Oakwood Labs has remained a reliable provider of pharmaceutical contract manufacturing services for more than twenty years. As a specialty pharmaceutical company, we are focused on the development and manufacture of sustained-release injectable pharmaceuticals through the use of our microsphere-based drug delivery technology.
Our team develops sterile injectables to provide enhanced therapeutic benefits to patients in addition to excellent returns to our pharmaceutical partners. Sterile injectables are used by a number of industries and are expected to be produced to standards of safety, purity, and quality. Learn more about sterile injectable development at Oakwood Labs below.
Features of Oakwood’s Facility for Manufacturing Sterile Injectables
In order to enhance our partnering and sterile injectable development capabilities, Oakwood Labs maintains an aseptic, FDA-approved, state-of-the-art cGMP manufacturing facility, ideal for manufacturing sterile injectables. This facility is equipped with the following beneficial features:
- Non-aseptic formulation
- Vial capping
- Compact and portable equipment train
- Aseptic filling
- Aseptic formulation
- Inspecting, labeling, and packaging
- Raw material dispensing and weighing
- Shipping, receiving, and warehouse space
- In-house QC Microbiology and QC Chemistry
- Equipment prep and staging
- Aseptic lyophilization
Our pristine full-service facility is just one of the many reasons that makes Oakwood Labs an effective partner. Since 1997, we have been achieving milestones within set deadlines, providing transparent communication, adapting to change, and offering our expertise throughout the process.
Choose Oakwood Labs for Your Sterile Injectable Needs
Oakwood Labs has been an effective partner to a great deal of pharmaceutical firms of various sizes across the globe. When you choose to partner with our GMP manufacturing facility, you are guaranteed to receive short lead times, robust quality systems, and CMC development capabilities for a broad range of sterile injectables and assorted products.
Oakwood Labs is fiercely committed to quality and has had a long history of compliance. Our Quality System ensures that sterile injectables manufactured at our facility comply with specified requirements and are safe, pure, and effective throughout the entirety of the product lifecycle.
When it comes to manufacturing sterile injectables, there is no better choice than Oakwood Labs. Choose us to be your reliable and dedicated partner.
Oakwood Labs Offers Pharmaceutical Contract Manufacturing Capabilities and Other Services
At Oakwood Labs, we support all phases of long-acting injectable (LAI) development. We pride ourselves on being a full-service cGMP manufacturing facility capable of providing services to our partners. The range of manufacturing services we offer includes:
- Small-volume sterile injectables
- Sterile liquids, sterile lyophilized parenteral, suspensions, microspheres, and more
- Class III and IV controlled substances
- Vials with lyophilized or plug stoppers (13mm and 20mm openings)
- Phase I, Phase II, or Phase III clinical trial material
- Commercial product to be utilized in humans or for veterinary use
In addition to the variety of GMP pharmaceutical manufacturing capabilities, Oakwood Labs also supplies other services including the following:
- 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
Not sure which of our services is best suited for your industry needs? Reach out to our team of experts today!
Contact Oakwood Labs to Learn More Our Sterile Injectable Development
Are you looking for sterile injectables from a reliable company with decades of experience? Oakwood Labs has the solutions for you. Our team will work closely with you through proof of concept, feasibility studies, clinical trial material, and, ultimately, FDA-approved commercial supply.
Questions on our sterile injectable development? Contact Oakwood Labs today to learn more about how we can help. We look forward to assisting you!
Since 1997, Oakwood Labs has remained a global industry leader in sustained release pharmaceutical development and technology, and our team is committed to offering contract development and manufacturing services to the pharmaceutical industry on a global scale. Continue reading to learn more about our sustained release technology and the many ways it is beneficial in pharmaceuticals.
Oakwood Labs is a leading company in the development and manufacture of sustained release pharmaceutical products, specifically microparticles for injection. We specialize in developing microparticle drug delivery formulations with in vivo release durations ranging from one week to one year. To learn more about our process for formulation, keep reading.
Oakwood Labs has been working as a contract development and manufacturing company, or CDMO, for over twenty years, and we have remained a leader in the pharmaceutical industry in this time.
With our microsphere-based drug delivery technology and our cGMP manufacturing facility, we are equipped to provide services from initial feasibility through commercial projection. Our technology allows for ease of scale-up throughout development without impacting finished product results. We can customize release durations from weeks up to one year.