Chapter 1: What is a CDMO?
What is a CDMO?
A contract development and manufacturing company (CDMO) is a company within the pharmaceutical industry that provides drug development and manufacturing services. Pharmaceutical companies partner with CDMOs as a way to outsource drug development and drug manufacturing.
Full-service CDMOs can take on every aspect of drug development and manufacturing, and they also work with clients looking to outsource certain components of their process. It all depends on what each client needs.
Some of the services offered by CDMOs include:
When partnering with a full-service CDMO, a pharmaceutical company can begin with little more than a concept and be guided all the way from pre-formulation and formulation development, through clinical trials and commercial production.
What’s the Difference between CDMO and CMO?
The difference between a contract development and manufacturing company (CDMO) and a contract manufacturing company (CMO) is development. CMOs are companies that take a pre-formulated drug and manufacture it, while CDMOs are companies that do both the development and manufacturing of a drug.
Many pharmaceutical companies are drawn to the consistency and timeliness that’s provided by working with a CDMO versus a CMO. At the end of the day, a CDMO partnership comes with fewer opportunities for finger pointing.
When it comes to the complexities of drug development and manufacturing, pharmaceutical companies are relying on CDMOs more and more.
Whether it’s navigating the highly regulated drug development framework required by the FDA or scaling production to meet deadlines and demand, having a CDMO partner can be a great resource with plenty of benefits for pharmaceutical companies to focus their efforts and resources on initiatives that move their company forward.
Chapter 2: Costs & Benefits
Advantages & Costs of Contract Manufacturing
To develop a new drug or drug variation is a multi-year, multi-million dollar undertaking. Partnering with a CDMO for development and manufacturing of a new drug offers numerous benefits to pharmaceutical companies.
Advantages of Contract Manufacturing
With every client partnership, we dedicate our expertise, as well as our equipment and facilities, to expedite the process of bringing a drug to market.
The depth and breadth of experience and specialization you’ll find within a full-service CDMO is remarkable. Due to the core competency of their business, it makes sense for CDMOs to invest in talented researchers, chemists, and development professionals. After all, those that can provide the insight, oversight, and innovation to pharmaceutical companies will be the most successful.
EQUIPMENT AND FACILITIES
Another investment area for leading CDMOs is in equipment. With internal drug development and manufacturing, pharmaceutical companies face a tough decision when they want to increase capabilities, introduce a new drug, or manufacture at a different rate. After all, those decisions all come along with costly capital investments.
Outsourcing with a CDMO, on the other hand, gives companies access to expansive equipment and facilities without taking on the expense of ownership.
CDMO manufacturers are well-known for their ability to help pharmaceutical companies scale. Shifts in production volume or the addition of a new drug variation can be extremely high risk considerations for pharma companies. But when they’re in a CDMO partnership, those decisions are a much lower risk, and they’re accompanied with shorter lead times.
Outsourcing pharmaceutical development and manufacturing enables businesses of all sizes to scale. Large and small pharmaceuticals alike can run leaner and more efficiently knowing their drug development and manufacturing won’t break their budgets.
What to Consider When Choosing a CDMO Partner
When it comes to choosing a CDMO partner, the first thing to look for is if they have the technical expertise and experience to deliver on what you’re looking to accomplish. Do they have relevant experience in the drug delivery systems you’re targeting? Does their staff own the technical acumen to achieve what you’re looking to achieve?
Next, look to their equipment and facilities. What is their investment in laboratory space and equipment? How about machines for mixing, coating, and converting? Do they have the facilities to handle the production levels you seek?
Finally, look at how the CDMO handles partnership and relationships. Are they good listeners? Do they make you feel involved in the process? When things become stressful, are they the type of company who will persevere alongside you? These are all questions to consider when choosing a CDMO partner.
Chapter 3: Drug Development
Develop a New Drug
New drug development is a highly regulated, lengthy process. In the U.S., all drugs introduced to the marketplace over the last 30 years had to navigate the FDA drug development process. Due to its complexity, many pharmaceutical companies rely on CDMOs for drug development services.
WHAT IS A DRUG DEVELOPMENT CYCLE?
The U.S. drug development process, as outlined by the FDA includes five steps:
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- FDA Post-Market Safety Monitoring
DISCOVERY AND DEVELOPMENT
While the concept for a new drug might come about over lunch or as part of a boardroom discussion, every drug’s discovery really begins in the lab. Research and development is an essential component of drug development that forms the foundation for all the steps that follow.
Discovery and development can result in the creation of new chemical or organic compounds, the discovery of new insights about a disease that already exists, and even new technologies for delivering a drug that already exists.
Preclinical research works to determine the toxicity of a compound. Researchers accomplish this by testing it both in vitro and in vivo. It is during this time that scientists experiment with dosage and work to determine safety metrics.
Clinical research examines a drug’s interactions with the human body. It is normal during clinical research for drug trials to be performed on both people and animals. The FDA outlines specific criteria for human testing, which impact all phases of clinical research.
FDA DRUG REVIEW
The next step in the drug development process is FDA drug review. When a company’s research and trials have determined their drug is safe and effective in its intended use, they can file for FDA review and approval. If approved, the company obtains the right to market the drug.
FDA POST-MARKET SAFETY MONITORING
Post-market safety monitoring works to ensure drug safety and efficacy throughout its time in the marketplace. The FDA monitors for problems with prescription or over-the-counter drugs, evaluates and approves changes in dosage or usage information, and conducts routine inspections of drug manufacturing facilities.
CDMO Partnership and Drug Development
Throughout every step of drug development, CDMOs are alongside pharma companies helping them navigate the process and mitigate risk.
All drugs approved in the U.S. marketplace over the past 30 years, whether over-the-counter or prescription, went through an extensive, multi-year, multi-million dollar journey before being available to patients. It is a significant undertaking, riddled with risk, oversight, and regulation.
To bring a new drug to the marketplace requires extensive resources, technical acumen, and an unwavering commitment to the goal: approval. By choosing the right partnerships, you can give your drug development program the competitive advantage it needs to reach the marketplace.
Chapter 4: Transdermal Patches
Transdermal Patch Development with a CDMO
Transdermal patch drug delivery is increasingly being seen as an attractive alternative to oral drug delivery, and in some cases, drug delivery via injection too. While transdermal patches continue to grow in popularity, they have yet to fully actualize in the U.S. marketplace.
What Are Transdermal Patches?
Transdermal patches are a well-established method of drug delivery. They are patches that deliver drugs via adherence to the skin. Manufactured with a specific, predetermined dose of medication, transdermal patches allow medication to be absorbed into the bloodstream through the skin.
As a non-invasive and painless method of drug delivery, many patients and practitioners are coming to know and hold preference for transdermal patches. They have the capacity to provide a constant and consistent therapeutic dosage over a predetermined period of time.
How Do Transdermal Patches Work?
As a method of topical drug delivery, transdermal patches adhere to the skin, where the drug they hold enters the bloodstream after being absorbed by the skin. They are known for providing consistent delivery of small amounts of a drug into the bloodstream over an extended period of time. Because of this, the length of wear time and the amount of drug delivered is different from patch to patch.
Transdermal patch drug delivery systems are made up of a few basic components. They include a backing layer, drug reservoir/drug membrane, adhesive, and liner. Depending on the design and complexity of the patch, these components may be arranged differently or combined in interesting ways.
These different methods result in different types of transdermal patch designs. Some of the most common designs are matrix, reservoir, multilaminate, and drug-in-adhesive.
How to Apply a Patch
For transdermal patch application, always follow the directions of your practitioner, referring to the directions that accompany the patch. Here is a basic outline for transdermal patch application.
- Wash your hands and the application area
- Hold the patch securely
- Peel off one side of the patch’s backing
- Apply the exposed half of the patch to the application area
- Press the patch against the skin and smooth it down
- Remove the remaining packaging
- Smooth the entire patch against the skin
- Wash your hands
For more detailed application and removal information, click here.
Types of Transdermal Patch Drug Delivery
Passive vs Active Systems
Passive systems are those that rely on natural diffusion to transfer a drug from the patch to the skin and into the body. They are known for their consistent diffusion rate.
Active systems are those that use a method to aid in the transfer of a drug to the skin and into the body. These methods include chemical enhancers and permeators, physical aids like micro-needles, and low electrical current like iontophoresis.
Transdermal Patch Side Effects
As with any drug delivery system, there is the possibility of side effects that can come from the drug or the patch. It’s a good practice to talk to your doctor about risks and side effects before using a new drug. Ask about:
- Expected side effects
- Possible side effects
- Possible drug interactions
- Drugs or foods to avoid
- Environmental factors, like sun sensitivity
- Instructions for applying, wearing, removing, and disposal
If signs of irritation occur, it’s a good practice to remove the patch and get into contact with the physician or medical professional who prescribed or recommended the treatment.
Developing and Manufacturing Transdermal Patches
Like with any drug and drug delivery system, developing a transdermal patch is a major undertaking. It requires years of dedication and research, millions of dollars, and navigating a lengthy approval process following the FDA’s drug development guidelines.
With varying levels of complexity in formulation and patch design, the learning curve with transdermals can be enough to dissuade many. However, the significant benefits — and opportunities within the marketplace — ensure transdermals maintain their appeal.
The possibilities for transdermal patches are near-endless, but a pharma company’s capabilities will be determined in large part by the CDMO partner they choose.
A full-service CDMO with expertise in transdermal patches, alongside experienced staff and expansive equipment and facilities will provide the best environment for bringing a transdermal patch to the marketplace.
Chapter 5: Topical Drugs
Topical Drug Development with a CDMO
Topical drug delivery systems provide excellent treatment options for a variety of needs, pains, and ailments.
What Are Topical Medications?
Topical medications are medications applied onto the body to treat various ailments. Most commonly, a topical drug delivery system is applied to the skin, where the medicine either treats only the area of application or is absorbed into the bloodstream through the dermis.
Topical vs. Transdermal
You may be wondering, are topical drugs the same as transdermal? Well, sort of. Remember, topical medications are those that are applied onto the body, and transdermal patches are adhesive patches that carry drugs and administer medication once applied to the body. While transdermal patches and topical drugs are not the same thing, it is accurate to say that transdermal patches are a type of topical drug. It’s worth noting, though, that there are many different types of topical medications.
Topical medications come in many forms:
Topical drug delivery can take any of these forms.
Topical Medication Formulation
CDMOs formulate topical medications for direct application to the skin. Developed for the treatment of a wide variety of ailments and treatments, topical medications can also be those which are applied to the eye, into the ear, or on the surface of a tooth.
Topical medications can be formulated with varying levels of potency. Different bases can drive medication into the skin more or less rapidly, depending on absorption speeds.
Qualities capable of impacting the patient experience, from absorption rates to skin sensitivity, remain major factors when formulating topical medications. Along with the drug's active ingredients, there are base ingredients along with other ingredients such as scent enhancers and carriers.
As a rule of thumb, different formulations can result in different clinical outcomes, even when the same ingredients are involved. A CDMO will work with a pharmaceutical company on formulation to ensure the final product is developed to satisfy their preclinical and clinical goals.
Chapter 6: Unit Dose Semi Solids
Unit Dose Drug Development with a CDMO
What is a Unit-Dose System?
Unit-dose drug delivery systems provide patients with individually packaged doses of medication. This single-dose packaging allows for drugs to be pre-metered and quickly accessible. Unit-dose systems are used to treat and aid a variety of conditions including fungal, itch, dermatitis, and beauty.
Like any drug, those developed for single-dose packaging come in varying levels of complexity. They require product formulation, testing, prototyping, pre-clinical trials, clinical trials, and every other step in the drug development process.
Single-dose packaging is growing in popularity for a wide range of topical medications, including lotions, creams, gels, and pastes.
A full-service CDMO with expertise in topical medications will, at minimum, be able to advise you and your company about the benefits and potential drawbacks of investing in unit-dose drug delivery systems. Some will have the necessary expertise, engineering capabilities, and equipment to develop, manufacture, and package unit-dose medications.
Advantages of Unit-Dose Drug Delivery
Advantages of the unit-dose drug distribution has a lot to do with the patient experience as well as compliance.
Single-dose packaging is portable, meaning it’s easy for patients to bring it with them wherever they go. There’s no need to search for a special container or pouch to house the medication, as the manufacturer has already taken care of this.
Single-dose packaging is predictable. With the correct dose amount pre-metered into the packaging, patients don’t have to bother with memorizing the dosage, and practitioners can be rest assured that patients will not over or under apply their medication.
Single-dose packaging is accessible. Patients of different ages and abilities can have more freedom and ease when it comes to taking their medication.
When you choose a CDMO to develop and manufacture a unit-dose system for your drug, choose one with experience and expertise in everything from formulation and handmade prototyping through large-scale registration and commercialization. At the end of the day, you want to end up with a solution that will be successful with practitioners and patients.