Contract Manufacturing for Commercial Long-Acting Injectables
Contract Manufacturing for Commercial Long-Acting Injectables
Contract Manufacturing for Sterile Injectables
Oakwood Labs offers comprehensive GMP contract manufacturing services for sterile injectable products, combining over 25 years of industry expertise with an outstanding regulatory track record. We support pharmaceutical and biotech companies in commercial product development, technology transfer, and full-scale manufacturing, providing reliable, high-quality solutions from clinical trials to commercial launch.
Our GMP Contract Manufacturing Services at a Glance
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Experienced Team: Our sterile injectable manufacturing experts deliver fast turnaround times, guidance on complex processes, and transparent communication throughout every stage of development.
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End-to-End Capabilities: Oakwood Labs offers in-house QC microbiology and chemistry laboratories, method development, qualification, validation, and stability studies to ensure products meet rigorous FDA standards.
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Versatile Manufacturing: We can produce aqueous, solvent-based, and suspension-filled vials, including high-potency and lyophilized products, supporting clinical, registration, and commercial batches.
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Capacity for New Projects: In addition to our primary focus on long-acting injectables, Oakwood maintains open capacity in our aseptic GMP facility to accommodate contract manufacturing opportunities (CMO) for sterile injectable products.
Oakwood Labs currently manufactures five commercial products and has three pending approvals, demonstrating our proven capabilities in delivering high-quality sterile injectables. With decades of experience, a fully compliant GMP facility, and robust quality systems, we are equipped to support your program from formulation through commercial production.
To learn more about our contract manufacturing capabilities and how Oakwood can support your next project, explore our GMP Manufacturing Services page.
Oakwood’s GMP Aseptic Manufacturing Capabilities
Our FDA-compliant GMP capabilities provide full support across all stages of production, from clinical batches to commercial-scale manufacturing, backed by robust quality systems and experienced teams.
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 fill and finish capabilities and our expertise throughout our commercial injectable development process, we continue to provide value to each and every partner that we work with.
Why Choose Oakwood Labs as Your CMO Partner
Oakwood Labs offers a range of competitive advantages that make us a trusted partner for pharmaceutical companies:
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Fast Turnaround Times: We prioritize efficiency to keep your projects on schedule without compromising quality.
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Expertise in Complex Processes: Our team has extensive experience handling challenging formulations, including high-potency, lyophilized, and long-acting injectables.
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Seamless Technology Transfer: We support smooth knowledge transfer and scale-up from your lab to commercial manufacturing.
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Transparent Communication: Our collaborative approach ensures you are informed and involved at every stage.
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Rigorous FDA Compliance: All projects are executed under strict GMP standards, backed by proven quality systems and regulatory expertise.
By combining scientific expertise, operational excellence, and a commitment to quality, Oakwood Labs delivers reliable, efficient, and compliant contract manufacturing solutions for your injectable products.
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.