High potency plant to come on stream in June
Asymchem, a US-based contract manufacturing organisation with all its r&d and manufacturing activities in China, is to open its new, dedicated cGMP compliant high potency facility in Tianjin, China, in June 2009.
Asymchem, a US-based contract manufacturing organisation with all its r&d and manufacturing activities in China, is to open its new, dedicated cGMP compliant high potency facility in Tianjin, China, in June 2009.
The plant, which is being built in the shell of a former non-GMP pilot plant, will be able to handle compounds in the Category 3 and 4 bands of the Safebridge scale.
Two API suites will be opened initially, with 5 - 50-litre and 100-litre reactors respectively. Equipment trains are designed for maximum flexibility with solids dispensed in a controlled area and solutions transferred to reactors, then back to the controlled area for filtration/drying. The operating temperature range is -80 to +150°C.
The facility will also have dedicated analytical equipment for potent compounds for in-process control and release testing, as well as appropriate instrumentation for developing, validating and performing cleaning assays.
The new capability to prepare highly potent compounds complements Asymchem's existing ability to prepare drug products for this class of compounds. Drug product manufacturing and packaging suites are within the same facility as the API suites, enabling the company to offer complete high potency manufacturing services in one centralised location.
In addition the company is building a large-scale GMP/non-GMP production plant in Dunhua. Phase I of the project will involve reactors from 5,000 to 20,000 litres and will come on stream in June 2009.
Asymchem has also launched its Integrated Chemical and Pharmaceutical Services programme, aimed at accelerating the development of drug candidates to Phase I clinical trials.
The programme includes: chemical process development; formulation development; API synthesis and manufacturing of drug products for toxicology and clinical studies; API and prototype formulation stability; and technical writing of the CMC section for IND filings.
As many different parts of the programme as possible are carried out concurrently, and Asymchem projects that the time from candidate selection to clinical trial drug product release could be reduced to 8-9 months from the current industry norm of 15 months.