Category Archives: Services
When developing and manufacturing a new drug, the list of requirements can get extensive. With the needs for drug discovery, development research, review, and production, there are a lot of moving parts to ensure that a product is safe for patients once it hits the market.
Due to this, assistance for the different phases of pharmaceutical drug development is often sought out, and these support companies come in the form of CDMOs, CROs, and CMOs, organizations that serve the pharmaceutical and biotechnology industries. Learn more about the differences between these organizations in our post so you can determine which will be the most beneficial during your pharmaceutical development process.
CRO vs. CMO vs. CDMO
Let’s explore the distinctions between the three types of organizations that can aid you in your pharmaceutical processes.
Contract Research Organization
A Contract Research Organization, or a CRO, is a destination for research, including clinical trial management, preclinical research, data management, regulatory affairs, and post-marketing surveillance. These organizations focus mostly on research and development services, including clinical trials and regulatory compliance. This means they are involved mostly in the early stages of drug development and play a major role in the overall research and regulatory aspects of drug development.
CROs largely support pharmaceutical companies in research and regulations. Outsourcing to a CRO allows the pharmaceutical company to focus on building other areas of the business and prioritizing other tasks.
Contract Manufacturing Organization
A Contract Manufacturing Organization, or a CMO, specializes in the production of pharmaceuticals and all things related to manufacturing. CMOs are adept at handling large-scale production once the drug has been developed. Their services are beneficial because they utilize cutting-edge technology and have skilled employees who bring expertise to the development process.
Working with a CMO also ensures that the final product is compliant with both quality and regulatory standards, which allows the pharmaceutical company to focus on other things like drug discovery and marketing.
Contract Development Manufacturing Organization
A Contract Development and Manufacturing Organization, or a CDMO, offers a full range of services, from drug development through manufacturing. With operations in place for process development, scale-up, clinical trials, material production, and manufacturing, a CDMO is your end-to-end partner.
Because they are involved throughout the ensure lifecycle of drug development and manufacturing, CDMO facilities help pharmaceutical companies to reduce costs, accelerate time to market, and ensure regulatory standards are adhered to. Consult a CDMO to bridge the gap between development and manufacturing and achieve the most comprehensive solution.
Which Partner Is Best for You?
When deciding which organization to work with, be sure to analyze your company’s needs and challenges. If you are seeking a partner for clinical research support, a CRO is your answer. When you need manufacturing help, a CMO is going to be an ideal match. And if you want to outsource the entire process and ensure everything goes smoothly, a full-service CDMO is going to provide comprehensive and integrated development, support, and manufacturing. When you are looking for a reliable CMO or CDMO partner, Oakwood Labs is here to help.
At Oakwood Labs, we offer CDMO and CMO services for your convenience, and our team has over 25 years of experience with developing and manufacturing injectables for the pharmaceutical industry. We specialize in sustained-release and targeted-release injectables for long-term therapeutic relief. Along with this, our facility follows GMP aseptic manufacturing processes to provide FDA-approved pharmaceuticals to our clients.
Learn More About Our Abilities as Your Pharmaceutical Partner
Please contact us today to learn more about everything we can provide as your CMO or CDMO partner. We look forward to assisting you.
Oakwood Labs is a global leader in sustained-release drug delivery. Our facility provides feasibility studies, analytical development, scale-up capabilities, GMP clinical trial material, GMP contract manufacturing, and sterile fill-finish.
Sterile fill-finish is the final leg of the pharmaceutical manufacturing process, where a substance is filled into vials, ampoules, or other containers deemed appropriate. After the substance is put into containers, it is ready to be sent out for distribution. Learn more about our capabilities for this part of the process below.
The Process for Fill-Finish Pharmaceuticals
There are a variety of reasons that sterile fill-finish is essential in the manufacturing of long-acting injectables. Patient safety is at the top of the list, however, as the approach ensures that the product is free from microbial contamination.
What the Process Entails
When you begin the sterile fill-finish step, you are almost at the end of the drug manufacturing process. However, this is a critical point of the overall manufacturing process because it needs to be done correctly to ensure that your drug is safe for patients. At this point, you’ll want to request help from a fill-finish CDMO who can oversee the process properly.
Some of the steps that will be completed will include:
- Filling – In the filling process, the drug is placed into the final product containers under controlled and sterile conditions. Finish and fill services must be completed in a sterile environment to prevent contamination. For this reason, these services are performed in a cleanroom that has controlled air quality, temperature, and humidity. Additionally, it is important to ensure that sterile filling techniques are also applied to equipment and packaging.
- Container closure – It is important to select the appropriate container closer that is going to maintain the sterility and stability of the drug. Whether this is a vial, syringe, ampoule, or something else, the team you work with will help find the right solution for your application.
- Quality control – In the process of fill-finish for pharmaceuticals, rigorous quality control is practiced to ensure that the product meets regulations. Not only is the product tested throughout the process, but it also undergoes environmental monitoring and final product review to ensure that it is sterile and potent, and that it meets all other criteria that is required.
- Labeling and packaging – Once the product is filled, the finished item is labeled and packaged according to regulations and any requirements provided by outside sources.
- Regulation compliance check – It is important for aseptic, CDMO facilities to adhere to regulatory guidelines like Good Manufacturing Practice (GMP). This helps to ensure safety, efficacy, and quality, completing the final steps of the finish and fill process.
When you choose to work with a fill-finish CDMO, you can also receive different batch sizes to meet your project’s needs. From small-scale clinical trials to large-scale commercial production, our processes can be adapted to your specifications.
Let Oakwood Labs Be Your Fill-Finish CDMO
Oakwood Labs operates a fully compliant aseptic GMP facility. Our FDA-approved facility is headquartered near Cleveland, Ohio and centers on the development and manufacturing of sustained-release injectables for the pharmaceutical industry. We focus on creating pharmaceutical products that provide therapeutic benefits to our patients and excellent returns for our partners.
Whether you need assistance with fill-finish pharmaceutical services or something else, we are here to help. Other services we provide include:
- 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
Consult Our Finish and Fill Services Today!
If you are in need of pharmaceutical manufacturing, partner with Oakwood Labs to receive reliable and efficient services.
Contact us today to learn how you can achieve a sterile fill-finish with our CDMO.
Oakwood Labs has remained a reliable provider of pharmaceutical contract manufacturing services for more than twenty-five years. As a specialty pharmaceutical company, we are focused on two main areas. The first is our CDMO business which is concerned with the development and manufacture of sustained-release injectable pharmaceuticals through the use of our microsphere-based drug delivery technology. The second is our CMO business which focuses on manufacturing sterile injectable products for clinical, registration, and commercial needs.
Our team supports the manufacturing of sterile injectables to provide enhanced therapeutic benefits to patients in addition to excellent returns to our pharmaceutical partners. Sterile injectables continue to grow within the pharmaceutical industry 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
A full service CMO is valuable within the pharmaceutical industry due to its ability to provide aseptic pharmaceutical manufacturing and fill-finish capabilities. Sterile injectable products are an essential part of the global healthcare system. They are used to treat a wide range of conditions, from life-threatening diseases such as cancer or HIV/AIDS to chronic conditions such as diabetes and multiple sclerosis, and many others.
Also, aseptic manufacturing is essential because it minimizes the risk of introducing bacteria and contaminants that can enter the body when administering the medication.
In order to enhance our partnering and sterile injectable development capabilities, Oakwood Labs maintains an aseptic, FDA-approved 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 Oakwood Labs is an effective CMO 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!
Our GMP Aseptic Manufacturing Capabilities
Sterile injections are made possible with procedural measures that prevent contamination, like Good Manufacturing Practices and an aseptic facility. An FDA-approved cGMP aseptic facility for sterile injectables has the ability to support clinical, registration, and commercial batches. We also host short- and long-term stability studies, which help you to achieve the perfect formulation.
Our in-house experience and expertise include method development, qualification, and validation support, as well as robust quality systems. Our team also has aseptic fill and finish capabilities, which means that we can create aqueous, solvent-based suspensions, as well as liquid and lyophilized presentations. The fill volume range is between 1 mL and 30 mL and the vial size range is between 2 cc and 30 cc.
These capabilities allow us to provide value to each partner we work with. If you are looking for a team that will deliver fast turnaround times, expertise in complex processes, assistance in technology transfer, and a high level of FDA quality standards, Oakwood Labs is your destination.
What are the current Good Manufacturing Process standards set by the FDA?
cGMP standards state that a pharmaceutical manufacturer must:
- Have a separate, classified, and clean area for production
- Filter and properly circulate air
- Maintain and sterilize all containers and closures
- Train and monitor all personnel involved with the process
- Wear sterile clothes
- Set time limits for different steps of the process
- Simulate and record the manufacturing process
Answering Your Frequently Asked Questions About Sterile Injectables
What technology is used during manufacturing to create sterile injectables?
Sterile processing equipment is necessary for pharmaceutical production and is essential for satisfying regulatory requirements. Therefore, it is common to see autoclaves, electro-steam generators, and washer-disinfectors in the pharmaceutical manufacturing process.
What are the common routes of administration for sterile injections?
There are four common methods of administration:
- Intravenous
- Intramuscular
- Subcutaneous
- Intradermal
Since injectables bypass the natural barriers of the body, it is essential for them to be sterile to reduce the risk of injections or complications in patients.
What is involved when testing sterile injectables for sterility?
According to the WHO, a pharmaceutical container is defined as sterile when the probability that it is contaminated with replicating microorganisms is less than one out of one million.
Sterility testing often involves the following:
- Biological indicators – Using microorganisms to test for the effectiveness of the sterilization
- Sterility tests – Culturing samples to check for microbial growth
- Endotoxin testing – Ensuring the product is free from pyrogens that cause fever
Since not every container can be opened, random samples are taken and tested to represent an entire batch.
How do sterile injectable drugs get packaged?
Depending on the needs of the patients and facility, sterile injectables can be put into:
- Ampoules – Sealed glass containers that are used once
- Vials – Glass or plastic containers that can be used once or for multiple doses
- Prefilled syringes – Packaged in ready-to-use doses that reduce preparation time and contamination risk
- Cartridges – Units commonly used for insulin
Contact Oakwood Labs to Learn More About 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!
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.
Oakwood Labs is a leading company in the development and manufacture of sustained release pharmaceutical products, specifically microparticles for injection. We specialize in developing microparticle drug delivery formulations with in vivo release durations ranging from one week to one year. To learn more about our process for formulation, keep reading.
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.