PACKAGING SERVICES

For Barrier Therapeutics, contract services are vital to its business. “We don’t do any of our own manufacturing or packaging,” reports Scott Rizzo, vice president of supply-chain management and trade relations. “We outsource everything.” The firm’s core competency lies in marketing and developing proprietary thera­peutic dermatology products. “Not packaging,” says Rizzo.

The dermatological products company was founded by Geert Cau­wenbergh, PhD, CEO of Barrier Therapeutics, on technology that Cauwenbergh had created while serving as a vice president for Johnson & Johnson Consumer and Personal Care Products Companies. (Barrier Therapeutics acquired the intellectual property owned by J&J and its companies.) Products include Vusion, a treatment for diaper dermatitis complicated by candidiasis; Xolegel, an antifungal gel for seborrheic dermatitis; and Solage, a treatment for age spots.

Barrier Therapeutics relies on its contract manufacturers for packaging its products into standard formats, reports Rizzo. These include squeeze tubes for Vusion and Xolegel and a bottle-and-dropper combination for Solage.

With the help of contract services providers, Barrier Therapeutics is also eyeing novel packaging formats that could “improve a patient’s experience with a product.” As he explores new packaging options, Rizzo says that he is intrigued by ideas brought forth by contract packagers like Catalent Pharma Solutions (Philadelphia). “We are speaking with Catalent about technology advancements with individual dosage forms,” he says. “Its DelPouch, for instance, offers patients benefits such as convenience.”

Contract packagers like Catalent are being called upon more often these days to do more than just fill and seal a package. They are consulting on packaging design and helping build package security programs, among other tasks. Akan Oton, global director of marketing for Catalent’s Packaging Services segment, says that his company is being asked to help with compliance-aiding packaging designs, electronic pedigree mandates, and cost-saving initiatives, for instance. Primarily a provider of dose-form manufacturing and packaging, Catalent also offers proprietary package designs that aim to make child-resistant compliance packaging affordable. One such option is HingePak, says Oton.

Alcan Pharmaceutical Packaging’s Contract Packaging and Specialty Cartons division (Bethlehem, PA) is also responding to requests for more than just traditional contract packaging services. “Alcan holds package design as a paramount service offering among its competencies,” says Daryl J. Madeira, director of marketing. “While we have substantial, efficient capabilities surrounding bottling, blistering, cartoning, and other common packaging formats, we often are brought into projects, both new and existing, to help find a packaging solution for a challenging packaging format.”

As both a contract manufacturer and packager, Tapemark (West St. Paul, MN) is extremely involved in package design, says Julie Karlson, marketing manager. “We can offer suggestions that will make the entire process of manufacturing and packaging the product most efficient.”

Tapemark’s “focus is on single-dose formats such as a pad, patch, or gel.” Karlson points out the firm’s exclusive license for Snap! packaging for dispensing a premeasured dosage of prescription and over-the-counter pharmaceutical lotions. In addition, Tapemark converts soluble film, cutting and packaging individual or multiple strips (depending on dose) into single-use packaging.

Carton Service—Packaging Insights (Norris, TN) is involved in “packaging design” on nearly 100% of its packaging opportunities, reports Reid Lederer, president. “As we have in-house structural and graphic design services, CS-PI frequently offers alternative designs or new innovations. These services are provided to our customers with intentions of helping them grow their market share and enhance their brand equity.”

Staff from contract manufacturer Surefil also par­ticipate as members of customer packaging design teams, says Bill Hunt, CEO and founder. “We are the ‘design for manufacturability’ piece. This includes looking at how to handle unique bottle shapes at speeds of up to 280 bottles per minute, how to apply custom caps, and orient bottles, caps, labels, and the like. We also perform technical tests to ensure that the bottle can fit enough product to make label claims, that the labels are the correct size, and so forth.”

DELIVERING DRUGS

As companies like Barrier Therapeutics consider the role that packaging can play in drug delivery, contract services providers are being asked to develop solutions that suit individual products. For instance, Vital Pharma (Riviera Beach, FL) can adjust the flow and drop size of the drug product with creative designs for container shape and functionality. “This is particularly important when filling and dispensing ophthalmic drugs down to a single drop,” points out Robert B. Gettis, in corporate development for Vital Pharma. In addition, “in the area of sterile processing, many companies are looking at unit-dose preservative-free products for the eye and for inhalation drugs. We are investing in continuous improvement and innovation to address this trend.”

Vital Pharma is “working with customers earlier in product development. We are being asked to coordinate the development and analytical services required prior to filling a product using our blow-fill-seal machinery,” says Gettis.

Catalent also provides blow-fill-seal aseptic packaging technologies, with a variety of patented designs and manufacturing approaches at its blow-fill-seal facility in Woodstock, IL.

Madeira adds that Alcan Packaging has also been “adding competencies surrounding unique drug-delivery systems that require unique packaging services.”

Vital Pharma and other contract packagers are often guiding material selection for novel packaging. “We are almost always asked to recommend the resin,” says Gettis. For blow-fill-seal applications, “there are a limited number of resins used, and selection is often determined by the size of the container.”

Tapemark is also tapping its experience in sourcing packaging materials. “While some customers come to us with preselected and qualified materials, most will rely on our expertise to source and recommend the total package solution,” reports Karlson. “We often recommend cost-effective alternatives that meet product barrier requirements. If desired material characteristics are not readily available off-the-shelf, we can laminate multiple layers together to provide materials that meet requirements.”

EQUIPMENT AND MORE

Contract services companies are also making the necessary capital investments and forming strategic partnerships to add value to their service lineups. “One of our strengths is the ability to assist our customers by offering in-house design and manufacturing of the required tooling,” says Gettis of Vital Pharma. “We start out with prototype or stock tooling, but we help companies on every new product with the final design of the container.”

Catalent has invested in what it calls state-of-the-art vision inspection systems for its printed components facility, says Oton. And the firm’s partnership with Secure Symbology also adds another option for Catalent customers looking to add serialized bar codes to printed materials or packages.

Alcan maintains a DEA-regulated vault that is registered for Class II through Class V controlled substances as well as a cold-storage facility at 2–8°C for handling large-molecule entities that demand cold storage as either incoming bulk or finished goods. Madeira is seeing increased demand for cold-chain solutions.

For producing secondary packaging, Magellan Packaging (Hampshire, UK; San Jose, CA) offers a number of resources and services, such as a full design studio; media duplication, printing, and fulfillment; and warehousing and distribution, says Georgina Pearce, marketing manager. “Our electronic collateral ordering solution enables our clients to order their products through a secure Web store,” she adds.

Registered with FDA as a secondary labeler and packager, Diamond Contract Manufacturing (Rochester, NY) maintains a full-service creative design department with structural and graphic designers. “We are capable of stepping in at any point in the process to help our clients meet their packaging design needs,” says Jason Aymerich, sales manager. “We find that our customers rely on us to understand the most efficient way to manufacture packaging that has relevance in the marketplace.”

CONTROLLING COSTS—TOGETHER

When working with contract service providers to consider novel packaging formats, Rizzo is mindful of the bottom line. “Cost is always something you are going to have to consider. There could be some competitive advantages to using a new packaging format—but you have to determine whether it is worth the cost.”

Aware that pharma companies are concerned about costs, contract services organizations are keeping an eye on them, too. “Cost pressures are affecting the entire industry,” says Oton from Catalent. To address them, Oton says that his company is focusing on operational excellence by building a Six Sigma program and driving lean manufacturing across its entire organization. “We are looking to add 100 black belts (which could be current employees) across all our facilities, and more than 10% of our more than 10,000 employees have been trained in the principles of Lean and Six Sigma,” he says.” The goal is for Catalent to achieve on-time delivery of quality products using proprietary technology and expertise, he adds.

Tapemark has embraced continuous improvement and lean manufacturing, says Karlson. “We are now offering consulting to our customers in what’s called a 2P or 3P kaizen event. A kaizen event, typically lasting several days to a week, offers a concentrated problem-solving focus with Tapemark experts. In a 2P event, Process Preparation, we focus on how to manufacture your product as efficiently as possible. In a 3P event, Product and Process Preparation, we work together up front to design the product with manufacturability in mind. Both 2Ps and 3Ps can jump-start the development cycle by several months or more, enabling your product to reach commercialization into your markets much faster.”