An Overview of the FDA Approval Process

• The FDA approval process is a rigorous, multi-step procedure designed to ensure the safety and efficacy of new drugs before they reach the market. It involves various stages, including pre-clinical research, clinical trials, and a comprehensive FDA review.
• The review process involves a diverse team of FDA experts, including physicians, chemists, pharmacologists, and statisticians from the Center for Drug Evaluation and Research. They evaluate all submitted data, conduct inspections of clinical study sites, and compile an “action package” for final review by a senior FDA official.
• Even after a drug is approved, pharmaceutical companies may need to conduct additional studies or address outstanding issues. The FDA continues to monitor approved drugs for safety and effectiveness through post-market surveillance, ensuring ongoing protection of public health.

The FDA protects and promotes public health by regulating a wide variety of products, including pharmaceuticals. Receiving authorization from the FDA before releasing a product to the market is an ethical practice, and one which should be adhered to.

Oakwood Labs offers long-acting injectables and other sustained release microsphere technology, all in an aseptic, FDA-approved environment. Our manufacturing facility is equipped to conduct Phase I, II, or III clinical trial material, which can be of assistance for pharmaceutical companies seeking to go through the FDA approval process.

An Overview of the FDA Approval Timeline

To ensure that pharmaceuticals are both safe and effective, the FDA approval process is designed to favor products that abide by their requirements and processes alike.

Under a standard review, the FDA approval timeline will start approximately 10 months after an application is submitted. From here, the timeframe for approval of each product can differ.

Who Is Involved in the FDA Approval Process?

On the research side, a pharmaceutical company will oversee the discovery and development of the product, pre-clinical research, and clinical research of a new market product. They will need to completely fill out the New Drug Application before undergoing the FDA approval process.

The company will then submit any information collected from the laboratory in their NDA. Once submitted, physicians from the Center for Drug Evaluation and Research, chemists, pharmacologists, statisticians, and other scientists from the FDA will collectively work to determine if the drug is ready for approval.

Completing the “Action Package”

As mentioned above, the FDA only reviews completed New Drug Applications. If all data is present, the FDA approval timeline begins. First, the technical discipline teams address their respective sections and prepare for the supervisory review. Inspectors will then conduct inspections at locations where clinical studies took place. This ensures that findings were collected in an ethical manner without tampered evidence.

Data, evidence, and notes are organized by a project manager and complied into an “action package,” which becomes the basis for FDA review. A senior FDA official will then review all of the information and determine whether the drug is suited for its intended use.

How Does the Process Change if Approval Is Not Granted?

The FDA reserves the right to either delay or deny a product that has been submitted. Once this occurs, the pharmaceutical company who submitted will receive a letter that declares the news and offers an opportunity to meet with the FDA to discuss issues.

Delayed or denied applications may receive hearings, corrections for later approval, or even withdrawal of the application altogether. Common reasons for denial or delay include issues of safety, manufacturing, or effectiveness.

What Occurs After Approval?

It is normal for a pharmaceutical company to receive approval and still need to resolve issues or questions that were developed during the FDA approval timeline. Once they are able to produce the necessary studies and data, the New Drug Application is complete.

The FDA will then work with the company to research the prescribing information. The FDA approval process is often concluded with labeling, where the FDA works with the pharmaceutical company to define the best uses for the drug and discuss the terms on which the drug was approved.

Risk management for the drug is addressed and the company will seek best practices for monitoring health while the drug is utilized. These practices take time to ensure that the product is performing as promised. Products approved by the FDA are always subjected to post-market safety monitoring to confirm their impact on the population.

How Does This Impact the Public?

If the FDA deems a product ready for consumption by the public, it is designated as approved. Consumers can then identify whether products they research are FDA approved through two sites: Drugs@FDA and the “Orange Book.” Both of these destinations are regularly updated to keep customers aware of approved products and other relevant information.

Connect with Oakwood Labs as You Undergo the FDA Approval Process

FDA approval of a product gives users of the intended population confidence that the drug’s advantages outperform its known and potential dangers. Oakwood Labs provides the proper team and environment to help you every step of the way.

If you are looking for a team to support you through the FDA approval process or want to learn more, contact us today!

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?

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.

Aseptic Formulation: Key Takeaways

• Aseptic formulation is a critical process in pharmaceutical manufacturing that ensures drug products are free from contaminants, reducing the risk of infection for patients. It involves various techniques to prevent microbial contamination of drug components, containers, and excipients throughout the manufacturing process.
• Oakwood Labs operates an FDA-approved aseptic manufacturing facility with over 20 years of experience in developing and manufacturing sustained-release injectable drugs. Our facility includes cleanrooms with specialized equipment such as airflow hoods, isolators, and sterilizing fillers to maintain a sterile environment.
• As a full-service cGMP manufacturing facility, Oakwood Labs offers a range of services, including small-volume injectables, sterile liquids, lyophilized parenteral products, and microspheres. We handle various stages of clinical trial material production and commercial products for both human and veterinary use.

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 manufacturing

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.

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

• Small volume injectables
• Sterile liquids, sterile lyophilized parenteral, suspensions, microspheres, and more
• Class III and IV controlled substances
• Phase I, Phase II, or Phase III clinical trial material
• Commercial product for use in humans or for veterinary use

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.

At Oakwood Labs, we offer a variety of in-house analytical capabilities that support feasibility, formulation development, technology transfer, and GMP clinical and commercial manufacturing. To learn more about our analytical method development process and validation, continue reading.

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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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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.

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.

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.