The production of HTBT's recombinant human insulin APIs (crystal powder) introduces from Israel technology with highly efficient expression escherichia coli (E.coli) and produce the high-pure recombinant human insulin after series of processes such as fermentation, refolding, purification, crystallization and vacuum drying. The recombinant human insulin APIs meet the current Chinese and European Pharmacopoeia standards and could be packaged for private use or export.
A 5000L fermentation-scale API production line (API I) was built in October 2013 and the production line was constructed with Chinese and EU GMP standards and is fully equipped with process equipment, Clean in Process (CIP), biological inactivation treatment systems, and public production facilities such as warehouse, distribution stations, gas-fired boilers, liquid oxygen&nitrogen station, solvent recovery station, pharmaceutical water and compressed air freezing. Meanwhile, environmental facilities such as wastewater treatment with reserve capacity were built. The introduced production line is highly efficient, energy-saving, and eco-friendly, and all the key equipment imported from Europe and the United States, are highly automatic. The production line, based on the platform technology designed by Israel, can produce recombinant human insulin and insulin analogues.
API I's annual designed production capacity of recombinant human insulin crystals can reach 1000kg. In November 2013, the commissioning run test was conducted for the first time and became successful at a time. Since August 2014, the production process validation for raw materials of recombinant human insulin, novel long acting insulin analogues, and recombinant insulin glargine has been completed. API I has successively passed the GMP pre-audit of EMA and TGA.
The building where API I is located has reserved necessary space for construction of API II and when it's completed, the production capacity of API will be doubled.