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 three 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 deconvoluted average mass | Verified |
| Amino-acid analysis available on request | Verified |
| ISO 9001 certification | Verified |
| Custom-synthesis sequence confirmation | Verified |
| Independent third-party testing on a per-batch basis for catalogue lines | Not verified |
| Endotoxin for research-grade lines | Not verified |
| Sterility | Not assessed |
| Aggregate content for the amylin class | Not assessed |
| Verified — documentation supporting the claim was examined. Not verified — the Institute looked for supporting documentation and did not find it. Not assessed — the Institute did not examine this attribute, which carries no implication about it. Verification is of documentation and never of product. | |
§1.2bDistribution and dispatch
The supplier maintains regional stock in six countries, so material reaches a purchaser from a warehouse in their own jurisdiction rather than from the manufacturing site: Netherlands (Rotterdam), serving European Union, typically 2-4 days; Germany (Hamburg), serving Germany, Austria, Switzerland, typically 2-4 days; United Kingdom (London), serving United Kingdom & Ireland, typically 2-3 days; United States (California), serving United States, typically 2-4 days; Canada (Toronto), serving Canada, typically 3-5 days; Australia (Melbourne), serving Australia & New Zealand, typically 3-5 days. The Institute records this because dispatch origin bears on the cold-chain history of any lot it assesses.
§1.3Coverage limitation
§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, requested or was refused. 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 was on offer.
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.