An increasingly competitive environment, temperamental drug products, and the growing threat of counterfeiting have pharma and biopharma companies seeking packaging development partners that bring expertise to the table, bring operational flexibility, and still add value to their products. In addition to ensuring product safety, packaging trends today revolve around compliance, counterfeiting, and cost. Brand identity is also a major component sought after in packaging products, and the solutions that provide all of the above are even better. Packaging solutions have evolved right along with the increasing diversity of drug products to accommodate the latest industry needs.

Serialization technologies and track and trace are considered to offer the greatest level of protection in the effort to confront counterfeiting. In addition to primary packaging, secondary packaging, such as label safeguards, carding and cartoning, and tamper evident seals, can provide additional layers of product protection.

Packaging Trends
Patient–friendly compliance packs are highly sought after among packaging solutions. Coding and labeling for supply chain visibility, and packaging for sensitive and highly potent or toxic drugs, are also prevalent.

Compliance packs are helping to change patient behavior with packaging that attempts to address adherence to medications. Dirk Corsten, managing director of Uhlmann Packaging Systems L.P., said, “In an attempt to enhance patient compliance and ultimately patients’ health, we see more compliance packs on the market. Many studies have proven that compliance packs have a positive impact on patients actually taking their drugs as prescribed. The good old bottle is still the predominant means to pack drugs in the U.S., however, we are approaching a tipping point toward other more patient-friendly packs. Mix-ups are significantly reduced, patients don’t have to wait 20 minutes at the pharmacy, and they get better information on the pack itself. Patients certainly do not have 10 amber colored bottles in their medicine cabinet anymore.”

Another trend, according to Glenn Siegele, president of Omega Design Corp., is a desire to improve supply chain security by increasing supply chain visibility, which addresses risk management and improves marketing, compliance and rebate issues. “Coding on the bottom of bottles encourages an improved packaging process along the manufacturing line and provides opportunities to increase the overall security of the supply chain,” said Mr. Siegele.

Additionally, packaging solutions that provide multiple purposes, such as safety, compliance and cost effectiveness, are increasingly customary. Labels, for example, don’t just contain product information anymore. “Pharma and biopharma companies are looking for intelligent and cost-effective packaging solutions that meet diverse requirements, and that can be adapted to their specific needs. Sophisticated labels can offer special functionalities while decreasing the environmental footprint and helping to ensure drug and patient safety,” said Gene Dul, president of Schreiner MediPharm U.S. The company offers a padded label designed to protect glass vials during processing and shipping. The Pharma-Cushion label has a layer of foam on the label’s reverse side that wraps around glass containers, which helps minimize the risk of damage while being processed or during transport.

Environmental considerations are also impacting packaging trends. “Sustainable packaging is becoming an essential consideration, involving more socially and environmentally responsible production at every link in the supply chain. In fact, the ‘hottest’ trend today is lightening the packaging load to assist in lowering transportation costs and reducing the overall carbon footprint,” said Stuart Hunter, Packaging Design Manager at Almac Group.

Among the latest integrated packaging solutions is the concept to simultaneously promote brand identity, patient compliance, safety, and protection from counterfeiting. For example, Bilcare’s nonClonableID offers a unique fingerprint that can be integrated with products, ID cards and other documents to provide secure and reliable identification and authentication. Each package or product has a tamper-evident label containing one of these non-clonable fingerprints, which can then be authenticated through a reader. According to the company, the unique fingerprint is randomly generated and cannot be duplicated.

Ajith Nair, senior vice president of Global R&D for Bilcare Research, said, “Packaging is traditionally seen as a carrier or maximum to protect the medicine from environmental and other impacts. The new trend is to utilize packaging’s potential to create product differentiation in the market — to sell more through better compliance packaging and better communication — and to create a brand identity. Our Bilcare nonCloanable ID is proving to be a highly effective solution to achieve patience compliance and also an effective anti-counterfeiting solution.”

Anti-counterfeiting layers are a necessity in today’s market. “A single level, static solution has never been effective for anti-counterfeiting solutions, because counterfeiting can happen at various levels up to the final retailer. Therefore, multi-level, dynamic solutions that ensure end-user participation are the only way forward. Most of today’s solutions are focused on identifying the counterfeited medicine after the fact, rather than discouraging drug forgery by incorporating features that can be easily visible, detectable or testable by the end consumer,” added Mr. Nair at Bilcare.

Packaging Needs
Demands from pharma and biopharma customers have changed significantly over the years. The concept of traditional or standard packaging rarely applies and, in most cases, no longer exists. Packagers have had to keep pace with fluctuating client needs. “Our clients are seeking more flexible packaging solutions, with the utilization of late-stage customization replacing the traditional packaging process. This is especially true with niche/orphan drug products, with country-specific information being applied to the pack only upon receipt of order, resulting in reduced stock holding, reduced lead times, and increased market flexibility,” said Mr. Hunter at Almac.

Pharmaceutical packaging solutions attempt to overcome an array of challenges to satisfy customer needs. With more diverse drug products on the market, including highly potent and toxic drugs, sophisticated packaging solutions are needed to accommodate these drugs. “The latest generation of drugs are more potent and require more protection in terms of the packaging, as well as for the user. We see a growing number of full containment units on packaging lines. Also, we see nitrogen purge devices to protect the product from oxygen in the pack,” said Mr. Corsten at Uhlmann Packaging Systems.

Bob Mac, marketing manager at Sharp Corporation, remarked, “We should see more demand to package specialty products such as custom pen assembly, auto injectors, oncology drugs, toxic products, new nanotechnologies, and new delivery devices.”

Other areas where pharma and biopharma companies seek more advanced packaging solutions include specific product challenges for certain inhalable products and prefilled syringes. Mr. Corsten at Uhlmann Packaging Systems said, “This certainly applies to inhalable products where a micro-dosed powder is dispensed into a blister strip or a single dose. This type of blister is placed into a special device for inhalation. The way these products are packed is quite sophisticated and requires a significant amount of special engineering. Parenteral products are also packed in an advanced way. The use of prefilled syringes and pens are convenient for patients to use, so the higher investment in packaging is rewarded by patient satisfaction and better compliance.”

There are also industry needs for advanced packaging to accommodate moisture-, oxygen-, and light-sensitive drugs. Angela Roggenhofer, sales and marketing manager at Tekni-Plex, Inc., said, “More and more drugs are not only sensitive to moisture but are becoming sensitive over time to oxygen protection, so it’s important to offer the full film range to protect to the max degree any ingress of either Moisture Vapor Transmission Rate (MVTR) or Oxygen Transmission Rate (OTR) molecules or gases. Pharma companies also are looking at new high barrier alternatives to cold-form foil (CFF) packages. We’ve recently launched a 6mil PCTFE-Aclar barrier film to meet the demands in high humidity countries for non-CFF film packaging.”

Ms. Roggenhofer also noted, “Unit dose packaging for liquids, specifically solutions that meet UV product protection and that keep liquids contained without egress through the forming and lidstock web, is beginning to carry a high level of interest.” For this, Tekni-Plex offers a line of co-extrusion (cyclo-olefin copolymer) COC-based barrier film and universal lidding material to accommodate liquid fill/light-sensitive products in a blister format.

Combatting Counterfeits
Counterfeiting remains a profound challenge in the industry. Drugs can often take roundabout routes before reaching patients. An alarming example is the recent incident of counterfeit Avastin, Roche’s cancer drug, reaching patients. This represents a clear example of how easily the supply chain can be compromised. U.S. authorities have identified a distributor that may have allowed counterfeit cancer drugs to reach U.S. clinics. Also, according to authorities, the packaging did not match FDA-approved labels.

Pharmaceutical packagers must constantly innovate, as counterfeiters lie waiting to overcome many, or all attempts to impede them. “It is amazing to see how professional some counterfeited packs look and it’s exceedingly difficult to make a distinction between originals and counterfeits,” said Mr. Corsten at Uhlmann Packaging Systems. “Whatever we do in terms of packaging, such as invisible ink, holograms, etc., the counterfeiters will copy in a heartbeat.”

Staying several steps ahead of the game is essential. “Counterfeiters often have access to the same processing and packaging machinery as legitimate pharmaceutical manufacturers, so it’s difficult to distinguish fake from authentic. A robust brand security plan, which incorporates many tools to identify legitimate product and packaging, is an absolute must,” said Mark Feher Business Development Manager, Mettler-Toledo Hi-Speed.

In an effort to help secure the supply chain, a variety of anti-counterfeiting solutions and products are needed, and when layered, offer the greatest protection. Tamper evident and serialization technologies are often used together to help combat counterfeit products from reaching the market. Tamper proof materials address the problem of substituting legitimate drugs with counterfeit drugs while serialization addresses diversion, where legitimate products end up in an illegitimate market.

Additionally, packaging and labeling are critical to product authentication and offers a reliable barrier against counterfeiting and tampering. Mr. Dul of Schreiner MediPharm noted, “A recent development is the Pharma-Comb Void label that features integrated covert inscriptions, which helps eliminate the illegal practice of empty vials being refilled with fake drugs and then resold. The label is functionally destroyed during its initial use. When the label’s tear strip, which also runs around the closure cap, is removed, the inscriptions “opened” and “used” appear in two indicator fields. Thus, the undetected reuse of the vial with the original label is virtually impossible.”

Additional anti-counterfeiting features offered by Schreiner MediPharm include covert security technologies such as 2-D and 3-D holograms, color-shifting inks, guilloche and micro-text printing and thermochromic inks. Covert technologies such as LaserSecure for example, uses pigments that can only be seen by a special reader, or luminescent digital watermarks visible only to informed experts.

Mr. Corsten at Uhlmann Packaging Systems commented, “It seems that the only way to win this battle is with a proper track and trace system that can make clear distinctions at the point of sale as to whether or not a product has the proper pedigree and is therefore an original.”

In addition to meeting branding and anti-counterfeiting needs, packaging designs must comply with existing and what’s likely to be forthcoming e-pedigree regulations. Under current law, no wholesaler or pharmacy may sell or acquire any prescription drug without receiving a pedigree, or a record containing each transaction resulting from change of ownership. “The pending e-Pedigree law in California, we hope, will force the industry into significant change for the better.

There is a time pressure to meet regulatory deadlines in California — whose unit-level serialization laws begin taking effect on January 1, 2015 — and strained internal and external resources to meet timeline demands. The industry needs to seriously begin the process of ramping up for this game-changer,” said Mr. Siegele at Omega.

The pending e-Pedigree law in CA, along with similar legislation in the pipeline, should provide for increased accountability of the supply chain. As a result, ongoing development of industry standards has helped to establish what’s needed for interoperability and sharing of pedigree data and records. According to Mr. Feher at Mettler-Toledo Hi-Speed, “On the track and trace side, government regulations for product identification, more specifically serialization and the packaging systems supporting serialization, are the biggest advance in the fight against counterfeit drugs.”

Compliance, brand identity, product protection, and keeping costs down, are among the top priorities for pharma and biopharma companies seeking packaging solutions. Therefore, contract packagers must stay flexible and continue to advance solutions to address the evolving challenges counterfeiting and specialty products present. Packaging solutions now offer higher levels of sophistication that can be customized for the client. From serialization, coding and data management, to labels and tamper evident packaging, multiple products are likely to be a part of pharma packaging solutions. Along with the increasing diversity of drug products and the growing threat of counterfeiting, come advanced solutions that create multilayer barriers of protection.

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Kristin Brooks is the associate editor at Contract Pharma. She can be reached at kbrooks@rodpub.com