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Facilities
SPK has five process R&D laboratories, one analytical AR&D/QC laboratory, a kilogram
scale development laboratory to handle the early stages of process scale-up as well as producing kilogram-scale materials, and a manufacturing facility in Taicang, Jiangsu Province equipped with reactors ranging from 200-3000 L. This
facility has been used for the manufacture of key intermediates
for ScinoPharm Taiwan's generic APIs. |
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Process R&D laboratories
Our approximately 25 strong process R&D (PRD) staff work in five dedicated process laboratories equipped with standard laboratory equipment including staff operated HPLCs (Agilent 1100/1200 VWD). Via our ARD
(analytical research and development) laboratory,
our PRD staff have access to chiral HPLC, achiral/chiral GC,
GCMS (Agilent), LCMS (Agilent), polarimetery, FTIR, Karl Fisher titration, UV-Vis, stability Chamber, LOD, and ROI analysis, which are all
operated by ARD staff with proper quality control. Our ARD staff also conduct chiral and achiral
HPLC and GC analytical method development. DSC/TGA/X-Ray (single crystal/powder diffraction) analysis is conducted at ScinoPharm Taiwan or the Shanghai Institute of Organic Chemistry (SIOC).
Reactions are conducted at scales between 5 mL and 20 L. Our
PRD staff are led by experienced group leaders and
managers. Each group leader is responsible for one R&D laboratory.
In process R&D we develop free-to-operate generic API processes followed
by technology transfer to
our Taiwan parent (SPT) for cGMP production. We also develop
free-to-operate processes for API intermediates as well as key intermediate scale-up development for CRO customers (via ScinoPharm Taiwan). We have more than 7 patents pending as a result of our process development projects 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 laboratories
In our analytical R&D
laboratory we conduct instrument qualification and calibration, analytical method development and validation. We set up raw material specifications, in process control
methods, product specifications and conduct product stability studies. The following equipment is utilized by this department:
- LCMS (Agilent 6120, single quadrapole, ESI)
- GCMS (Agilent 7890A GC/5975C MSD)
- 2 x Agilent 1100 HPLC (2xDAD; 1xRID)
- 5 X Agilent 1200 HPLC (VWD)
- Agilent 1200 HPLC (DAD)
- Shimadzu GC-2010 AF GC with TurboMatri x 16 Headspace sampler
- Agilent 7890 FID/ECD GC with Agilent 70 Headspace sampler
- 2 x Agilent 6890 FID GC
- Audolph Autopol III polarimeter
- Nicolet FTIR Avator 360
- Metrohm 831 Karl Fisher titrator
- Mettler Toledo DL32 Karl Fisher titrator
- Mettler Toledo HG 63 Halogen moisture analyzer
- Metrohm 794 Auto-titrator
- Agilent 8453 UV-Vis Spectrophotometer
- GIANT stability chamber
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Kilo laboratory
Our Kilo laboratory is used for both first stage scale-up as well as production of kilogram quantities of materials. The laboratory is equipped with:
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- 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
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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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API key intermediate manufacturing
plant
A leased production facility,
fitted with reactors, a control room and a QC
laboratory and about 400 square meter of warehouse 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 API key intermediates. These intermediates are then used by ScinoPharm Taiwan as starting materials for
the GMP production of APIs. The facility is equipped with
more than 25 reactors with a total reactor volume of
more than 31 m3. The configuration allows
more than three concurrent production lines. IPC (in process control) utilizes dedicated Agilent 1100 HPLCs and Agilent 4890 GCs.
- 2 x 3000 L glass-lined (0 to 200 °C)
- 7 x 2000 L glass-lined (0 to 200 °C)
- 4 x 1000 L glass-lined/stainless steel reactor (0 to 200°C)
- 2 x 1000 L stainless steel low temperature reactor (N2 (l) cooling system)
- 3 x 500 L glass-lined/stainless steel reactor (0 to 200 °C)
- 1 x 300 L glass-lined reactor (r.t. to 200 °C)
- 1 x 500 L glass-lined reactor (r.t. to 200 °C; electric heated)
- 1 x 300 L glass-lined reactor (r.t. to 200 °C; electric heated)
- 1 x 200 L glass-lined reactor (0 to 200 °C)
- 1 x 1000 L Double-cone vacuum dryer (G/L)
- 1 x 1000 L Double-cone vacuum dryer (stainless steel)
- 1 x 2.5 m 3 Air-blower dryer with trays (steam heated)
- 1 x 48 trays vacuum dryer (steam heated)
- 2 x Centrifuge (0.6 and 0.8 m diameter)
- 2 x Centrifuge (1.0 m diameter)
- 2 x Pulverizer (stainless steel)
- 2 x stainless steel chromatography columns (20 cm ID x 2 m length)
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Quality Control
and Quality Assurance (QC and QA)
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| In our QC department we conduct material qualification and in-process control to ensure our manufactured products meet the required specification. QA conduct staff training, document control, and batch release. Our quality system is GMP appropriate and we follow SOPs, and produce Production Batch Records, training records, cleaning records, maintenance records, change control and deviation reports.
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