Contract Manufacturing of Sterile Injectables

Contract Manufacturing of Sterile Injectables

commercial pharmaceutical development

In addition to Oakwood Labs primary business of long acting injectables, we also provide a secondary business to support contract manufacturing opportunities (CMO) for sterile injectable products. Oakwood currently has open capacity within our aseptic GMP facility to take on new projects.

Oakwood Labs has over 20 years of expertise in manufacturing sterile injectable products with proven in-house quality systems and an excellent regulatory track record. Oakwood currently manufactures five commercial products and has three pending approvals. Within our GMP-compliant aseptic facility, we can support clinical, registration, and commercial batches, along with in-house QC chemistry and QC microbiology expertise in method development, qualification, validation, and stability. Oakwood has the capability to manufacture aqueous, solvent-based, and suspension filled vials. We also manufacture high-potency and lyophilized products.

Read on to learn about the capabilities that we have for contract manufacturing of sterile injectables along with more information on our GMP commercial pharmaceutical manufacturing facility.

Oakwood’s GMP Aseptic Manufacturing Capabilities

We manufacture standard commercial injectables on a contract basis in partnership with other pharmaceutical companies. In the area of standard injectable products, we specialize in aseptic manufacturing, lyophilized products, and high potency compounds. Oakwood’s GMP capabilities are shown below. 

FDA Approved cGMP Aseptic Facility 

  • FDA approved cGMP aseptic facility for sterile injectables
  • Ability to support clinical, registration, and commercial batches
  • Perform short and long-term stability studies

In-house Expertise and Experience

  • QC Microbiology and QC Chemistry Laboratories
  • Robust quality systems
  • Method development, qualification, and validation support

Aseptic Fill and Finish Capabilities

  • Aqueous, solvent-based, and suspensions
  • Liquid and lyophilized presentations
  • Fill volume range: 1mL – 30mL
  • Vial size range: 2cc – 30cc

By offering these capabilities throughout our commercial injectable development process, we continue to provide value to each and every partner that we work with.

Competitive Advantages of Using Oakwood Labs as a CMO

Our competitive advantages include fast turnaround times, expertise on complex processes, ability to assist in technology transfer, providing transparent communication, and maintaining a high-level of FDA quality standards. 

Oakwood’s GMP Manufacturing Facility for Clinical and Commercial Injectable Pharmaceuticals

At Oakwood Labs, we are committed to maintaining an aseptic manufacturing facility that is FDA approved, and we continue to be a reliable provider for commercial contract manufacturing. Our facility includes the following features:

  • Microbiology and QC analytical laboratories
  • Raw material dispensing and weight
  • Equipment preparation and staging
  • Aseptic formulation and filling
  • Aseptic lyophilization
  • Vial capping
  • Inspecting, labeling and packaging
  • Shipping, receiving and warehouse space

Our aseptic manufacturing facility has its own building automation system as well as a nitrogen distribution system. Our facility is ISO classified and has WFI and Clean Compressed Air generation and distribution systems. We also utilize chemistry and microbiology labs, along with a temperature-controlled warehouse for the high-quality development of commercial injectables.

Ensure Quality with Our Commercial Injectables

We credit our proven history of compliance to our thorough, in-house quality systems. All of our commercial injectables and processes have to be verified through our quality control department and go through an extensive process.

Our commercial contract manufacturing process includes documentation control, internal audits, investigations and evaluations. This quality system ensures that all commercial injectables that are manufactured within our facility will remain safe, pure, and effective throughout the product lifecycle.

Contact Oakwood Labs for Contract Manufacturing

Do you have a contract manufacturing (CMO) project in need of clinical, registration, or commercial manufacturing services? Rely on Oakwood Labs to provide expertise, compliance, fast timelines, and high-quality manufacturing for your sterile injectable project. Reach out to Oakwood Labs today to learn more about our GMP aseptic facility and receive a detailed proposal with estimated timelines and costs. We look forward to helping you through our services.