Facilities and Equipment

Auritec's laboratories are housed in Pasadena, a 3,000 sqft manufacturing facility, for drug delivery. Auritec has access to Spectroscopy, Chromatography, Electrochemistry, Microscopy, and Laser Laboratory equipment. The large, central laboratory spaces include a wet-lab and primary research areas. The purpose of this facility is to scale intravaginal ring production from laboratory prototypes to small-scale manufacture.  This facility has been fully functional since March 2012. 

Capabilities of the facility include: 

Core production (tableting): GlobePharma MTCM-1 manual tablet compression machine for initial formulation development using identical B tooling to that in the production tablet presses; Riva Single-station Minipress 6-ton tablet press with B tooling for core production at up to 6000 cores h-1. We also own a co-extruder manufactured by Randcastle.

Pod production (core coating): Vector MFL.01 Micro fluid-bed spray coater for PLA and PVA coating of cores in batches of 20-600 g (1000-30,000 cores) in Würster mode and 100-600 g (5,000 – 30,000 cores) in top-spray mode; dedicated curing oven. We also have an Ethylene Oxide Sterlization System (Anderson Sterilizers) for coating drug particles.

Injection molding: Custom laboratory-scale liquid silicone resin (LSR) injection molding system including single-cavity molds for production of R&D lots of silicone ring blanks for human and sheep, macaque, and in vitro studies. Morgan Press G-55T thermoplastic injection molding system for R&D and short-run production of thermoplastic ring blanks (EVA and polyurethane – alternative materials to LSR).

Assembly: Class 100,000 clean-room (175 ft2) with workbenches for manual IVR assembly and packaging; adhesive dispensing system for semi-automated silicone backfilling during assembly (barrel loader manufactured by JA Crawford); 5x-50x inspection microscope.

Analytical and QA/QC: USP Type II dissolution apparatus (6 systems) manufactured by VanKel and Distek; Shaking incubators (Forma/Thermo); Zymark Multidose G3 autosampler; digital microscope; custom low-volume flow-through dissolution apparatus for IVR release evaluation; Complete analytical facilities, including HPLC, HPLC-MS, and HPLC-MS/MS; GC-MS; spectroscopy (Spectronic 1201 UV/Vis spectrophotometer; HP UV/Vis spectrophotometer); particle size analysis light scattering (Coulter); fluorescence microscopy; laminar flow hood; Carver press; centrifuge; lab oven and refrigerator; Harvard Navicyte 6 cell vertical Ussing chamber; Perkins – Elmer CSC-2 Differential Scanning Calorimeter.

The wet-lab and microbiology resources include four chemical fume hoods, two level 3 biosafety laminar-flow hoods, recirculating chilled water supply, on-line deionized water system (1MW and >18 MW), vacuum lines, inert atmosphere glovebox with recirculating purifier, refrigeration and freezing (4°C, 0°C, -20°C, -30°C, -80°C), autoclave, incubators, liquid nitrogen supply, system air compression, 3 analytical balance instruments, moisture balance and compact dot matrix printer, temperature/humidity stability chamber, electric mixers, fridge alarm systems and centrifungal rotor mills. The Instrumentation Facility and Laser Laboratory are in dedicated spaces separated from the open-plan wet lab.

Computer: All scientists and staff have access to a personal computer. All end-user computers are equipped with Microsoft Office, email, anti-virus, and Internet software.

Office: Auritec Business Office is located at 3200 Santa Monica Blvd., Santa Monica, CA 90404. Auritec Pharmaceuticals also maintains an office in Pasadena equipped with standard office equipment and furnishings.