Our production plant can support customer needs ranging from GLP tox lots, Phase I-III clinical supplies to full-scale commercial production on up to MT quantities for pharmaceutical and biotech companies.
High standard production plant and manufacturing capacity:
Our R&D and cGMP integrated production base is built in accordance with high standards and covers 35,007 m2.
The manufacturing facility has 1 R&D building, 3 pilot and commercial workshops, 1 administration building, 3 warehouses, and various ancillary facilities including utilities and waste treatment.
The total reactor volume of the existing plant is more than 60,000 L, and plans are to install more than 100,000 L of reactor volume, including cGMP manufacturing units for high potency APIs.
The plant is equipped with reactors ranging in size from 50 L to 5,000 L so as to meet the production needs of projects at different stages of development. The reactor configuration allows for the handling of a variety of challenging chemical reactions (i.e., cryogenic reactions, including organometallic reactions (n-BuLi, MeLi, Grignard reagents etc.), reductions (using LiAlH4, NaBH4, Red-Al etc.), Pd, Pt, Rh, Ru, Ir catalyzed reaction, nitration, bromination, fluorination etc.).
Advanced production technology：
Hande is committed to applying advanced technology to research and production applications for many years.
When encountering the risks and challenges that can occur when laboratory-scale reactions are scaled up, our experienced production team uses their extensive industry experience to ensure the process is suitable for commercial production.
The plant is able handle a range of challenging reaction conditions including temperatures as low as -110 oC , temperatures as high as 140 oC , pressures up to 4 atm, and hazardous reactions including oxidations, asymmetric catalytic hydrogenations, diazotizations, and water- and oxygen-sensitive precious metal catalysis.
In addition to use of batch reactions, hazardous reactions can be accommodated using flow chemistry, including in hybrid modes.
HAZOP/LOPA risk assessments are adopted at the design stage, and DCS systems, SIS systems and engineering control systems (OEB4, OEB5) are applied throughout the production process.
At the end of a production campaign, a complete technical package including a process development report, method validation report, batch production record, process validation plan, and process safety risk assessment report will be provided to customers together with delivery of the product.
Since inception, Hande has provided process R&D services and commercial products for many of the world’s top 50 pharmaceutical companies.
Please feel free to contact us if you have any questions.