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Facilities

SPK has five process R&D laboratories, a kilo development laboratory to handle process scale-up as well as producing kilogram-scale materials, and a newly commissioned manufacturing facility in Taicang equipped with reactors ranging from 300-3000 L. This facility has been used for the synthesis of non-GMP intermediates for ScinoPharm Taiwan's generic APIs as well as  intermediates.





Process R&D laboratories


Our approximately 25 strong R&D staff work in five dedicated process laboratories having standard laboratory equipment including staff operated HPLCs (Shimaza LC-20AT Prominence Liquid Chromatography). Via our ARD/QC laboratory, our R&D staff have access to Chiral HPLC, achiral/chiral GC, polarimetery, IR, Karl Fisher titration, UV-Vis, stability Chamber, LOD, and ash analysis, which are all conducted by Analytical Research and Development (AR&D) staff with proper quality control. Our AR&D staff also conduct chiral and a chiral method development for GC and HPLC. DSC/TGA/X-Ray (single crystal/powder diffraction) analysis is conducted through ScinoPharm Taiwan or the Shanghai Institute of Chemistry (SIOC).

Reactions are conducted at scales between 5 mL and 20 L. Our R&D staff are led by experienced group leaders. Each group leader is responsible for one R&D laboratory.

In R&D we develop patent non-infringing Generic API processes followed with technology transfer to our Taiwan parent (SPT) for cGMP production. We also develop patent non-infringing process for API intermediates as well as pre-GMP scale-up development for CRO customers ( via ScinoPharm Taiwan). We have produced four patents from development at this facility.

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NMR spectroscopy laboratory

Our R&D staff have access to 1D and 2D (e.g. COSY, DEPT, NOESY, HMCQ, and HMBC) spectroscopic analysis using our Varian 300 MHz multi-probe ( 1H, 13C, 31P and 19F) NMR spectrometer which has a dedicated operator.

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Analytical R&D/QA/QC laboratories

In this department we conduct instrument qualification and calibration, method validation, document control and conduct staff training . Our quality system is GMP appropriate and we follow SOPs, conduct material qualification, and produce Production Batch Records. We also conduct equipment cleaning and change control, and provide COAs for product release. The following equipment is utilized by this department:

  • Audolph Autopol III polarimeter
  • Nicolet FT-IR Avator 360
  • Metrohm 831 Karl Fisher titrator
  • Metrohm 794 Auto-titrator
  • Agilent 8453 UV-Vis spectrometer
  • Agilent 1100 DAD&VWD&RID HPLC (x 4)
  • Agilent 1100 DAD HPLC (x 2)
  • Shimadzu GC-2010 AF GC with TurboMatrix 16 Headspace sampler
  • Agilent 4890 GC
  • Agilent 6890 GC (x 2)
  • GIANT stability chamber


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Kilo laboratory

Our Kilo laboratory, which is used for both first stage scale-up as well as production of kilogram quantities of material, was completely refurbished in late 2006. The laboratory is equipped with:

  • 2 x 50 L glass-lined reactor
  • 2 x 30 L glass-lined reactor
  • 2 x 20 L glass reactor
  • 2 x 10 L glass reactor
  • 2 x 30 L glass extractor
  • 2 x 30 L stainless steel hydrogenator
  • 50 L Rotavap
  • 50 L Pressure filter with agitator
  • 3 x Vacuum oven dryer
  • Separate utility heating and cooling (-15 °C to 130 °C)
  • Utility 10 mmHg vacuum
  • 1 x 10 L S316 Centrifuge
  • 1 x 300 mm S316 Cymbals filter
  • 2 x stainless steel chromatography columns (20 cm ID x 2 m length)

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Hydrogenation Laboratory

Our hydrogenation laboratory is equipped with the following hydrogenators:

  • 1 x 300 mL hydrogenator (up to 200 bar; r.t. to 350 °C)
  • 1 x 1 L hydrogenator (up to 220 bar; r.t. to 350 °C)
  • 1 x 2 L hydrogenator (up to 100 bar; r.t. to 300 °C)
  • 2 x 30 L stainless steel hydrogenator (up to 6 bar; r.t. to 95 °C)

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non-GMP API intermediate manufacture

A newly leased production facility, fitted with reactors, a control room and an analytical room, was commissioned in late 2006. This facility is located in TaiCang, 40 minutes drive from Kunshan, and is fully operated by our own production staff. This facility is dedicated to production of non-GMP API intermediates for ScinoPharm Taiwan . The facility is equipped with 14 reactors with a total reactor volume of 20 m3. The configuration allows two concurrent production lines. IPC (in process control) utilizes dedicated Agilent 1100 HPLCs and Agilent 4890 GCs.

  • 2 x 3000 L glass-lined (-10 to 140 °C)
  • 5 x 2000 L glass-lined (-10 to 140 °C)
  • 2 x 1000 L glass-lined/stainless steel reactor (-10 to 140 °C)
  • 2 x 500 L glass-lined reactor (r.t. to 200 °C; -10 to 140 °C)
  • 1 x 300 L glass-lined reactor (r.t. to 200 °C)
  • 1 x 1000 L stainless steel low temperature reactor (N2 (l) cooling system)
  • 1 x 300 L stainless steel low temperature reactor (N2 (l) cooling system)
  • 1 x 200 L glass-lined reactor (-10 to 140 °C)
  • 1000 L Double-cone vacuum dryer (steam heated)
  • 2.5 m 3  Air-blower dryer with trays (steam heated)
  • 2 x Centrifuge (0.6 and 0.8 m diameter)
  • Delumper

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non-GMP CRO project intermediate manufacture
 

A newly leased facility situated at Qiandeng on the outskirts of Kunshan is fitted with the following equipment:

  • 1 x 2000 L glass-lined reactor
  • 1 x 1000 L glass-lined reactor
  • 2 x 500 L glass-lined reactor  
  • 2 x 300 L glass-lined reactor
  • 1 x 50 L Rotavap
  • 1 x 600 mm (inner diameter)  stainless steel centrifuge, PE lining
  • Vacuum tray dryer  
  • Utility 20 mmHg vacuum 
  • Soft-water system

 

 
 

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