FACILITIES

Alphora operates a 74,000+ ft² FDA inspected facility, centrally located within the North American Pharmaceutical Industry and in close proximity to several technically focused universities. Our operation includes:

 

 

 

 

 

  • Synthetic Organic Laboratories

  • cGMP Analytical Laboratories

  • cGMP Kilo Laboratories

  • cGMP Manufacturing Plant

  • cGMP Warehouse

  • cGMP Stability Chambers

  • non-GMP and cGMP High Potency 

 

Alphora’s cGMP Kilo Laboratories and Manufacturing Plant operate with temperature ranges of cryogenic (-80ºC) to 200ºC with pressure rated vessels for hydrogenations and other pressurized transformations. Alphora provides a full range of API Technology development services for the IND enabling, phase II and III and commercialization stages, and can supply API quantities for clinical and niche commercial requirements.

 

  • MultiMax™ - Automated process development and calorimetry tool

  • HEL Thermal Screening Unit

  • HEL Reaction Calorimetry Unit

  • LC/MS: Agilent 1200 HPLC interfaced with Agilent XCT Ultra ion trap (high sensitivity trap capable of performing multiple MS/MS stages)

  • 3 Waters 2695 HPLC's with diode array, variable wavelength detection

  • Isolators for synthetic and analytical work with high-potency compounds

 

EQUIPMENT

 

Synthetic and
Process Chemistry:

  • Jacketed vessels 5L - 30L

  • 0.5L to 4L Parr Hydrogenators

  • Over 100 linear feet of fume hood space

  • 300 MHZ Bruker NMR with broadband probe 

     

  • SD-2 Varian Prep HPLC, 200ml/min

  • 75M Flash Biotage LC

  • Isolera-1 Biotage LC

  • 6"x 4ft static chromatography columns

  • DoE software - Modde™, JMP™, Design Expert™ and DynoChem™

ANALYTICAL EQUIPMENT

  • 7 Waters Acuity UPLC's with diode array detection

  • 1 Waters H-Class UPLC QbD Method Development System (Fusion Software)

  • 9 Agilent 1100/1200 HPLC's with diode array and/or RI and/or QDa detection

  • 5 Agilent 1200 Rapid Resolution LC's with diode array detection

  • 3 Waters 2695 HPLC's with diode array and/or ELSD detection

  • 6 Agilent 6890N/7890 GC's with FID and/or TCD and /or ECD detection, 3 with HeadspaceAuto-samplers

  • 1 Agilent 7890/5975 GC/MS System

  • 1 Dionex ICS 3000 Ion Chromatograph (both Anion and Cation)

  • 1 Bruker microTOF focus LCMS (Accurate mass capability) - GMP

  • 1 Agilent 7700x ICP-MS equipped with Microwave Digestion

  • UV Spectrophotometer

  • Polarimeter

  • Volumetric and Coulometric Karl Fischer Titrators

  • Multi-purpose potentiometric titrator

  • TA Instruments Q200 DSC System

  • TA Instruments Q5000 TGA System

  • PE Spectrum Two IR Unit

  • Single Crystal and Powder X-ray Diffraction available through local contractors under CDA/MSA

  • Isolators for synthetic and analytical work with high-potent compounds

 
 

cGMP SCALE-UP

Kilo Laboratories

  • 2 Kilo Laboratories: Walk-in 12ft x 8ft fume hood within separate room with air lock entry

  • 1 Kilo Laboratory: Walk-in 5ft x 3ft fume hood within separate room with air lock entry

  • 1 Kilo Laboratory for high potency process work (Safebridge level 4 capabilities for compounds with OEL's < 30ng/m3): Walk-in 12ft x 8ft fume hood within separate room with air lock entry complete with isolators and class 100,000 HEPA filtration design

  • 20L and 2 x 60L Buchi Glass Lined reactors -80 to 200°C

  • 2- 20L Glass reactors -30 to 150°C

  • 4L and 20L Parr Pressure Reactor, hydrogenation & pressure capability to 1000 psi

  • 20L Rotary Evaporator

  • Associated reaction glassware, addition and work up equipment

Manufacturing Plant

  • 200L Glass Lined Reactor, -80 to 200°C, hydrogenation & pressure capability to 150 psi

  • 500L Glass Lined Reactor, -30 to 200°C, hydrogenation & pressure capability to 150 psi

  • 2 x 50L Glass Reactors -30 to 150°C

 

Chromatography Separation Equipment

  • 150M Biotage Flash Chromatography System

  • 400L (40kg) Biotage Flash Chromatography System

  • 2” and 4” Load & LockTM Agilent Prep LC columns