Author Archives: Mark Ilhan

sterile injectablesOakwood 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!

Oakwood Labs has over twenty years of experience developing and manufacturing sustained release and targeted release injectable drugs. When it comes to our microsphere technology, we are a leading manufacturer for sustained release and controlled release pharmaceuticals.

Although these technologies are similar, there are some differences between controlled release and sustained release technologies. Learn more about controlled release vs. sustained release drugs below.

controlled release vs. sustained release

What Is Sustained Release Technology?

Sustained release technology is characterized by the slow releasing of a specific substance at a programmed rate to deliver the drug for a prolonged period of time. This type of technology is used for drugs that are metabolized too quickly and are eliminated from the body shortly after administration.

What Is Controlled Release Technology?

Controlled release technology is characterized by releasing drugs according to a predictable and rational programed rate to achieve the optimal serum-drug concentration. This dosage form enhances the safety, efficacy, reliability, and convenience of drug therapy.

Although this is a slow releasing system, unlike sustained release, this process is designed to produce predictable, constant concentrations of the drug. For this approach, the concentration of the active ingredient in the target tissue is controlled, not just the release of the drug.

Controlled Release vs. Sustained Release Technology

Sustained Release Drugs vs. Controlled Release Drugs: What’s the Difference?
Even though controlled release technology and sustained release technology are very similar, there are some distinctions to note between the two.

The key differences between controlled release and sustained release include:

  • Sustained release is a slow release of medication over a period of time, whereas control release releases medication over time in correlation with concentration.
  • Sustained release medication is offered solely by way of oral dosage, while controlled release can be via oral, transdermal administration, or other means.
  • Sustained release technology is first-order kinetic and controlled release technology is zero-order kinetic.

Advantages to Controlled Release and Sustained Release Technology

Controlled and sustained release can both be very beneficial. Some of these benefits include:

  • The frequency of drug administration is reduced
  • Patient compliance is improved, and drug administration is more convenient
  • There is better control of drug absorption and the total amount of a drug administered can be reduced
  • Side effects can be reduced
  • There is a minimization of fluctuations in plasma level

Also, controlled release and sustained release technology can be very effective as dosage forms. Oakwood Labs is a global leader in sustained release drug delivery and works to provide reliable and high-quality pharmaceuticals.

Choose Oakwood Labs for Your Controlled Release Technology

At Oakwood Labs, we have years of experience in developing and manufacturing sustained release drugs. Our microsphere technology can solve the most complex challenges and supports all phases of sustained release injectables.

We pride ourselves on our ability to achieve milestones within set deadlines, provide transparent communication, adapt to change, and offer our expertise throughout the entire process. 

Looking for a Partner in Sustained Release Technology? Contact Oakwood Labs Today

Oakwood Labs is your source for the development of microsphere products and sustained release drugs. Contact us today to learn more about the solutions we can provide for your company. We look forward to hearing from you.

Join Oakwood Labs for a complimentary webinar on August 24th, 2021 at 11 a.m. EST. This webinar will discuss a corporate overview and Oakwood’s approach to development of extended-release and long-acting injectables.

Oakwood’s capabilities include the following:

  • Pre-formulation development activities
  • Feasibility studies
  • Scale-up of formulation
  • Manufacturing toxicology batches
  • ICH compliant stability testing
  • Clinical trial manufacturing (Phase I, II, III)
  • Commercial aseptic GMP manufacturing

Reach Out to Oakwood Labs Today About Extended-Release Injectables

Contact us today to learn more about the extended-release solutions we can provide for your company. We look forward to hearing from you.

sustained release pharmaceuticals

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.

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sustained release drug delivery

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.

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