GMP Aseptic Manufacturing

GMP Aseptic Manufacturing

PLGA microspheresWhen the formulation has been scaled up successfully and is ready for a Phase 1 or 2 clinical batch for human testing we perform a seamless technology transfer of the formulation process and analytical methods from our R&D labs to our GMP manufacturing facility.

GMP Facility for Clinical Trial Material

Typically Oakwood manufactures an engineering batch to confirm the process before producing our clinical material. Oakwood has extensive experience in manufacturing global clinical trial material of microsphere-based pharmaceutical products, for Phase 1, 2, and 3 clinical trials. Our aseptic GMP facility was designed specifically to accommodate the manufacture of this type of product. In addition we offer full characterization capabilities through our Microbiology and Chemistry groups, proper documentation of batch release, and accelerated and long term stability studies.

As we progress later in development and nearing a Phase 3 clinical batch the process will have been validated. This includes determining specifications for key process parameters. For Phase 3 trials, multiple lots of API and polymer are utilized in order to demonstrate that product, made within the range of the polymer specifications, is safe and efficacious. All analytical methods for raw material and finished product will be validated at this point. We generally recommend that Phase 3 clinical trial material be produced at the same scale as the planned commercial scale, to avoid potential delays in commercializing the product should the clinical trials be successful. When it comes to manufacturing complex sustained release microspheres, expertise and experience are crucial to overcome the many challenges involved.

GMP Manufacturing Facility for Long Acting Injectables

At Oakwood Labs, our FDA-approved cGMP manufacturing facility is capable of manufacturing Phase 1, 2, and 3 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
  • Vial capping
  • Inspecting, labeling, and packaging
  • Shipping, receiving, and warehouse space

Our Pharmaceutical Manufacturing Capabilities

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

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 – 50,000 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!

Additional Resources on Clinical Trials