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Biopharmaceutical Stability Research Test

2015-11-12
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Medicilon drug stability research service content

Stability of global drug registration; Stability of trial/exploratory (pre-experimental); Stability of drug after approval
Provide comprehensive services such as scheme design of stability research, project management, stability sample storage and testing, data trend analysis, drug shelf life evaluation, and NDA/MAA filing dossier preparation
Storage conditions: 40°C/75%RH, 30°C/75%RH, 30°C/65%RH, 25°C/60%RH and light, or the storage conditions specified by the customer include
2-8°C, -20°C, -70°C, 25/40, 30/35, 40/20, 50/40 (new)
Qualified stability research constant temperature and humidity box (IQ/OQ/PQ certification); multi-channel power supply; real-time temperature and humidity monitoring (dual systems); automatic alarm system

Drug stability test

Stability research content: Judgment on the rationality of product production process, formulation prescription, and packaging material selection
Before carrying out stability research, it is necessary to establish an overall plan or plan for stability research, including research samples, research conditions, research projects, research time, transportation research, and analysis of research results.
The stability research of biological products generally includes real-time stability research under actual storage conditions (long-term stability research), accelerated stability research and forced condition test research.

  1. Sample: The research sample usually includes the original solution, the finished product and the dilution or resuspension that comes with the product

  2. Conditions: The stability study conditions should fully consider the entire process of storage, transportation and use in the future. Based on the preliminary research results of various influencing factors (such as temperature, humidity, light, repeated freezing and thawing, vibration, oxidation, acid-base and other related conditions), formulate long-term, accelerated and forced condition tests and other stability research programs.

  3. Test items: The test items should include items that are sensitive to the product and may reflect the quality, safety and/or effectiveness of the product, such as biological activity, purity, and content.

  4. Time: The general principle for the long-term stability study time point is to check every three months in the first year, every six months in the second year, and once every year from the third year.

  5. Transportation stability research: Biological products usually require cold chain storage and transportation, and corresponding stability simulation verification studies should be carried out on the transportation process of products (including liquid and finished products).

  6. Analysis of results: A reasonable result evaluation method and acceptable acceptance criteria should be established in the stability study. The different test indicators in the research should be analyzed separately; at the same time, the stability of the product should be comprehensively evaluated.

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