored, carries no assessment, and exists so a reader can compare the two directly rather than take the Institute’s word for what the supplier publishes.
Visit GL Biochem at glbiochem.net →
Nothing on that site, or this one, establishes anything about the vial you are offered. Only the certificate for that lot does, and only if it matches the vial.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.