With a 60-year company history, Tapemark
is no stranger to change. Now focused on contract manufacturing of pharmaceutical,
medical device, and consumer products, the FDA-inspected, ISO 9001, and ISO
13485 company continues to grow at its multiple-facility campus in West St. Paul, MN.
In keeping pace with their peers on the CMO landscape, Tapemark has made a number of investments. Steve Larsen, the company’s national sales manager, recently sat down with Pharmaceutical Processing to discuss some of the trends impacting his and other contract manufacturing organizations, and how Tapemark addresses them in order to grow.
Pharmaceutical Processing: What are some of the general trends you see impacting the pharmaceutical marketplace?
Steve Larsen: There are an increasing number of blockbuster drugs coming off patent, and pharma companies are searching to replace those dollars. One of the trends in the industry is to extend the life of those drugs by using a new delivery format, such as a transdermal patch. As both a drug and device contract manufacturer, Tapemark is in a unique position to respond to this need.
We also are seeing a trend for big pharma to use products and technologies developed by smaller R&D companies. As such, contract manufacturers are working with R&D companies early in the project to consider manufacturability and cost-effectiveness. As the R&D company shops their product to big pharma, they find it beneficial to have a contract manufacturer who has produced clinical trial samples and whose production capabilities are scalable to commercial volumes.
Pharmaceutical Processing: What are some of the biggest challenges you face in working with smaller companies seeking to partner with a contract manufacturer?
Steve Larsen: The main challenge is often funding. If they do not already have a marketing partner lined up, it’s important that a smaller company have some venture capital backing so they can proceed without costly delays. We also spend quite a bit of time educating some of our smaller companies on the regulatory processes and various requirements at different stages of development.
Pharmaceutical Processing: Quality is obviously always a key focus, but the headlines generated by recent recalls have really put QC in the spotlight. What are some of the things Tapemark does in assuring their customers of product quality?
Steve Larsen: With the number of different customers we work with, we are audited fairly frequently – 20 to 25 times a year, on average. We welcome every audit opportunity and we continue to learn and improve each time. We’re quite proud of our proven quality systems and that our most recent drug and medical device audits found zero 483’s.
We focus on Quality by Design. Tools and resources such as Design for Six Sigma, our phase gate process, implementation of statistical analysis, our newest class of Black Belts, and an ongoing focus on continuous improvement are just some examples showing Tapemark’s commitment to quality.
Pharmaceutical Processing: What are some of the most recent investments Tapemark has made?
Steve Larsen: There are three I’d like to mention. First, we invested quite heavily in a new product platform for unit-dose semi-solid dispensing, called Snap!®. We own the IP for this proprietary packaging. Our Snapplicator™ version, which includes an applicator, is drawing tremendous activity.
Secondly, our most recent facilities investment was to prepare for, and subsequently receive, DEA approval to handle Schedule III – V drugs as a contract manufacturer. We’ve been working with scheduled drugs since this past fall.
Finally, we have invested in employee education, supported
by a three-year Minnesota Job Skills Partnership Program grant. The grant, and
matching Tapemark funding, provided nearly a million dollars of training for
Pharmaceutical Processing: What does the future hold for Tapemark?
Steve Larsen: Unlike other contract manufacturers that only work with drugs or only devices, Tapemark’s future includes a strong focus on drug/device combo products. For example, we’re working with passive and active transdermal patches, including technologies such as iontophoresis, microneedles, thermal poration and dermabrasion. With the ability to handle scheduled drugs, we expect to see continued growth in this space.