GMP Manufacturing

Process development

GMP certification

Regulatory supporting

data

Analytical development

Your innovation

Manufacturing

 

To date many Life Science innovators  have selected Syntagon for their GMP manufacturing. We offer both speed of delivery as well as capacity to address the most complex syntheses by combining reactor technology for modern synthesis with purification techniques such as preparative HPLC. In summary our GMP plant is perfectly adapted for supply of clinical trials material and low volume manufacturing (< 1MT per annum).

 

Preparative scale HPLC

In 2008 we had our first preparative HPLC system up and running.  Today three such unit (Novasep and Varian) are operational. These are equipped with 15 cm diameter columns working up 1.5 L/min flow rates and up to 100 bar pressure.  Purification of complex reaction mixtures, resolution of enantiomers and fractionation of natural products are examples of what we typically use these systems for.  Normally, 1 kg per day can be purified, making these systems suitable for clinical supply and low volume manufacturing (<500 kg annually).

 

Chem Reactors

Our reactors range from 30 L up to 800 L  (glass lined and stainless steel, 316L).  Each reactor is equipped with a stand-alone Huber heating/cooling unit offering a temperature range between -50 C and +170 degrees.  This means that we can handle a wide range of reaction types including  low temperature chemistry such as BuLi type and high temperature rearrangements.  Some reactors and filter dryers are equipped with split butterfly valve (PSL) charging technology allowing for contained charges / discharge.

 

Four categories of pharmaceutical ingredients are currently developed and manufactured at Syntagon:

 

Novel excipients

A custom manufactured life science ingredient involving chemical reactions on 250 L scale followed by purification using preparative HPLC.  The manufacturing process is fully validated and capable of producing up to 500 kg annually.

 

Adjuvant ingredient

A custom manufactured life science ingredient involving preparative HPLC for fractionation of natural products containing sapponines.

 

Cross linker

By a combination of purification techniques including short path distillation a life science ingredient of uniquely high quality is obtained.  The manufacturing process is validated. This product

 

Clinical API’s

We typically deliver 3-5 different clinical API’s each year including supporting documentation for regulatory filing (IMPD/IND CMC section 2S).

 

 

Reactors

 

  •  800 liter QVF/DeDietrich glass-lined reactor. Heating/cooling unit Huber unistat 645w. Temperature interval: -40°C – 200°C
  •  250 liter Buchi glass-lined reactor. Heating/cooling unit Huber unistat 166w. Temperature interval: -50°C – 200°C
  •  50 liter Buchi glass-lined reactor. Heating/cooling unit Huber unistat 164w. Temperature interval: -50°C – 200°C
  •  50 liter Buchi glass-lined reactor. Heating/cooling unit Huber 140w HT. Temperature interval: -50°C – 200°C

 

Pressure reactors

 

  • 100 liter Buchi pressure reactor. Max pressure: 10 bar
  • 20 liter Buchi pressure reactor.  Max pressure: 10 bar
  • 3 liter Buchi pressure reactor. Max pressure: 6 bar

 

Distillation equipment

 

  • 2x VTA short-path evaporator. Operating pressure: atmosphere to 0.001 mbar Working temperature: max 300 °C (evaporator). Throughput 0.1 to 2 L per hour

 

Preparative HPLC systems

 

  • Hipersep Lab II with UV/VIS detector and automated fraction collector. Binary gradient up to 1.5 L/min. Standard Column: Novasep DAC/SAC Columns; i.d 50 and 150, length 50 to 400 mm. NEW 2015
  • Hipersep Lab II with UV/VIS detector and automated fraction collector. Binary gradient up to 1.5 L/min. Standard Column: ProChrom DAC Column, i.d 150 mm, bed length up to 400 mm.
  • Varian SD-2 Varian UV with UV-Vis and ELSD detectors. Binary gradient up to 1.2 L/min. Standard Columns: Varian DAC/SAC columns; i.d. 50 and 150, length 50 to 400 mm.

 

Nutsche filters

 

  • 30 liter Aurora filter (model A20-S) equipped with PSL charging point with split butterfly valve.
  • 2×30 liter stainless steel nutsche filter and 10 liter PTFE coated stainless steel nutsche filter
  • 150 liter stainless steel nutsche filter

Dryers

 

  • Vacuum tray dryer Italvacuum 500 L
  • Vacuum tray dryer Binder 115 L
  • Vacuum tray dryer Binder Mod. 53 L
  • Vacuum Tray Dryer SPT-200. 50 L

 

Miscellaneous

 

  • Quadro Comil U5 milling equipment
  • Glove Box's for contained handling of highly potent compounds

Manufacturing Equipment

Phone: +46 8 554 422 50

email: info@syntagon.se

 

 

Sweden

 

Postal address

Syntagon AB

Box 2073

SE-151 02 Södertälje

Sweden

 

Visiting & Delivery address

Tallvägen 6

SE-151 38 Södertälje

Sweden

Latvia

 

Phone: +371 67 490 881

email: info@syntagon.se

 

 

Postal and Visiting address

Syntagon Baltic SIA

Vecpagrabs Pinki Babites pagasts

LV-2107 Babites novads

Latvia