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Step-by-Step Success

Tue, 10/16/2012 - 10:57am
Jonnatha Mayberry, Associate Editor

The process of pharmaceutical lyophilization consists of a number of steps, which gradually turn the product from its original form into a lyophilized product. During lyophilization, small steps are essential, and small-scale progress leads to a better result. It is fitting, then, that a company that specializes in lyophilization has created a versatile, state-of-the-art contract manufacturing facility by starting small and expanding gradually. 

Located in the small city of Lodi, in south-central Wisconsin, Anteco Pharma LLC was launched by pharmaceutical industry veterans Howard Teeter and Chris Conlon in 2003. The company specializes in the lyophilization and related processing of pharmaceutical intermediates, medical devices and specialty food and nutritional ingredients.

Growing Gains

In 2004, Teeter and Conlon built the first Anteco building. In 2007, Anteco expanded the facility further, adding more space, but keeping its services the same. By 2010, the original building and the new expansion were already completely full.

The company decided that an expansion was in its best interest for a number of reasons. “One of the reasons we had to [expand] was that not only did we not have space, but when we’d meet new customers, or talk to potential investors, we’d have to say ‘well, we’re full,'" says Howard Teeter, President of Anteco Pharma. “The other problem was that some of our customers were looking to grow, and it wasn’t a matter of saying, ‘OK, we’ll just take part of your business away.’ Keeping any of that business required us to grow with them.”

The extra space would create a separation between pharmaceutical/medical device processing and nutritional product processing. Additionally, the expansion would offer more storage for materials, add aseptic filling capability and provide room for additional growth.

Anteco started planning for its new expansion in mid-2010 by working with Bachmann Construction, a design-build firm. Construction started in October of 2011 and was completed swiftly, ending in July of 2012. Installation of equipment and validation are scheduled to be completed by the end of October of 2012.

Anteco’s expansion took the once 13,000-square-foot facility and added 27,000 square feet, more than tripling the facility’s size. The expanded facility now boasts six Class 10,000 (ISO 7) manufacturing suites (with ISO 5 capability in one of the suites), secure general and equipment storage, state-of-the-art surfaces and six lyophilizers.

A Variety of Capabilities

Anteco offers a solid set of contract manufacturing services, including process development, scale up and documentation; formulation; GMP compliant lyophilization (both bulk and vial); GMP packaging; aseptic filling (pharmaceutical and medical device); and material handling (milling, blending, bulk and consumer packaging).

The facility is well-equipped to store and process large shipments, with some room left over for future endeavors. Receiving and shipping areas are important for Anteco, as “many of the company’s shipments tend to be relatively big,” says Teeter. Storage includes an air-conditioned secure storage area for chemicals and other materials, which is not classified, but is supplied with HEPA filtered air and features the same controls as the manufacturing suites. In addition, there are a number of other specialized storage areas ranging from walk-in freezers at -35°C and -10°C to refrigerated rooms (4°C) and a large general storage area.

Successful lyophilization at the facility relies on strategic receiving areas and quick footwork. “We receive products in a variety of forms,” says Teeter. “Sometimes they’re already frozen, either in blocks or in beads, but sometimes they come in as liquids, and we have to either blend them with something or formulate them in some way, and then put them in a container and freeze them.” Anteco’s strategically placed freezer in the receiving area allows operators to handle materials that need to be frozen without actually entering the cleanroom space.

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When operators are ready to enter the cleanroom space, the timer-controlled double doors offer an extra level of air-quality control. Operators simply step in front of the outermost door, press a button, and wait for the door to rise. Once they step in, the door closes behind them, sealing them between the two cleanroom doors. After about 15 seconds, the second door rises, welcoming operators into the suite.

Cleanroom suites feature plastic, seamless walls, as well as easy-to-clean epoxy floors that also provide traction for operator safety. Gasketed, sealed ceiling tiles “give the facility more flexibility in terms of construction” and they also “wash and sanitize well,” Teeter explains. All of the suites are “HEPA filtered and capable of achieving Class 10,000 (ISO 7).”

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The facility’s six lyophilizers offer a wide range of capacities: “one has a capacity of over 2,000 L, another is about 700 L, two are 450 to 500 L, and one is 200 L. We’ve kind of covered the gamut,” says Teeter. “All of them have the capability of drying product in both vials and bulk.”

Anteco’s main focus is overall flexibility, but it realizes the need to have fixed processing areas in some cases. “I would say in general, nearly everything we have is modular,” says Teeter. He explains that there are some exceptions to Anteco’s modular approach. For example, Anteco supplies wound dressings to one client, and currently, “a lot of packaging is manual.” Because Anteco’s wound-dressing client’s business is growing, Anteco plans to implement more automated systems. “In that case, it will have to be permanently installed,” Teeter says. “We really have to have a combination of fixed, dedicated rooms and modular rooms.”

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 An Eye on the Future

Anteco’s history of growth means the company always keeps future growth in mind. As such, the company also allotted 2,000 square feet of the expansion space for future process suites and 600 square feet for a future laboratory/pilot lab.

Teeter says that Anteco foresees expansion into offering “medium-speed vial/bottle filling lines for pharmaceutical and medical device applications, sterile lyophilization, automated dispensing and pouching equipment, microspheres production for diagnostic applications, GMP laboratory services and expanded product and process development services.”

During our tour, Teeter pointed out a few rooms that are poised for future growth. For example, one of Anteco’s small-volume sterile processing rooms may eventually house a permanently installed vial filling and stoppering machine. “We’ve been looking at several options for that, both new and used, and we’d hope that one is installed by late this year.” Anteco is also considering adding “an isolator filling/lyophilization station.”

Yet, for some of the spare rooms, Anteco likes to leave the future up to chance: “I’d prefer to wait and see what opportunities come. I’d be more than happy for a customer to come in here and say ‘build it out,’” says Teeter.

 

Keeping Facilities Up to Date

One of Anteco’s achievements is its ISO 9001 and ISO 13485 certification.

According to Teeter, Anteco appreciated ISO 9001’s focus on customer satisfaction and its process-based methodology. Its original quality system was designed on an ISO 9001 format, incorporating drug and medical device standards as appropriate. Teeter says that Anteco's official ISO 9001 and ISO 13485 certifications came later, “primarily at the request of our first medical device customer (international) who wanted ISO 13485.”

“The fact of certification has varying degrees of importance to customers,” Teeter explains. But he acknowledges that “The result of the certification process has great impact for all clients since it defines internally our focus on meeting customer expectations in every way possible.”

In addition to certifications, Anteco is always striving to make sure that its facilities and practices are up to date with the latest FDA standards. Company leaders read trade journals, subscription reports, government announcements and other such sources of information to stay abreast of new developments. They also participate in periodic regulatory conferences and courses.

Anteco also works with clients, prospective clients and vendors to assure that everything is up to date with FDA and international regulatory standards. Teeter explains that “customer and certification agency audits” are also important parts of Anteco’s focus on continual improvement.

Thriving through Teamwork

The solidarity between the company’s founders is evident, and that team mentality influences every aspect of the company, including the bare bones of a manufacturing facility — the building itself. “We’re equal partners in this,” explains Teeter. “Chris is an engineer, and I’m a chemist by training. We’ve pretty much been involved in all parts of the industry, but he’s a really great designer — both the original building and this new one are largely his design.

Anteco’s team mentality shines through when it comes to working with equipment vendors, as well. Teeter says that the expertise of Anteco’s equipment vendors has contributed to the facility’s success. “We believe in outsourcing, and equipment vendors are usually the most effective and least costly resource.” The facility purchases refurbished equipment when possible, but when new equipment is used, Teeter says that the vendors have always been great to work with.

Perhaps the most valuable outcome of Anteco’s team mentality is the company’s approach to staff training. Teeter explains that the company’s staff stands out partly because of their “team approach to all client projects, their customer commitment and involvement and their technical and mechanical competence.”

Building a Client Base

In Anteco’s early days, the company’s client base was mainly centered around people with whom Teeter and Conlon were already acquainted. “Marketing has always been an issue as we have grown from two guys with a large bank loan to a company with clients worldwide,” Teeter explains. “Until our recent expansion, business was generated from contacts that Chris and I developed over long careers in the pharmaceutical/medical device/dietary supplement business.” For the last couple years, Anteco has been at “nearly 100 percent capacity, so business development was mainly focused on attracting long-term customers to support construction of the expansion.”

Now that the expansion has been completed, Anteco is ready for a bigger client base: “We are actively working on all aspects of a formal sales/marketing effort — including adding personnel.”

Although Anteco plans to increase its client base, it also wants to stay true to its roots. Teeter explains that, in the past: “Clients have chosen Anteco Pharma, in part, because our small size facilitated quick response, intense customer focus and technical focus.” Now, as Anteco looks toward the future, it aims to retain those qualities.

Working with Clients

Anteco realizes the importance of keeping the client involved in every step of the process, offering many opportunities for the client to get involved with the project. “Projects are typically preceded by customer visits and audits so that they better understand our facility, capabilities and practices,” Teeter explains. “Client involvement is usually defined in both manufacturing agreements and quality agreements,” and clients are also “encouraged to be present when development or process activities occur.” Every proposal and agreement also includes scheduled visits and/or teleconferences, guaranteeing that the client has the opportunity to be involved as much as they would like.

Clients’ proprietary information is closely guarded. “A signed CDA always precedes any substantive discussion,” explains Teeter. Employees are also well trained on the importance of confidentiality. All employees are trained on maintaining client confidentiality, and they also sign a CDA as part of the hiring process.

A Personalized Approach

Teeter sees a great deal of growth on the horizon — not only for Anteco, but also for contract manufacturing as a whole. At the end of the day, however, Anteco wants to grow without outgrowing its individualized approach.

In the beginning, Anteco’s small size allowed the company to “be very intensely connected” to customers: “They saw the facility and they knew the actual people who were working with the project,” Teeter explains. As Anteco grows, it’s not looking to overhaul its policies. “We will always try to remain very scrupulous about customer engagement.” In the beginning, “we didn’t really have any specific marketing — we just tried to meet people and find out what they needed. As we grow, I want to maintain that.”

Anteco was originally just two people, but as it gained employees and expanded, its founders have overseen every change and worked toward the same goal. “We want to make sure the next generation of leaders continue and expand both customer focus and technical excellence,” says Teeter. For Anteco’s founders, the company is not only a job, but a passion: “I came into entrepreneurship kind of late in my career, but it’s great — I should have started much earlier,” Teeter explains. “The whole thing has been an adventure.”

 

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