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Process Development and Service Lab

The process development laboratory is designed to address key challenges for biomedical customers during process development and manufacturing in China.

Alioth laboratory also has membrane materials research and development center, process development service and pilot laboratory. According to the core development concept of DbA (Design by Application) and combined with the specific requirements of domestic biopharmaceutical enterprises, Alioth laboratory explores new technologies and products to support the research and development of biomedicine, as well as pilot test and scale-up production. Alioth equipped with advanced process development, pilot test equipment, and many technology experts who has been worked in biopharmaceutical industry for many years. Therefore, Alioth could assist customers for technical consultation, process development, product operation training and troubleshooting, in order to accelerate the development and transformation of biomedical research and development projects.

Validation Service Lab

Alioth validation laboratory provides validation services including Bacterial challenge, Extractables and Leachables, Compatibility, Product-based integrity test values and Binding studies for pharmaceutical manufacturers. It also conducts internal products validation and provides data for validation guide. The laboratory follows the ISO9001 quality management system and ensures data authenticity, accuracy and traceability, which are essential for data integrity.
The validation laboratory staff have comprehensive experience in process validation, scientific and reasonable validation methods to ensure that the filtration process meets the requirements of GMP regulations. Based on customer needs, the laboratory provides customer with a full range of validation services, including regulatory interpretation, consulting services of process and validation report evaluation, as well as process validation services for the products of our company and other companies.
The laboratory has advanced validation equipment including LCMS-MS, GC-MS, steam in place system, particle counter, which can provide customer with reliable validation data.