Why would a company partner with a full-service CDMO? Speed and simplicity are good reasons to start. CDMOs provide a single source for the development and manufacturing of pharmaceuticals, and they offer comprehensive services throughout each phase of bringing a drug to market.
Throughout this article, I expand on how a CDMO can benefit pharmaceutical companies of all shapes and sizes, but if you want to learn how a CDMO can benefit you specifically, let’s talk.
Now, let’s start with the basics.
What is a full-service CDMO?
A full-service contract development and manufacturing organization is a company within the pharmaceutical industry that other companies contract with to receive complete drug development and drug manufacturing services.
It’s becoming more and more popular for large pharmaceutical companies to choose outsourced drug development and manufacturing. With outsourced pharma, businesses are able to lighten their load and dedicate more resources toward initiatives that create greater impacts, like drug discovery.
Full-service CDMOs can take on every aspect of drug development and manufacturing, and they also work with clients 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 preformulation and formulation development, through clinical trials and commercial production.
As a result, CDMOs are increasingly being used to serve as the client's development and manufacturing groups. This, in turn, provides a host of benefits.
Advantages of CDMO Partnership
Increasing drug substance complexity creates challenge after challenge for pharmaceutical companies working to identify process routes that allow swift progress through clinical development phases.
When the goal is bringing a drug to market, speed is of the essence, and inaction comes at great cost. CDMOs are at their best developing innovative approaches and finding solutions that enable complex drugs to quickly reach the market.
One way of increasing delivery velocity is by creating a culture of collaboration and providing an environment that facilitates communication between teams. At Tapemark, we were built to do just that.
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. At Tapemark, our experts make innovation in the arenas of drug development and manufacturing the norm.
For example, within our Analytical Services offering, our talented drug substance process chemists are routinely supported by experienced analytical chemists to ensure rapid development and optimization. With guidance on formulation from integrated drug substance chemists, we capitalize on both clear and unambiguous data to optimize drug form.
In fact, throughout every service offered, you’ll find a unique and supportive team atmosphere, which leads to rapid drug substance and drug product delivery, reducing costs overall. Having this culture grants us the ability to deliver pharmaceutical products more efficiently to our clients, especially when compared with other companies who are locked into existing assets. At the end of the day, our expertise is favorable for both parties.
Here’s a quick look at a handful of experts who make Tapemark’s CDMO services shine.
Research and Development
As our Research & Development Director, Marina Ruleva owns over 15 years of experience in mixing and coating across various industries. Marina’s knowledge, capabilities, and persistence positions her to overcome the most complex formulation challenges.
As our resident expert on Analytical Services, Bryan Kiefat relies on over 20 years of experience to find the right answers to some of the toughest pharmaceutical questions. In this highly regulated industry, Bryan leads a diverse, well-rounded team of chemists.
As our VP of Engineering, Steve Rau draws from over 25 years of pharmaceutical and medical devices experience to provide insight and innovation for our clients. By taking a global approach to problem solving, Steve is an expert at preventing negative outcomes.
As our Senior Director of Quality Assurance, William Pfeiffer utilizes over 20 years of cGMP manufacturing experience in the pharmaceutical and biopharmaceutical industries to ensure quality and regulatory compliance is built into every project.
Equipment and Facilities
Another benefit clients receive when partnering with a full-service CDMO is access to their equipment and facilities. With internal drug development and manufacturing, the decision to increase capabilities, introduce a new drug, or manufacture at a different rate comes along with costly capital investments. Outsourced pharma, on the other hand, give companies access to expansive equipment and facilities without taking on the expense of ownership.
So you may be wondering, what are the equipment and facilities requirements for a full-service CDMO? While there’s no exact answer, we can share with you a bit about ours — and when you partner with us, you can expect an in-person tour of our equipment and facilities.
We continually invest in our production facility and equipment, ensuring both remain state-of-the-art. It is a facility designed to benefit our clients. A facility with unmatched capabilities in the CDMO space.
Tapemark’s Equipment and Facilities
Our facility comprises two buildings. One building houses our analytical lab, mixing and blending suites, and coating operation. The other houses the majority of the converting operation and finished shipment process. In total, we have 13 cleanroom suites.
Our equipment and facilities are designed to handle highly complex products and processes. We offer high-speed packaging including state-of-the-art, track-and-trace serialization to meet agency regulations. We offer a fully integrated solution from start to finish for the benefit of our clients.
Many companies choose to partner with a full-service CDMO because it enables them to scale more easily. Need to ramp up production during the busy season? Looking to add a new drug or variation to your lineup? A CDMO has the facilities, equipment, and expertise to make it happen.
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.
Tapemark Helps Businesses Scale
Tapemark provides capabilities that are fully integrated with pre-existing services. With the integration of analytical and process engineering controlled within a closed loop manufacturing process, we’re able to create a scalable solution quickly and effectively.
When combining state-of-the-art technologies with innovative site capability and analytical discipline, we ensure that the client is always supplied with high quality products. Clients without this proven method of capabilities will be forced into costly development time within a rapidly changing pharma industry.
CDMO Services at Tapemark
CDMOs are increasingly being used as a client’s development and manufacturing department, and for those of you wondering, Tapemark provides a fully-integrated solution. Throughout every stage of bringing a pharmaceutical drug to market, we guide our clients with an expert-level, hands-on approach.
Our end-to-end CDMO services include every stage of contract development for transdermal patches, transmucosal films, and unit dose semi-solids. Our nearly 70 years of industry experience allows us to select projects that fit directly within our expertise, enabling us to deliver innovation and excellence for our clients. With a team of tenured experts, we help clients receive FDA approval at greater speeds and within budget. When you need pharmaceutical development and manufacturing, partner with us.