Designed to work as a long, persistent, and rigorous process, drug development is crucial to progressing the field of medicine. Drug researchers and developers are tasked with expanding on previous information and findings in order to combat the rise of new, as well as prevalent, diseases.

Because of this, our team at Oakwood Labs wants to highlight the five drug development stages to further encapsulate the rigor of the process of providing sustained-released injectable pharmaceuticals for the community.

Drug Development Stages Broken Down

As addressed by the FDA, the stages of drug development follow a similar trend for each case. Because of this, we have outlined each drug development stage below, as we feel it is important for our clientele to have an inside look at the processes that we adhere to.

Discovery and Development

Known as the first stage of drug development, the discovery and development stage starts with an initial idea that is fabricated through consistent research and trends. During this stage, scientists discover new insights into the disease process, which allows them to develop a design for a product to either stop or reverse the effects of the disease under consideration. From there, several tests of the molecular compounds are tested to find the possible beneficial effects, or even test existing treatments that might possibly have unanticipated effects.

Once researchers find results of a promising compound through the discovery process, they conduct further experiments to gather information on the following hypotheses:

• How the promising compounds absorb, distribute, metabolize, and dispose of waste
• The mechanisms of action, and how they can be beneficial to further drug development
• The best dosage of the future drug
• The best way to give or take the drug, such as by mouth or as an injectable
• The side effects of the drugs, also known as toxicity
• How it affects individuals of different races, genders, and ethnicities differently
• How it correlates and interacts with other drugs and treatments
• Its overall effectiveness compared to similar treatments

After conducting the series of tests to gauge additional information, researchers are then ready to conduct the preclinical research stage of drug development.

Preclinical Research

As a precautionary measure, researchers must further test their drug for toxicity before distributing the finalized product for public use. Presented in the form of either in vitro or in vivo research, this stage of drug development must be conducted in favor of good laboratory practices (GLP), which can be found in 21 CFR Part 58.1: Good Laboratory Practice for Nonclinical Laboratory Studies. These regulations essentially set the minimum basic requirements for features, such as study conduct, personnel, facilities, equipment, written protocols, and operating procedures, among others.

Though preclinical studies are not usually large, they must provide very stringent and detailed information regarding dosing and overall toxicity levels. Once completed, researchers will assess their findings and decide whether the drug should proceed to the clinical research stage of drug development.

Clinical Research

During this drug development stage, the drug that was initially tested in the preclinical trial will now be tested on people with the hopes of finding how it will interact with the human body. But before the clinical trial can even start, developers will need to design the clinical study for the trial.

When designing a clinical trial, developers follow a specific study plan or protocol that is initially developed by the researcher or manufacturer. Then, the researchers will review the information from the previous two stages to develop research questions, objectives, and decide the following:

• A selection criterion of who qualifies to participate
• The number of people allotted for the study
• The duration of the study
• If there should be the presence of a control group to limit research bias
• How and at what dosage the drugs will be administered
• What assessments will be conducted and what data will be collected
• How the collected data will be reviewed and analyzed for future drug development stages

Unlike the preclinical trials, the clinical trials range from early, small-scale studies to late-stage, large-scale studies.

FDA Review

Considered the final drug development stage, the FDA review team will thoroughly examine the evidence from the drug’s early tests, preclinical and clinical research, and decide to either approve or not to approve the product.

During this stage, a New Drug Application (NDA) must be provided to outline the entirety of the drug development stages that lead to the anticipated approval. The NDA must include the following when presented:

• Proposed labeling
• Safety updates
• Drug abuse information
• Patent information
• Any data of studies that were not conducted within the United States
• Institutional review board compliance information
• Clear and concise directions for use

Finally, the drug is sent for approval to the FDA, where the committee decides whether the drug is safe and effective for public use. The process of approval can take anywhere from 6 to 10 months, as it goes through several inspectors, project managers, and pharmacologists.

From there, the drug is passed to the labeling and marketing stage, where the remaining issues will need to be resolved, and labeling will be provided accurately and objectively for public discretion.

FDA Post-Market Safety Monitoring

Though there are rigorous and persistent steps during each stage of drug development up to its approval and distribution, limitations are still evident and existent. Because of this, the FDA closely monitors drugs for months and even years so they can review the reports on the prescription and decide whether or not to add cautions to the dosage or usage information.

If there were significant changes that needed to be made to a product after the drug development stages were complete, developers would have to file a supplemental application in order to make those changes.

Why Choose Us for Your Pharmaceutical Needs

At Oakwood Labs, we are honored to provide sustained-released injectables to our extensive clientele. On top of that, some of the benefits of working with our pharmaceutical company through each stage of drug development include the following:

• Pre-formulation development
• Feasibility studies
• Scaling formulation
• Toxicology batch manufacturing
• ICH compliant stability tests
• Small-scale to large-scale clinical trial manufacturing
• Commercial and aseptic GMP manufacturing

Contact Oakwood Labs to Learn More About the Stages of Drug Development

If you have any specific questions regarding the drug development stages that Oakwood Labs conducts for sustained-release pharmaceuticals, please contact our team today. We look forward to assisting you in any way we can.

In order for injectables to be able to successfully provide sustained releases, they necessitate drug-encapsulating devices. For over 50 years, encapsulation has been one of the many techniques used in the pharmaceutical industry. In this process, medication is released from a microsphere by the drug detaching from the polymer or through the degradation of the polymer matrix.

Keep reading to learn more about the role of polymer microspheres in the process of drug delivery and how our technology can be an asset to your long-acting injectable project.

The Use of Polymer Microspheres in the Pharmaceutical Industry

Polymer microspheres are often used in drug delivery because they have a high surface area and low particle size, which increases their absorption rate and bioavailability. Since these microspheres are small in size, they are also efficient when moving throughout the body. They are additionally capable of sustained release, making them ideal for use in long-acting injectables for both passive and active targeting.

Capabilities of Microspheres

Microspheres can be organic or inorganic and are designed to encapsulate bioactive molecules and release them in a controlled way. They are used for desired release profiles and can be used to target specific delivery sites throughout the body, including organs.

Additionally, they are considered rigid which means that they can be packed together, found alone, or even combined with other biomaterials to create porous 3D-structured scaffolds. In these scaffolds, they can either serve as a component of a larger scaffold or be the building blocks of one.

Factoring in the Polymer

Polymers can take the role of bioactive or biodegradable depending on the agents they are combined with. When incorporated with therapeutics, polymers become bioactive and provide their own therapeutic benefit. However, they can also be biodegradable which improves release kinetics and helps prevent carrier accumulation.

The benefits of using polymers for encapsulation include the following:

• Ability to encapsulate a variety of drugs
• They have high biocompatibility
• They are bioavailable

Incorporating Chroniject^TM Technology into Your Project

Since polymer microspheres are suited for sustained-release technology, they are the perfect candidate for long-acting injectables. Our technology for microspheres is a patented, polymer-based injectable for drug delivery called Chroniject^TM. This technology is compatible with small molecules, peptides, and proteins. It is also capable of enabling sustained release over durations of two weeks to one year.

Our Chroniject^TM process for microsphere manufacturing initially uses small batch sizes to enable the production of numerous trial batches. This allows us to obtain a formation with the desired release profile and other indicated product characteristics. Additionally, this process can easily be scaled up to commercial production levels with lot-to-lot reproducibility. Since we can produce clinical trial material at the forecast commercial scale, scaling up is feasible at the commercial scale and is conducted in our GMP facility.

Advantages of Using Chroniject^TM

There are diverse advantages of using polymer microspheres and our Chroniject^TM technology for drug delivery, which include the following:

• Rapid development of formulations using small-scale batches
• Easily scaled formations
• Process parameters that are monitored and controlled
• Proven lot-to-lot reproducibility
• Molecule compatibility (small molecules, peptides, proteins)
• Flexible release durations, ranging from one week to one year
• Excellent stability
• Instant reconstitution with WFI – no special diluent required
• Applications in various therapeutic indications (CNS, neurology, ophthalmology)

About Oakwood Labs

Oakwood Labs is a specialty pharmaceutical company located near Cleveland, Ohio. We are focused on developing and manufacturing sustained-release injectable pharmaceuticals, incorporating our microsphere-based technology. We operate in a fully compliant, aseptic facility that is specifically used for manufacturing pharmaceutical products like injectables.

Our goal is to provide enhanced therapeutic benefits to patients while achieving excellent returns for our pharmaceutical partners. With over 20 years of experience, we have proven ourselves as an effective partner of global pharmaceutical firms. From proof of concept and feasibility studies to clinical trials and FDA-approved supplies, the team at Oakwood Labs is ready to help incorporate polymer microspheres into the development of long-acting injectables.

Contact Our Team with Any Questions

If you are interested in learning more about our capabilities in incorporating polymer microspheres into long-acting injectables, please reach out to our team today.

Pharmaceutical peptides play an incredibly important role in the medical field. Years of research has shown that pharmaceutical peptides can have beneficial impacts on your physical health including your body’s ability to heal and maintain strong bones. Peptides are also proven to help build strength and muscle mass, making them among some of the most important building blocks of the human anatomy.

What Are Peptides?

Peptides are strings of amino acids, also known as the “building blocks” of proteins. The human body naturally produces more than 7,000 known peptide types. Along with the peptides that are naturally produced by the human body, they can also be produced in medical laboratories. Pharmaceutical peptides are those that are created using recombinant DNA technology which involves manipulating and isolating DNA segments.

Peptides in pharmaceuticals are also often referred to as therapeutic peptides. They are most commonly used for the treatment of diseases. Some examples of lab-produced peptides are human insulin and growth hormone, both of which can be life-saving for people living with certain conditions.

Getting More Specific: What Are the Benefits of Peptides in Pharmaceuticals?

The development of peptides in pharmaceuticals has made a lot of progress in the last decade thanks to new production, modification, and DNA technologies. Some of the most notable benefits of developing and utilizing pharmaceutical peptides include:

• Low production costs and sale prices
• Oral administration allows for easy delivery to patients
• Good membrane penetration ability

There aren’t many cons when it comes to utilizing pharmaceutical peptides in the medial field, but one that should be noted is they tend to be short lived in the body as a result of rapid degradation and clearance.

Our Capabilities in Pharmaceutical Peptide Production

Oakwood Labs has decades of experience in researching and manufacturing a wide range of pharmaceuticals, including pharmaceutical peptides. Our international reputation for pharmaceutical development is all thanks to our highly skilled, innovative, and knowledgeable staff.

When it comes to utilizing peptides in pharmaceuticals, our team is highly equipped to perform research and lead in the development of individually formulated products for your specific needs.

Oakwood Labs Is an Industry Leader

In addition to manufacturing pharmaceutical peptides, which, as we’ve highlighted, are crucial in the management of chronic diseases, Oakwood Labs provides many other products and services that cater to the medical field. Some of those services include:

• Microsphere formulation development
• Scale-up and technology transfer
• CDMO and CMO services

When you work with Oakwood Labs, you can expect high-quality results every time. We maintain rigorous quality assurance and validation practices to provide the absolute best solutions for our customers. The partnerships we’ve long maintained are attributed to our skilled team and history of compliance.

Reach Out to Us for Pharmaceutical Peptides and More

Oakwood Labs is your source for R&D formulation development through GMP commercial manufacturing. If you’re interested in learning more about our capabilities when it comes to peptides in pharmaceuticals, contact our team today.