CDMO Tapemark possesses not only a broad range of capabilities in transdermal patches and oral thin films, but also a Midwestern commitment to personalized service.

All contract development and manufacturing organizations (CDMOs) as well as contract manufacturing organizations (CMOs) have a niche—a special place in the market where their expertise and offerings are entirely unique to their company and surpass that of their competition. For some companies this could be expertise in handling potent drugs, for others this could be their all-inclusive offerings, while yet for others it could be their R&D and preclinical research capabilities.

For CDMO Tapemark, it is their knowledge in transdermal patches and oral transmucosal thin films for the pharmaceutical and medical device markets, along with their Midwestern commitment to personalized service.

“The company has been around 64 years now,” said Andy Rensink, President of Minnesota-based Tapemark. “Because of work we’re already doing in converting transdermal patches, oral thin films, and finished dosage form, we saw a unique opportunity to vertically integrate and be able to go all the way from formulation through to commercial production. So, we set a target that we wanted to become a world-class developer and manufacturer of transdermal patches and oral thin films.”

Over the past several years, the company has not only invested heavily in building a manufacturing facility for transdermal patches and oral thin films, but they have also invested in building an R&D staff to be able to work with the dosage forms.

“We’ve come a long way,” said Rensink. “We have customers who knew us only as being packagers in the past. They’re often times surprised and excited to see we now have API finished dosage form capability. . . . To be able to have the experience in scaling up and manufacturing commercially allows us to be able to provide unmatched parallel personalized service for our customers.”

Mastering the Process

“For a transdermal patch, an oral-dissolvable film, oral transmucosal film, or other [delivery], there’s three basic sub-processes involved,” according to Dr. Cormac Lyons, Vice President, Research & Development, Tapemark, which are:

1. Mixing/blending
2. Coating
3. Converting/packaging

“In the mixing process—for the patch, for example—you basically are blending an adhesive with a drug or other excipients,” said Lyons. “The key challenge there is to get a homogenous (and stable) mixture blend without destroying your drug. It involves knowledge of the materials, of what the properties of the product need to be, and the mixing equipment that’s appropriate for that product. And that’s expertise that we’ve garnered over several years.”

The coating process involves taking a polymer liner, metering your blend onto it, and then the wet-blend on the liner/laminate goes into a convection oven—after which point you would then wrap up your laminate.

“That laminate then goes to the last step of converting and packaging, which in my experience is frequently an overlooked or underestimated process,” said Lyons. “It can be quite involved—converting the patch from a laminate into a single patch and then putting it into the pouch. It takes a lot of expertise… It’s a pretty steep learning curve. Tapemark has engineers and processors who’ve been doing this for decades.”

What Differentiates the Tapemark Team

In addition to transdermal patches and oral thin films, there are three things that separate the Tapemark team from their competitors:

1. The ability to go from pilot-scale all the way through full-scale, commercial manufacturing

“There are a number of formulators who have formulation capabilities,” said Rensink. “There are those who will do coating; there are some who will do just converting. There are very few who have that end-to-end capability.

“In addition, the converting element of that—the die cutting, pouching, and final packaging of dosage forms—is a complex part of the operation. That’s what we’ve been doing for 60 years. We have multiple suites of equipment to do that.”

2. Personalized service

“Instead of a one-package-fits-all, we adapt ourselves to what our customers’ needs are. They have different filing strategies and different needs of speed to market. Some of them have formulation work that’s partially done or IP that belongs to others, and we have a way to reach out and work with all of those customers,” said Rensink.

“We also assign a team to go with each project, and they stay with it all the way through,” explained Steve Larsen, Vice President, Business Development. “We encourage similar backgrounds to have access to each other. For example, our technical is talking to our client’s technical; our quality is talking to our client’s quality, etc.—all the way across so we’re not losing messages going through one point of contact and back out again.”

3. World-class equipment and facilities

“Our investments over the last few years have been specifically tailored to these dosage forms. We’ve built a world-class capability in our facilities and equipment,” said Rensink.

Part of that investment was for handling Schedule drugs, as the company has Schedule II-V capability. In addition, this investment was not strictly for analytical capabilities and lab expansion, but for full-scale commercial capabilities, including a drive-in vault.

“We have brand-new lab facilities fully equipped with the latest state-of-the-art equipment. We have mixing and blending suites with multiple size and viscosity ranges,” said Rensink. “We have pilot-scale coaters and full-scale production coaters where we do the majority of our development work, which gives us an edge up on commercial manufacturing.”

The Tapemark Facility

The company’s campus is located in West Saint Paul, Minnesota and contains two buildings within the facility.

“One of the facilities that we just completed renovation on is where we’ve installed all of the new labs—mixing and coating—as well as some new converter capabilities at that facility. Both facilities are capable of handling Schedule drugs,” said Rensink, adding that they have 14 cleanroom suites that can conduct a variety of activities.

Between the manufacturing space, labs, and various cleanrooms, the two buildings sit at approximately 150,000 square feet.

“We have roughly 140 employees, and we’ve got another 40-50 contract employees,” said Larsen. “As a CDMO, obviously our need for employees ebbs and flows with our customers’ demand. So, the contract employees help us smooth that out.”

“Being a converter for 60 years, we have multiple suites of converting equipment to be able to handle very complex products,” said Rensink. “We have just finished the investment of high-speed packaging that includes state-of-the-art track and trace and serialization, which is an important component for our customers based on the new FDA regulations. Across the board, it starts from lab all the way to the final pack out, track and trace, and uploading data into the cloud.”

What Customers Are Asking For

As a company, Tapemark has a lot of “OUS customers who are looking to get a foothold in the United States,” but also U.S.-based customers, Larsen explained.

Schedule drugs, if they are sold in the U.S., have to be made in the U.S. Therefore, any OUS company has to have a commercial manufacturing site in the U.S.—which is where Tapemark comes in.

According to Larsen, Tapemark customers are typically looking for the following:

1. Speed to market

“We’re fairly heavy into the generic space for both transdermal patches and oral thin films. What we’ve seen there is a drive toward speed to market. Our customers are asking for that,” said Larsen. And, as we know, the generics space is competitive, with the first ones to the market typically doing much better.

“Our customers are driving us for speed to market, and that means a lot of things. Specifically, ease of doing business. We don’t typically have a lot of red tape to get a project moving. In a lot of cases, we don’t even need a contract in place before we start doing work. We’ll agree to a statement of work, understanding the costs associated with that work, and we can begin moving with that. Subsequently, we get those agreements in place, but we don’t hold up a project waiting for those agreements,” said Larsen.

2. Technical expertise, specifically in the transdermal patch and oral thin film space

“The transdermal patches and oral thin films are fairly unique markets,” said Larsen.

Many of Tapemark’s customers come to them with experience in something such as solid oral dose. They often are not, however, intimately acquainted with the transdermal and oral thin films space.

“To have that level of understanding going in, we can tailor what we’re doing to fit the customer’s needs. They may not know the regulatory pathway for transdermal patches or oral thin films, and we can help them with that,” said Larsen.

3. 505(b)(2) opportunities

“The other thing we’re seeing is 505(b)(2) opportunities—more so in the oral thin film space, but also in the transdermal patch space, too,” said Larsen. “And that has different challenges. It is typically a product that hasn’t been made before, and we’re faced with those challenges in the formulation and manufacturing stages.”

With 505(b)(2) projects, the Tapemark team might be approached with a molecule—wherein the client may ask first if they can deliver it and, secondly, what dosage forms it can be put in.

“We have a solid technical team that has a lot of experience in both of those platforms that can overcome any technical challenges that we see along the development process,” said Larsen.

Open Door Policy

“The best thing for us is if a customer comes to Tapemark and visits us,” said Larsen. “They get to meet our people, they get to see our facilities, and they walk away understanding our depth and breadth of knowledge from an expertise standpoint. Our equipment and facilities are top-notch.”

Tapemark also prides itself in being a one-stop shop, or having full-service capabilities.

“Customers don’t have to go to multiple CDMOs to get a project done,” said Larsen. “They don’t have to go to one place to get a drug manufactured, another place to get the cutting and packaging done, and a third place to get the pack-out done. We can do it all internally here.”

This cover story can also be found in the November/December 2016 issue of Pharmaceutical Processing. 

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!