Beyond Service

Today’s contract manufacturers/packagers aren’t merely following customers’ orders—in many cases their expertise sets the tone and pace of the partnership.

In many instances, contract packagers (aka outsourcing service providers) have invested in specific technologies or capabilities to be able to provide their pharmaceutical and medical device customers with a competitive edge.

For example, AndersonBrecon (www.andersonbrecon.com), a global supplier of pharmaceutical commercial packaging and clinical trials services, has invested in item-level pharma serialization capabilities. The company was recognized for that effort and more during CPhI 2012’s European Outsourcing Awards (EOAs) with two awards. It was honored in the Best New Product category for its serialization solutions as well as the Outsourcing Executive of the Year category for SVP Global Commercial Services Peter Belden’s achievements during the realignment of U.K.-based Brecon Pharmaceuticals and U.S.-based Anderson Packaging to become AndersonBrecon earlier this year. “We are delighted to be recognized with wins in two categories in the prestigious EOA awards,” says Belden. “Throughout the year we have worked with diligence to build the foundation for a truly global healthcare packaging partner, while still, most importantly, maintaining the staff, expertise, commitment, knowledge-base and warmth that our customers have known and relied on for many years.”

Almac Invests in New Blistering Technology 

Global contract services provider Almac (www.almacgroup.com/commercial-services) has expanded its MHRA/FDA approved commercial packaging facility in the United Kingdom thanks to a Noack N 623 blister packaging line from Romaco. The company expects the line to offer flexibility for larger blister sizes and multiple-unit blister formats.

The system can be configured to process both thermoform and coldform materials, with maximum blister sizes of 220 x 155 mm.
“Blister size and dosage formats are becoming increasingly more complex. Additionally, product handling for innovative new molecules often requires enhanced environmental controls.

This investment allows Almac, through its Pharma Services business unit, to offer this additional flexibility,” said Geoff Sloan, vice president of manufacturing operations, in a statement. “Through this acquisition, coupled with our entry into the United States commercial packaging market, we continue to expand our capabilities and flexibility to meet our client’s needs.”

Added Bernd Webel, sales director for Romaco, in the statement: “The blister technology from Romaco Noack offers high OEE values and low lifecycle costs. Product changeovers are carried out easily and cleaning is quickly done. Our machines prove themselves flexible in operation and versatile in use.”

Also recognized during the EOAs was contract manufacturer Vetter (www.vetter-pharma.com) with first-place honors in the category of Most Improved Manufacturing Project or Process. The company’s new high-speed syringe filling line, located in Ravensburg, Germany, can produce up to 1 million syringes a day. Vetter and Bosch Packaging Technology developed a fully automated spray disinfection tunnel, processes, and systems for the safe aseptic transfer of tubs into higher cleanroom areas along with a filling station featuring flexible equipment for various production processes. (In 2007, the entire Ravensburg Vetter South facility won an EOA.)

Explained Vetter managing director Thomas Otto in a statement: “In order to meet the high demand of our customers as well as the increased regulatory standards today and in the future, Vetter made the decision to invest in an entirely new filling line.”
Vetter has also expanded in Chicago, building a state-of-the-art facility to support development of early-stage products for use in clinical trials, the company reports. 

Aesica Pharmaceuticals (www.aesica-pharma.com) is a contract developer and manufacturer of pharmaceuticals that has invested in anti-counterfeiting technologies as well as what it calls “sustainable” blister packaging.

“Blister packaging in particular is a lucrative market and one that has greatly improved patient adherence and enhanced drug authentication,” says Jeremy Drummond, PhD, business development director, formulated products, at Aesica. “Contract
manufacturers of blister packaging need to work hard to stand out from the competition; if they can offer something their competitors can’t, the opportunity to establish a presence in the North American market increases substantially.”

SECURING THE SUPPLY CHAIN
Service providers are serving up more than ever. “Outsourcing service providers absolutely have a larger part to play than just simply following a brief,” says Belden. “It is important that customers are fully advised every step of the way as to which solution would meet their needs best and how this could be implemented most effectively in-line with their requirements and existing processes. The expertise that outsourcing companies are able to provide is second to none, often drawing on decades of experience in their speciality field.”

In packaging, for instance, “specialist partners are able to provide a wealth of expert knowledge across a range of solutions,” continues Belden. “For example, if a customer comes to us with a drug that is unstable in specific packaging, we would advise them as to which techniques would work best to keep the drug stable in both pack and distribution. With a variety of factors known to affect the stability of drugs, it is important that contract packers provide the knowledge, advice and specialist facilities to help customers chose the best suited packaging to their needs.”

AndersonBrecon’s approach to serialization demonstrates its desire to educate its customers while fulfilling their needs. “The increasing occurrence of counterfeit medicines in the pharmaceutical industry and the promise of regulations that are to be introduced in the next few years means that companies are increasingly recognizing the need to implement secure track-and-trace solutions to protect the pharmaceutical supply chain,” explains Belden. “As a result, innovative serialization technologies are now being created and implemented in order to fulfill this need.”

AndersonBrecon invested a large amount of time and money into developing its serialization solution, reports Belden. “The risk that counterfeit drugs present the industry with is substantial, with many counterfeit drugs containing very little or none of the active ingredient, often incorrect ingredients, and potential toxins. This presents not only a major health and safety risk, but also puts the entire pharmaceutical supply chain at risk. The development of our serialization technology, which allows tracking and tracing of individual packs, is a result of our commitment to both patients and the safety of the supply chain.”

Belden continues: “On top of this, we are thrilled to receive acknowledgement of our serialization technology [through the Best New Product Award in the EOA], something that we strongly believe will provide a solution to one of the industry’s biggest and most documented challenges.”

Addressing the anticounterfeiting challenges in packaging design, Aesica has recently designed anticounterfeit packaging for one of the world’s largest pharmaceutical companies, enabling it to comply with stringent regulatory requirements brought in to protect and improve patient safety, the company reports. It refers specifically to the amendment to the European Directive EC/2011/62/EC requiring that outer packaging contains safety features that ensure the full authenticity of drug products; by law, such features must be implemented by 2016.

Christian Gross, head of packaging design technology and artwork services at Aesica, explains: “In one such patient-friendly solution we produced boxes that are tamper evident by design and enable patients to tell at a glance whether the products concerned are authentic. This system also includes Data Matrix marking, complete with batch numbers, expiry dates, and optional product codes, which enable full serialization. It was decided that Data Matrix marking provides a reliable system and a good alternative to the drawbacks of RFID approaches, which occupied too much space on the pack and were cost prohibitive on this particular project. In fact, Data Matrix is often far better than using reactive ink, which has proved especially unreliable as a security measure.”

The Aesica solution incorporated designing hologram labels into the side panels to combine visual safety characteristics with the option of hidden micro text features. “In fact, hologram is often far better than using reactive ink which has proved especially unreliable as a security measure,” Gross reports.

Gross adds that increasingly, his customers “are looking for multiple safeguards against counterfeiting that don’t compromise patient compliance.
“Balance is key in designing packs that are practical, workable and cost-effective on the production line and reassuringly protected against unsafe counterfeits,” Gross concludes.

FOCUSING ON SUSTAINABILILITY
Aesica offers outsourcing services from product formulation to commercial supply. Established in 2004 after a management buy-out of BASF led by CEO Dr. Robert Hardy, Aesica later acquired manufacturing sites from UCB that significantly expanded the company’s packaging capabilities. One of these is PP monoblisters in which the whole blister package is made from 100% polypropylene.

“The PP monoblisters combine the usability of PVC with a 100% recyclable profile and reduced emissions in combustion, which supports the ongoing pursuit of sustainable manufacturing by pharmaceutical companies,” commented Drummond. “This is an eco-friendly and fully printable alternative that enables brands to differentiate mature products or those fighting for retail shelf space in a crowded market, whether they be prescribed or over the counter drugs. We are one of only a small minority of manufacturing partners to offer PP monoblisters and we believe passionately that it is a proven route to more sustainable innovation in blister packaging.”

Dr. Franz-Josef Kohlenberg, the packaging expert who holds the position of Aesica’s operations director, in Monheim, Germany, explains: “We see a trend toward customers asking for alternatives for materials such as PVC and PVdC. Polypropylene can be recycled much more easily than PVC can, and it can also be landfilled or incinerated without the issues surrounding PVC.” 

Kohlenberg adds that “PP is much less energy consumptive at lower material costs than other blister packaging materials and offers higher or even comparable vapor barrier, and therefore supports the industry’s drive towards efficiency and
sustainability.”

With packaging lines in place with the capability to produce 600 PP monoblisters per minute, Aesica currently produces millions of blisters every year.

Kohlenberg says that it took some effort to get there. “Working with polypropylene requires a sophisticated forming process of preheating before sealing. It demands a combination of mechanical and hot air forming involving dedicated line tooling,” he says. “Aesica currently has five PP packaging lines in place in one site and can expand to other sites if demand supports it,” added Kohlenberg.

CONTINUED INVESTMENT AND GROWTH
As to the challenges that outsourcing companies themselves face, AndersonBrecon’s Belden says that “while outsourcing clearly presents a beneficial opportunity to pharmaceutical companies, specialist outsourcing providers are still under pressure to convince their worth to large pharma.

“With ever shrinking budgets, outsourcing companies must demonstrate the added value they bring to operations through their professional knowledge, skilled staff, and cutting-edge equipment and facilities,” continues Belden. “In addition to this, ever-changing requirements in such a heavily regulated industry mean that outsourcing companies must remain on top of their game and continue to adapt and develop processes in-line with regulations.”

Belden says that continuous improvements across the entire business are necessary, along with regular equipment, facility, and service updates “to ensure that the highest quality standards are achieved and evolving regulatory thresholds are met each and every time.

“Outsourcing companies must be aware that their services are being outsourced as a result of their high-level expertise, knowledge, facilities and equipment; therefore it is essential that this is kept up to date and current in order to provide a competitive advantage and added value to customers,” concludes Belden.

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