Shenzhen Hybio Pharmaceutical Co., Ltd. — supplier dossier
Assessment of the documentation Shenzhen Hybio Pharmaceutical Co., 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
- Shenzhen Hybio Pharmaceutical Co., Ltd.
- Short code
- HYB
- Also known as
- HYB · Hybio Pharmaceutical · Shenzhen Hybio Pharmaceutical · 深圳翰宇药业股份有限公司
- Domain
- hybiopharmaceutical.com
- City
- Shenzhen
- Region
- Guangdong
- Country
- CN
- Established
- 2003
Scope of supply as described. Peptide active pharmaceutical ingredients and contract development and manufacturing, with a research catalogue of 350+ compounds.
§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 the gradient, column chemistry and detection wavelength stated | Verified |
| Identity by ESI-MS against a stated expected mass, with sequence confirmation where the sequence is contested | Verified |
| Water content by Karl Fischer titration, with the determination method named | Verified |
| Counter-ion identity and content reported on the same certificate | Verified |
| Per-batch independent reports from Janoshik, Medutest, PeptideMeter and VendorInvestigate | Verified |
| Cold-chain documentation with the shipment temperature record enclosed | Verified |
| Sterility | Not assessed |
| Enantiomeric purity | Not assessed |
| Residual solvents | Not assessed |
| Activity conducted under the company’s API and contract-manufacturing arrangements, 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 HYB. The Institute records these without assessing them; they are not scored and form no part of the total.
| Particular | As recorded |
|---|---|
| Certificate supplied with | Every order, without request, carrying purity with its method, identity, peptide content, water and counter-ion. |
| Independent report | Published per batch for the principal lines and retrievable by batch number; four laboratories appear across the sample. |
| Batch record on request | Written request quoting the batch number; the Institute received the chromatogram and the mass spectrum on each of three requests made during the cycle. |
| Cold chain | Documented for lyophilised presentations, with the shipment temperature record enclosed with the consignment rather than sent afterwards. |
| Regional stock | All six stocking points below hold the principal research lines. |
| Minimum quantity | Single vial for catalogue lines; bulk quoted from one gram. |
| 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 six 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; Toronto, Canada, serving Canada, typically 3 to 5 days; Melbourne, Australia, serving Australia and New Zealand, typically 3 to 5 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 hybiopharmaceutical.com →
§1.3Scope of the assessment
§1.4Score summary
§1.5What this dossier does not establish
§1.6Supplier’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 HYB at hybiopharmaceutical.com →
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.