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:
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Our R&D and cGMP integrated production base is built in accordance with high standards and covers 35,007 m2.
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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.
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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.
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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：
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Hande is committed to applying advanced technology to research and production applications for many years.
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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.
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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.
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In addition to use of batch reactions, hazardous reactions can be accommodated using flow chemistry, including in hybrid modes.
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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.
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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.
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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.