At Oakwood Labs, we are known for our industry-leading pharmaceutical research and development. This includes everything from the first stages of initial research to final production. Our FDA-approved cGMP manufacturing facility is capable of aseptically manufacturing Phase I, II, and III clinical materials, commercial products, and more.

Our expertise and long history of industry compliance and experience has allowed us to grow and remain a reliable provider of pharmaceutical contract manufacturing services. We recognize the importance of GMP protocols within our aseptic facility and are proud to operate an internationally recognized GMP aseptic processing facility.

GMP Overview

Good Manufacturing Practice, or GMP, is a system used worldwide to ensure products are produced and controlled in accordance with industry quality standards. This is especially important in the pharmaceutical industry.

The sensitive nature of medicines, medical-grade equipment, and medical products can present risks if these items are not produced and handled in a safe and controlled manner. When it comes to pharmaceutical products, anything less than high-quality GMP production could pose health hazards – especially if a lack of quality control leads to an unsafe product. Lax oversight can also result in financial repercussions.

Additionally, GMP is important to help increase business and export opportunities. GMP is internationally recognized as the standard for quality production, which is why many countries will only accept the import and sale of pharmaceutical products that have been manufactured under a GMP system.

Key Features of Our GMP Aseptic Processing Facility

At Oakwood Labs, we take a strategic approach to maintaining an FDA-approved manufacturing aseptic facility. Using an ISO classification system for controlled areas, Oakwood Labs operates and maintains a full suite of core and support manufacturing operations. Some of the key features include:

• In-house QC Microbiology and QC Chemistry
• Raw material dispensing and weighing
• Non-aseptic formulation
• Equipment preparation and staging
• Compact and portable equipment train
• Aseptic formulation
• Aseptic filling
• Aseptic lyophilization
• Vial capping
• Inspecting, labeling, and packaging
• Shipping, receiving, and warehouse space

Services Offered at the Oakwood Labs Aseptic Facility

With our GMP aseptic facility and our expertise in pharmaceutical manufacturing, we are able to provide a variety of services at Oakwood Labs. Some of the services we offer include:

• Formulation and analytical development activities
• Accelerated and long-term stability studies
• Scale-up, validation, and engineering batches
• Clinical and commercial scale batch production
• Complete method transfers and validation
• Batch record and protocol development

Analytical method development and validation can be a complex, costly, and a labor-intensive process. However, at Oakwood Labs, we supply a full range of analytical capabilities in-house in our R&D labs and in our aseptic GMP manufacturing facility, which is FDA approved and meets GMP standards.

By offering these services in-house, our analytical and formulation teams can work closely together and provide quick turnaround on results, assisting in formulation development. Plus, both our R&D facility and GMP aseptic facility have fully functioning labs to support release testing of final products.

Additionally, communication and project management are important parts of our process. Prioritizing these aspects ensures that we are able to achieve the milestones we strive for in a timely and cost-effective manner. Furthermore, our team of highly skilled scientists have years of experience working with diverse products, methods, and technologies.

Learn More About Our GMP Aseptic Facility

Located just outside of Cleveland, Ohio, Oakwood Labs is a specialty pharmaceutical research and development company focused on producing and manufacturing sustained-release injectable pharmaceuticals.

We have partnered with and provided services for many businesses across varied industries. For two decades, our advanced technology, manufacturing capabilities, and internationally recognized GMP aseptic facility have enabled us to grow and supply the highest-quality pharmaceutical services and products.

Contact Us Today

Contact the team at Oakwood Labs today to learn more about the services we offer and how we maintain a GMP aseptic processing facility. We are looking forward to working with you.

Oakwood Labs was founded over 20 years ago as a specialty pharmaceutical company, and we operate as a one-stop source for all aspects of long-acting injectable development. Our focus is placed on developing and manufacturing sustained-release injectables that function to benefit the intended population.

When looking at pharmaceutical development, it is important to take a systematic approach for all of the necessary steps. While we are equipped to assist in any stage of the process, it is important to work patiently in sequential order. For a new project, a pharmaceutical feasibility study is the first step in the process.

Defining a Pharmaceutical Feasibility Study

When you first set out to release a new drug product into the market, it is important to have goals and objectives in mind, and pharmaceutical feasibility studies help assess the practicality of a proposed idea. Put simply, this process is the study of total actions and outcomes.

Pharmaceutical feasibility studies determine processing factors that will lead to an optimized outcome for your pharmaceutical project, which gives confidence that the goals of the process can be achieved. It also can uncover aspects of a project that are capable of fully changing the scope, analyzing these aspects to avoid wasting resources in the future.

The Importance of Conducting Pharmaceutical Feasibility Studies

Feasibility studies are an essential step in the development process because they help determine the suitability of a particular project. The overall purpose looks to determine whether your process is designed properly and precedes the scale-up and development of the sustained-release formulations.

A pharmaceutical feasibility study can also be used to better understand risks that you might encounter and challenge critical manufacturing components. With this progression, you will better understand the expectations against the reality of your project, further being exposed to the difference in planned scale, materials, or even equipment.

Achieving Optimal Timing

The timing of this process must be chosen strategically. If all the feasibility steps are not completed, it is possible that you will end up wasting time and resources in the future. The timeline varies based on each individual project, but choosing the right team to work with can mitigate the lifecycle of the project.

Process Breakdown

The overall goal of a pharmaceutical feasibility study is to determine whether a target product profile is achievable. We study this through a multistep process:

• Pre-formulation activities – This involves developing a strategy for batch production. It is possible to select initial polymer and solvent candidates and understand analytical methods that will provide support to the testing process.
• Characterizing feasibility formulations – Our team focuses on producing batches at a small scale when manufacturing. The data from the first iteration of batches is used to determine the next iteration of batches. Characterization results include drug load, particle size, residual solvents, in vitro release profiles, polymer molecular weight and more.
• Finalizing feasibility report – In this step, we compose a report and prepare for the process of outsourced animal testing. We take the lead candidate formulations and prepare materials that can assist in the animal pharmacokinetic (PK) testing process.

Benefits of Working with Oakwood Labs for a Pharmaceutical Feasibility Study

While pharmaceutical feasibility studies can be seen as an in-depth process, we work to make it as simple as possible. With over 20 years of drug encapsulation experience, Oakwood Labs is considered a leader in the pharmaceutical industry. Our research and development labs are filled with state-of-the-art technology, all of which is available to solve pharmaceutical challenges.

Oakwood Labs is the destination for your project, regardless of your current stage. For rapid formulation development, we typically initiate projects with small batches. Every project is carried out with an experienced formulation and analytical team.

If you are looking for additional support during the development of your project, we have other services to help, including:

• Analytical development
• Scale-up capabilities
• GMP clinical trial material
• GMP contract manufacturing

Request More Information from Oakwood Labs

From pharmaceutical feasibility studies to Phase 3 clinical batches, Oakwood Labs is ready to assist your project.

Request more information today to see how we can help with your next pharmaceutical feasibility study!

At Oakwood Labs, we are known for our experience in pharmaceutical research and development. As a premier resource for all phases of development including Phase 1 clinical trials, we continue to lead the industry, delivering products that provide enhanced therapeutic benefits.

A Phase 1 clinical trial is extremely important as it introduces a new drug to human subjects. Considering this study is critical in early phases of drug development, appropriate guidance and guidelines must be in place. To facilitate these Phase 1 clinical trials, Oakwood Labs maintains an aseptic, FDA-approved GMP manufacturing facility.

By having a GMP facility, it allows our team to follow stringent manufacturing practices, ensuring that pharmaceutical products are controlled and produced to the highest quality standards.

The Goal of Phase 1 Clinical Trials

Phase 1 clinical trials place extreme importance on pharma and biotech companies considering that this is how the safety and efficacy of a new drug is tested. Trials are used to assess and outline the best dosing that should be used in later phases, with the Phase 1 clinical trial being a defining moment, as it shows the chances of future commercialization of the drug.

When it comes to Phase 1 clinical trials, some goals include:

• Demonstrating that patients tolerate the drug well under investigation
• Ensuring that any adverse effects seen from these studies will be used to characterize the profile of a new medicinal product
• Determining the correct dosage and testing different schemes of the compound
• Observing preliminary signs of drug efficacy in regards to the condition or disease being treated

Critical Considerations in a Phase 1 Clinical Trial

With the goal of ensuring high-quality research, certain aspects need to be taken into account when designing trials. Some of the key considerations that our team reflects on in Phase 1 clinical trials include:

• Inclusion/exclusion criteria – These entail the characteristics of the subjects being treated in a Phase 1 clinical trial.
• Treatment scheme – This pertains to how the study’s drugs are being administered, suggesting the experimental drug administration dose and sequence with the best chances of success.
• MTD – An approach is required to determine the maximum tolerated dose (MTD) of the experimental treatment. This necessitates defining dose-limiting toxicities (DLTs), and is a central part of a Phase 1 clinical trial.

Oakwood Labs Offers More Than Phase 1 Clinical Trials

Oakwood Labs has over 20 years of experience, providing services for a variety of businesses across different industries. Our manufacturing abilities and advanced technology has allowed us to supply high-quality services and products.

As an industry leader in pharmaceutical development and manufacturing, we are proud to offer numerous services, including:

Contact Oakwood Labs to Learn More About Phase 1 Clinical Trials

Oakwood Labs is committed to developing reliable pharmaceutical products for our pharmaceutical partners, and we provide the expertise and dedicated staff to help you along the way.

Contact our team to learn more about Phase 1 clinical trials and the other services we can provide. We look forward to hearing from you.

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.