Production Of Insulin APIs
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.
HTBT has two small-capacity injection workshops, a packaging workshop, and an oral capsule workshop (under construction) for the production of injection production.
One of the two small-capacity injection workshops is Formulation & Filling I, which covers about 500 m2 and is designed and built in accordance with the CFDA GMP standards. Formulation & Filling I, with one integrated washing, filling and capping line, the ability of producing cartridges and vials and a designed capacity of 12 million /year, has been put into use, and has completed process validation and production of injection products such as recombinant human insulin products (cartridges and vials), novel long-acting insulin analogue injection (cartridges), and recombinant insulin glargine injection (cartridges).
Formulation & Filling II covers about 900 m2 and is designed and built in accordance with the EU GMP standards. There are two automatic washing, filling and sealing line for cartridge and vials production respectively in Formulation & FillingIIwith a designed capacity of 60 million /year, and all the production equipments are imported equipment in line with the American and EU standards, laying firm foundation for the future development of European and American markets. The packaging workshop covers 630m2, and adopts imported automatic production equipment linked with light inspection and packaging, with the packaging ability of both packaging cartridges and vials. It is the supporting workshop that provides services for Formulation & Filling I and II.
Moreover, we have an oral insulin capsule preparation in the development stage. The product has passed through the United States' FDA clinical phase II, and the workshop is in the design and construction stage.
The company has introduced advanced Israeli production technology, upheld the production concept of excellence and efficiency, strictly complied with the GMP requirements, adhered to the quality policy of "quality first, continuous improvement, scientific management, and pursuit of perfection" and built a rigorous, executable core team to provide safe and effective quality products for patients.