Contract Manufacturing

Oakwood Labs has a cGMP facility, FDA approved for commercial manufacturing of sterile injectables and is now capable of partnering with pharmaceutical companies in need of a supplier. 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.

Oakwood Labs sterile injectable manufacturing facilityOverview

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

  •  Oakwood Labs Contract Manufacturing - Formulationmicrobiology and QC analytical laboratories
  • raw material dispensing and weighing
  • non-aseptic formulation
  • equipment preparation and staging
  • aseptic formulation
  • aseptic filling
  • aseptic lyophilization
  • vial capping
  • inspecting, labeling and packaging
  • shipping, receiving and warehouse space

 Capacity and Constraints

Oakwood currently fills 2cc – 50cc (13mm or 20mm) vials. Maximum batch sizes vary from 10,00040,000 vials per batch, while the lyophilizer capacity is between 6,00040,000 vials.

Oakwood is unable to manufacture cytotoxins, genotoxics, penicillins or cephalasporins, or certain antibiotics.

Capabilities

Our facility is designed to be compatible with the following:

  • small volume injectables
  • liquids, lyophilized, suspensions, sterile liquid or lyophilized parenterals, microsphere products, and others
  • Class III and IV controlled substances
  • vials with plug or lyophilized stopper
  • products requiring an aseptic filling process
  • Phase I, Phase II, or Phase III clinical trial material
  • commercial product for use in humans and for veterinary use

 Additional Services

  • formulation and analytical development activities
  • complete method transfer and validation
  • batch record and protocol development
  • scale-up, validation or engineering batches
  • further raw materials studies
  • accelerated and long-term stability studies