Author Archives: Mark Ilhan

Since our founding in 1997, Oakwood Labs has stayed up to date on the advancements in pharmaceuticals and has remained an industry leader. Our team is continuously reaching new heights and is committed to growing every day. As part of these efforts, at Oakwood Labs we specialize in the lyophilization of pharmaceuticals.

What Are Lyophilized Pharmaceuticals and Why Are They Important?Lyophilized pharmaceuticals

The lyophilization of pharmaceuticals is a process used in the preservation of biomedical materials. Lyophilization, also known as freeze-drying, is the practice of removing water from a sample to stabilize a drug, vaccine, or biological sample without changing any characteristics of the product, allowing for preservation.

The three stages of the lyophilization of a product are:

  • Freezing – The sample becomes completely frozen in a freeze-drying chamber, removing water. The sample must be cooled below its critical temperature for it to become fully frozen.
  • Primary drying – The frozen material is dried through sublimation. The pressure of the chamber is reduced while temperature is raised slightly. Heat is added to provide energy in the sublimation process.
  • Secondary drying – This entails a desorption process where the remaining solvent is removed. Temperature is raised during this stage and pressure in the chamber is reduced.

After a product has gone through each phase successfully, lyophilization has taken place, and this process allows for products to be stored for a much longer period of time, and for the products to be shipped without harming the sample. After lyophilization occurs, the sample can then be reconstituted to its original form.

The Benefits of the Lyophilization of Pharmaceuticals

The lyophilization of pharmaceuticals has helped the medical industry reach new heights, particularly through the saving and transferring of samples which creates greater access to the product.

Additional benefits of lyophilized pharmaceuticals include:

  • Increase in shelf life of product
  • Easier to store the product
  • Enhanced stability of dry sample
  • No need for excessive heating of the product
  • Easier to ship the product
  • Less biohazard waste
  • Protects the sample from contamination

The lyophilization of pharmaceuticals has allowed for easier use and transferability of pharmaceuticals, pushing the industry forward. Due to its varied benefits, there will likely be continued growth in the use of lyophilization in pharmaceuticals for years to come.

The Future of Lyophilized Pharmaceuticals

It is clear that the use of lyophilization in the pharmaceutical industry will continue to grow. As drugs, vaccines, and other biomedical samples become more complex, the need for stability through lyophilization will only increase.

As biotechnology develops further, lyophilization will be able to support the growth of the industry and benefit new products being created. With lyophilization, products will continue to be more readily available and easily accessible. At Oakwood Labs, we focus on bringing you lyophilized pharmaceuticals that meet your project’s needs. 

Contact Oakwood Labs for More Information on Lyophilized Pharmaceuticals

Lyophilized pharmaceuticals are key in preserving samples for future use. Let Oakwood Labs provide the solutions for you. If you are interested in learning more about lyophilized pharmaceuticals, contact us today.

Our team of industry experts is committed to providing you with thorough information and answers to any questions you may have. We look forward to hearing from you.

Oakwood Labs has over 20 years of experience developing and manufacturing sustained-release injectable drugs. Our company built and maintains an aseptic, FDA-approved manufacturing facility to enhance development capabilities. This means that Oakwood Labs undergoes an aseptic formulation process prior to drug manufacturingaseptic formulation

Our team has the ability to achieve milestones within set deadlines, provide transparent communication, adapt to change, and offer expertise, all while ensuring proper sterilization throughout all of our processes. Read on to learn more.

What Is an Aseptic Formulation?

With pharmaceutical products, it is essential that they are sterile prior to introducing them to the patient. For drug products to be sterile, they must be manufactured using the aseptic processing technique.

Aseptic formulation refers to the various techniques used to ensure that the product is free of contaminants, ultimately reducing risk of infection for the patient. Drug components, drug product containers, and excipients are processed to prevent microbial contamination for the final sealed product.

For aseptic formulation, a major factor that is needed is a cleanroom. Cleanrooms contain airflow hoods, isolators, filling lines, sterilizing fillers, and various other equipment to ensure there is minimal introduction, generation, and retention of particles inside the room and other relevant parameters are controlled. Environmental monitoring is conducted to continually provide meaningful information regarding the quality of aseptic processing.

Why Is Aseptic Formulation Important?

When it comes to the medical and pharmaceutical industry, the biggest concern is the risk of infection to the patient. The safest way to prevent infection is to ensure that everything is as clean and sterile as possible. Aseptic formulation is designed to keep bacteria and other microorganisms out and prevent infection.

Our team at Oakwood Labs works diligently to keep our aseptic formulation process efficient, ensuring no risk to the patient.

About Our Aseptic Formulation Facility

At Oakwood Labs, we conduct the aseptic formulation process to reduce risk of infection to patients and keep our environments clean. As a specialty pharmaceutical company focused on the development and manufacturing of sustained release injectables, we are a fully aseptic cGMP manufacturing facility.

aseptic formulation

As a full-service cGMP manufacturing facility, we offer the following services:

In addition to our GMP pharmaceutical manufacturing capabilities, we have various other services. These include:

  • Formulation and analytical development
  • Accelerated and long-term studies
  • Scale-up, validation, or engineering batches
  • Complete method transfer and validation
  • Batch record and protocol development

Feel free to reach out to us regarding any questions on aseptic formulation and the processes at Oakwood Labs.

Contact Us to Partner with Our Aseptic Formulation Company

Interested in partnering with an aseptic formulation company? Contact Oakwood Labs today. We pride ourselves on having the experience to meet your requirements and expectations for microsphere-based sustained release pharmaceutical injectables.

Reach out to Oakwood Labs to learn more about our solutions and why partnering with us is beneficial.

microencapsulation technology

Microencapsulation is the process in which active substances are entrapped by extremely small capsules, which can contain a variety of substances such as solids, liquids, proteins, drugs, stem cells and more. The goal of cell microencapsulation has traditionally been drug delivery. The active molecules inside these capsules are protected until they reach their specific action site.

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Depot Injections

At Oakwood Labs, we are a leader in the manufacturing and development of sustained release pharmaceuticals, also known as depot injections. With over 20 years of expertise in depot drug development, our microsphere technology enables sustained release over durations of two weeks to one year.

Learn more about the depot drug manufacturing from Oakwood Labs.

Why Choose Depot Injections?

When it comes to depot injections, there are various advantages to receiving this form of medication. Some key reasons to consider depot drug development include:

  • Reduced number of injections needed – Due to the sustained release component, inconvenient and frequent injections are not needed.
  • Increase patient compliance – If you have difficulty remembering to take medication regularly or fail to receive injections, depot injections are a way to combat noncompliance.
  • Prevention of drug abuse – Depot drug injections reduce the possibility of using an excessive amount of a drug.
  • Targeting to specific areas – With this type of injection, higher drug concentration can be delivered to the targeted area.

Choose Our Depot Drug Manufacturing at Oakwood Labs

Oakwood labs has state-of-the-art technology to solve all of the challenges with developing and manufacturing pharmaceutical injectables. Our microsphere technology, Chroniject, is a patented, polymer-based injectable that is compatible with small molecules, hormones, peptides, and proteins. With our advanced technology, we have the ability to demonstrate lot-to-lot reproducibility and scale-up successes.

Some of the characteristics of why our technology stands out, include:

  • Fast development of formulations using small scale batches
  • Formulations are scalable
  • Controlled process parameters
  • Lot-to-lot reproducibility
  • Compatible with small molecules
  • Flexible release duration
  • Exceptional stability
  • Applications in multiple therapeutic indications

We understand that developing a depot injection requires high-quality manufacturing. The Oakwood Labs team is dedicated to achieving milestones within deadlines, providing transparent communication, adapting to change, and offering expertise through the entirety of the process.

Our Process for Formulating Microparticles in Depot Injections

When clients come to us for microparticle depot drug manufacturing, we start by determining the optimal product profile. We begin by optimizing the following:

  • Active pharmaceutical ingredient (API)
  • Duration of release
  • Particle size
  • Vial size
  • Needle size
  • Appropriate solvent system
  • Stable state levels
  • Method of administration
  • Drug load

After we optimize the product profile, we then begin to evaluate if the target product is compatible with our technology. The steps for this process include:

  • Pre-formulation activities – The result of these determines how we develop for batch production.
  • Manufacture and characterize feasibility formulations – The team will manufacture and characterize microsphere formulation pilot batches and vary formulation parameters if needed.
  • Finalize feasibility report and choose lead formulations for animal testing – The last step includes finalizing a feasibility summary report, recommending lead formulations for animal studies, and supplying material for initiating animal study.

With our advanced capabilities, you can rely on Oakwood Labs for your depot drug manufacturing. Throughout the entire manufacturing process, we are highly transparent with our clients, and all of our projects are agreed to by our clients beforehand.

Contact Us Today for Depot Drug Development Today

For over 20 years, our advanced technology and manufacturing capabilities have supported all phases of depot drug manufacturing and have solved complex challenges in the depot injection industry.

Contact us today to learn more about the solutions that Oakwood Labs can provide.

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

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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