GMP Manufacturing

Oakwood Labs houses an FDA approved cGMP manufacturing facility, for supply of Phase I, II, and III clinical material and commercial product. Oakwood has a long history of compliance, unparalleled expertise and decades of experience, CMC development capabilities for a wide variety of products, robust Quality systems in place, short lead times and superior management.


Facility Features

Oakwood built and maintains an aseptic, FDA approved manufacturing facility to enhance its partnering and development capabilities. The features of the facility include:

  • In-house QC Microbiology and QC Chemistry
  • Raw material dispensing and weighing
  • Non-aseptic formulation
  • Equipment preparation and staging
  • Compact and portable equipment train
  • Aseptic formulation
  • Aseptic filling
  • Aseptic lyophilization
  • Vial capping
  • Inspecting, labeling and packaging
  • Shipping, receiving, and warehouse space

Capabilities

  • Small volume injectables
  • Sterile liquids, sterile lyophilized parenteral, suspensions, microspheres, and others
  • Class III and IV controlled substances
  • Vials with lyophilized or plug stoppers, both 13mm and 20mm openings
  • Phase I, Phase II, or Phase III clinical trial material
  • Commercial product for use in humans or for veterinary use

Capacity and Constraints

Oakwood currently fills 2cc – 30cc (13mm or 20mm) vials. Maximum batch sizes vary from 1,000 – 20,000 vials per batch, while the lyophilizer capacity is between 1,000 – 40,000 vials. Oakwood is unable to manufacture cytotoxins, genotoxics, penicillins or cephalasporins.


Additional Services

  • Formulation and analytical development activities
  • Accelerated and long-term stability studies
  • Scale-up, validation, or engineering batches
  • Complete method transfer and validation
  • Batch record and protocol development