Bacterial endotoxin detection
We offer bacterial endotoxin testing services. Our testing methods meet all pharmacopoeia requirements (USP85, ChP1143), including gel-clot endotoxin test TAL and LAL methods. We also provide interference validation experiments and technical support services for our clients.
Aseptic examination
Direct inoculation and membrane filtration methods are classic sterility tests for products, designed to ensure the absence of viable contaminating microorganisms. These tests are performed in an isolator or cleanroom environment. Our testing methods meet all pharmacopoeia requirements (USP71, ChP1101).
• Test samples are directly inoculated into two culture media to detect aerobic and anaerobic microorganisms.
• After inoculation, both culture media are incubated for 14 days. Intermittent observation and a final observation at the end of the test period are performed to detect evidence of microbial growth.
• sterile closed filtration device allows equal volumes of test samples to be filtered simultaneously through two membrane filters.
• Samples are incubated in two culture media for 14 days to facilitate the detection of aerobic and anaerobic microorganisms.
Mycoplasma Testing
Mycoplasma contamination is a common problem in cell culture. Complicating matters further, contaminants can grow to high titers without showing turbidity or cytopathic effects, making detection particularly difficult. Cell substrates used in biopharmaceutical manufacturing must be proven free of adventitious agents, including mycoplasma. Mycoplasma testing must be performed at all stages of product development, including raw materials, cell banks, virus seed stocks, unprocessed bulk harvested materials, and final products.
Direct culture method
Test samples are directly inoculated onto agar plates/semi-fluid media and liquid media.
The selected agar/semi-fluid and liquid media have been proven to have good growth-promoting properties supporting the growth of multiple mycoplasma species.
Each mycoplasma detection test includes negative and positive controls to verify the suitability of the test system.
During the incubation period, liquid cultures are subcultured at multiple time points to observe mycoplasma growth.
At the end of the incubation period, mycoplasma contamination is assessed by observing the presence of mycoplasma colonies on agar plates or color change of the liquid medium.
The total incubation period is 28 days.
Indicator cell culture method
Some mycoplasma strains are considered "unculturable" because they do not grow in standard culture media. Cultures of Vero cells can be used for the enrichment of these mycoplasma strains. After a one-week culture period, the cells are fixed, stained with DNA-binding fluorescent dyes, and evaluated under a microscope.
In cases of mycoplasma infection, a characteristic pattern of bright fluorescence appears on the cell surface and surrounding area when contamination is severe.
Protein, peptide, vector, and plasmid products are particularly sensitive to environmental factors. Stability testing studies are used to evaluate the performance of biopharmaceutical products under different environmental conditions within a specific timeframe. The results determine recommended storage and transportation conditions for drugs and products, and identify appropriate shelf-life or retest periods.
Real-time and accelerated stability tests
Shelf life is typically estimated based on the results of real-time stability testing and accelerated stability testing. In real-time stability testing, the product is stored under recommended storage conditions and continuously monitored until it fails to meet product specifications. In accelerated stability testing, the product is stored under elevated stress conditions (e.g., elevated temperature and/or humidity). Degradation under recommended storage conditions can then be predicted using the known relationship between the acceleration factor and the degradation profiles rate.
Forced Degradation Studies
Forced degradation studies are conducted through stability studies under extreme storage conditions to accelerate degradation rates. Due to the non-linear nature of protein degradation kinetics, these studies have limited predictive value for shelf life in biopharmaceutical products. However, forced degradation studies are particularly useful in early-stage drug development because they provide information on product breakdown and degradation pathways, allowing for formulation optimization and assisting in determining storage conditions to control product stability.
Long-Term Stability Studies
For biopharmaceutical products, long-term stability studies are conducted under expected storage conditions, while short-term studies are conducted at higher temperatures to support in-use stability assessments and under transport conditions.