Our Facility

PharmAgra Labs, Inc. is a privately held company that for almost twenty years has been providing contract R&D in organic and medicinal chemistry.

Our operations began in 1999 with the renovation of leased “flex-space” in Arden, NC. After a few years of rapid growth, we became eager to design and own a larger facility.
We realized our objective in 2002, when PharmAgra Labs purchased, renovated and equipped an 11,400-square-foot facility in Brevard, NC. The result is a state-of-the-art laboratory specifically designed for the unique requirements of synthetic organic chemistry.

In 2007, we constructed a cGMP laboratory for the preparation of clinical trial materials and commercial APIs. We began the development of our first product immediately thereafter. In July of 2009 we successfully completed our first FDA pre-approval inspection (PAI) with no 483s issued.

Our site is easily accessible to clients via the Asheville, NC and Greenville/Spartanburg, SC regional airports as well as the Charlotte International airport. For directions, click here.

Some highlights of our facility:

  • Company-owned site on 3.5 acres
  • 11,400-square-foot building
  • Class 100,000 cGMP suite
  • Safe/compliant/exceeds codes
  • Fully sprinkled

Site security includes:

  • Burglar alarm system
  • Fire alarm system
  • Fenced/gated/restricted access

Click on the grey bars below for full information of our facility:

The center of activity at PharmAgra is the research laboratory, a 4,000-square-foot lab containing 26 fume hoods divided into four work areas. For easy access, common analytical equipment is located on the counters at the rear of the laboratory. The easily accessible analytical lab and flammable solvent storage room help create a spatially optimized work environment with all distances minimized.

The laboratory is separated from the office area by a storefront glass wall that not only allows for diffusion of natural light into the lab area, but also serves to increase visibility for safety purposes. To facilitate communication, chemists’ desks are located in the office area across from their group leader.

The research lab features:

  • 4,000 square feet
  • 22 bench hoods
  • 4 walk-in hoods

The kilo lab is designed for safe execution of larger-scale reactions. The room is separated from the rest of the building by 2-hour firewalls and, like the rest of the facility, is protected by a sprinkler system. The lab is equipped with a 180-square-foot reactor booth (dedicated dry chemical fire-suppression system) and a 12-foot walk-in hood. The reactor booth allows for large portable equipment (reactors, work-up stations, centrifuge, etc.) to be rolled in as needed.

Features of the kilo lab include:

  • 750 square feet
  • 12-foot walk-in hood
  • 10′ x 18′ reactor booth featuring:
  • Dedicated dry chemical fire suppression
  • 7500 CFM ventilation
  • Reactors and work-up stations to 72L
  • 10L Rotary evaporator
  • 20L Rotary evaporator
  • Parr hydrogenator to 2.5L
  • Parr pressure reactor 19L/2,000 psi
  • Ozone generator
  • (2) Kugelrohr distillation apparatus
  • Fractional distillation equipment
  • (2) 12L spinning band stills (30 theoretical plates)
  • Prep MPLC systems (up to 24L silica at 600 mL/min)
  • Wiped-Film Evaporator (0.06m2, 0.04-5 Kg/hr)
  • Centrifuge (14″, 7L, 2500G)
  • Sprinkler system
  • Ultrapure water system
  • Isolation by 2-hour firewalls and doors

In 2007, we constructed a cGMP laboratory for the preparation of clinical trial materials and commercial APIs. In July of 2009 we successfully completed our first FDA pre-approval inspection (PAI) with no 483s issued.

Some features of the lab include:

  • All air HEPA filtered
  • Class 100,000 laboratory and access/egress rooms
  • Class 10,000 packaging room
  • All rooms differential pressure controlled
  • Door magnetic interlocks on all access/egress rooms
  • ~1000 sq ft
  • 4 Bench Hoods, 1 Walk-in
  • 2 gowning rooms
  • Raw materials staging/glassware washing room
  • Dedicated, segregated GMP warehouse area

An easily accessible but protected analytical lab is located adjacent to the research laboratory. This area is used for cGMP analyses (validated instruments) as well as more sensitive instrumentation (NMR, LC/MS, etc.). More common analytical instruments are conveniently located at the rear of the research laboratory.

Some features of the analytical lab include:

  • 600 square feet
  • NMR, 400 MHz (1H, 13C, 19F, 31P)
  • LC/MS (APCi, ESI)
  • GCs (MSD, FID)
  • LCs (UV, DAD, ELSD, MS)
  • FT-IR
  • Karl Fischer titrator
  • pH meter

The flammable liquids bulk storage area is located a short distance from the rear of the research laboratory. This provides our chemists with ready, safe access to bulk solvents and to temporary hazardous waste storage.

Features of the flammable liquids room include:

  • 300 square feet
  • Continuous ventilation
  • 2-hour fire separation
  • Dry chemical fire suppression
  • Secondary spill containment
  • Earth grounding/bonding for containers
  • Explosion-proof refrigerator
  • Fire-rated cabinets with secondary containment for hazardous waste