GMP Manufacturing

At Oakwood Labs, our FDA-approved cGMP manufacturing facility is capable of manufacturing Phase I, II, and III clinical materials, commercial products, and more. With a long history of compliance and decades of industry experience, Oakwood Labs is a reliable provider of pharmaceutical contract manufacturing services and more.

When you partner with our GMP manufacturing facility, you can expect short lead times, robust quality systems in place, and CMC development capabilities for a wide variety of products.

Key Features of Our cGMP Manufacturing Facility

Oakwood built and maintains an aseptic, FDA-approved manufacturing facility to enhance its partnering and development capabilities. The features of our GMP manufacturing 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 (learn more about the lyophilization process here)
• Vial capping
• Inspecting, labeling, and packaging
• Shipping, receiving, and warehouse space

Our Pharmaceutical Contract Manufacturing Capabilities

As a full-service cGMP manufacturing facility, we are able to offer our partners a range of contract manufacturing services. These services include:

• Small volume injectables
• Sterile liquids, sterile lyophilized parenteral, suspensions, microspheres, and others
• Class III and IV controlled substances
• Vials with lyophilized or plug stoppers, with both 13 mm and 20 mm openings
• Phase I, Phase II, or Phase III clinical trial material
• Commercial products 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. Our cGMP manufacturing facility is unable to manufacture cytotoxins, genotoxics, penicillins, or cephalasporins.

Additional Services We Offer

In addition to our GMP pharmaceutical manufacturing capabilities, we also offer a variety of additional services at Oakwood Labs. Some of the services we provide include:

• 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

Contact Oakwood Labs for GMP Pharmaceutical Manufacturing Today!

In need of pharmaceutical contract manufacturing services? Contact the team at Oakwood Labs today! We are ready to work with you!