Complexity is everywhere in today’s fast-changing world, but outside high tech, there are few industries where the ground rules, the products and the market sare shifting as fast as in pharmaceutical packaging. Bursting the envelope - er, blister pack - is an exploding array of new drugs and drug delivery formats, many of which need new ways of presentation and packaging. At the same time, regulators in the United States and Europe are taking a more active stance in deciding how drugs can be packaged and shipped to domestic and global markets.
These changes, combined with the growing trend of pharmaceutical firms to outsource nearly everything but R&D and marketing, have opened the door for contract firms to take a lead role in packaging innovation.
Contract packagers are providing much of the innovation in how many new drugs - as well as traditional remedies - are brought to market. “As manufacturers shift more volume to contract packagers, they are going to be looking for their partners to bring more innovation to packaging,” says Matt Rayner, executive director of operations at Legacy Pharmaceutical Packaging, a contract packager based in St. Louis, Missouri.
Also contributing to this contract packaging boom is the move toward smaller, more flexible production lines in response to demand for personalized medicines and smaller batch sizes. “With big pharma increasingly outsourcing R&D, process development and manufacturing, including packaging, the entire contract arena is growing,” says Jerry Martin, pharmaceutical and life sciences consultant for the Association for Packaging and Processing Technologies (PMMI). Still another factor is the reliance on contract manufacturing by small biotech firms, which tend to have limited investment in infrastructure.
In many instances, the contract packagers’ role has expanded to include designing and manufacturing the packaging, filling the packages and shipping the finished product to the pharmacy, HMO or other buyer. In effect, they’ve become the hired gun of the industry, taking on a host of challenges that pharmaceutical manufacturers would prefer to off-load, allowing them to both reduce costs and concentrate on the business of developing and bringing new drugs to market.
“As a contract packager, we provide a full turnkey operation for our customers by sourcing all of the components from our vendors, packaging the drug into its primary and secondary packaging, and when required, serializing the product to track and trace it through the supply chain,” says Joe Luke, vice president of sales and marketing at Reed-Lane, a midsize contract packager. “We work with virtual customers to design a package that matches their ideas with what our packaging engineers know our lines are capable of.”
INDUSTRY EXPERTISE FOR HIRE
Ultimately, contract packagers must confront largely the same battery of challenges as the pharmaceutical industry overall - only they must be able to shift on a dime to accommodate the varying packaging needs of manufacturers whose drugs range from self-administering biological treatments in prefilled syringes to glass vials to pills in blister packs.
As a by-product of having to deal with all manner of product developed by the industry, contract packagers tend to have built up extensive expertise in dealing with issues such as serialization, anti-counterfeiting measures and tamper-evident packaging - all capabilities attractive to big pharma.
“The anti-counterfeiting activities - primarily tamperevident packaging and serialization - fall directly in the domain of contract packagers for expertise,” Martin asserts.
“Pharmaceutical companies are taking more advantage of contract manufacturers as a way of reducing costs and expanding their capabilities to take advantage of the new packaging technologies the contract manufacturers are developing,” Martin explains. “The big pharma companies are not set up to deal with these emerging markets, and they are going to avail themselves of the packaging and distribution chain that the contract companies already have in place and available on a global basis.”
There are obvious cost savings. Revamping a packaging line every time a new drug or family of drugs is introduced can be far more costly than outsourcing the new product from the get-go. “A lot of manufacturers are looking to outsource more and are relying more on contract packagers because they don’t want to invest in modernizing an older packaging line,” Rayner says.
The contract packaging market had revenues in 2016 of about $9 billion, Martin says, and it’s growing at about 7 percent per year, with a projected revenue total of $15 billion by 2022. The global expansion of the drug market is one factor spurring this growth. The other big factor driving contract packaging is the cost pressures facing pharmaceutical makers. “By contracting out manufacturing and packaging, it’s a lot cheaper - you don’t have to invest in all the equipment yourself,” he adds.
Such emerging trends as single-use or modular manufacturing that enhance the flexibility of manufacturing operations often are best suited to the new, smaller-volume vaccines and other biological treatments. “Companies are looking at adopting single-use manufacturing because it allows them to produce at whatever scale they need,” Martin points out. “For formulation, filling and packaging, these flexible operations allow them to contract out at the scale they need. It gives the drug companies the flexibility to concentrate on their core competencies and avail themselves of the new technologies in packaging from contractors.”
SERIALIZATION ON DECK
Serialization continues to loom large, although most contract packagers have their hands full meeting today’s regional market requirements. “Serialization is not an immediate requirement, because much of the marketing is regional,” says Martin. “Nonetheless, it still has many technical and regional challenges.”
While ensuring protection against counterfeiting and tampering, serialization also will help bring about a level of supply chain security on a global basis that so far has yet to be achieved. “Supply chain security is going to be required,” Martin says, “so being able to provide it will be critical. Pharmaceutical manufacturers unable to address serialization and product track and trace requirements ultimately are not going to be in business.”
Of course, many of the larger contract packagers already are gearing up for serialization’s eventual global requirement. “We invested in serialization early on, so we’re well equipped to meet upcoming regulatory requirements for unique identification of drug products,” says Gaurav Banerjee, director of technical services & enterprise applications at Sharp Packaging Solutions.
The major global contract packaging companies all have the technological capability to implement serialization at least regionally. Global serialization will be established once harmonized standards have been approved by the appropriate regulatory agencies for different markets, Martin says. “The big packaging suppliers will become broader in their offerings and maintain their global approach,” he adds. For example, Sharp Packaging Solutions, as part of a global firm, UDG Healthcare, Plc, operates facilities in the U.S., UK, Belgium and the Netherlands.
Martin believes it may take a while longer before global standards have been fully adopted and implemented. For example, he says, serialization poses challenges, “both from the physical space the information requires on the label to differences in national/regional standards.
“We’re still in the innovation stage, but perhaps in 5 to 10 years there will be harmonized international packaging and labeling standards so products can be shipped anywhere in the world,” Martin continues. “Right now, serialization and other labeling requirements have to conform to where the product will be shipped. But the big producers want to be able to sell on a global basis, and they don’t want to have to be changing labeling because of regional differences.”
DESIGN AND INNOVATION
With change being the name of the game, contract packagers must be capable of not only responding to the needs of pharma companies, but taking a lead role in creating new forms and styles of packaging. This kind of innovation in packaging is one way contract packagers can gain a leg up on the competition. “We have a well-developed design service offering that provides options to our customers for compliance and counterfeiting prevention,” says Banerjee.
Having a design capability in-house is essential for contract packagers when dealing with the small, fast-growing biotech firms that often lack the various skillsets, production capabilities and supply chain networks needed to bring new products to market in innovative packaging.
“The packaging challenges become even greater for virtual pharma companies and biotech, with the need for multi-component kits comprising vials, prefilled syringes and auto injectors that must be presented in a staged format,” Banerjee adds. “Our design team is regularly challenged by clients for designs that are intuitive to use for physician and patient, are commercially viable to produce and that enhance patient safety.”
As examples of innovation in packaging, Banerjee points to Sharp’s child-resistant packaging and its five-level aggregation of serialized product, from individual blister cavity on a card, to blister card, to carton, to case, and finally to pallet.
However, innovative packaging alone does not, by itself, ensure widespread industry adoption. “Given the regulatory issues and the fact that a new technology has to be approved by the FDA in the U.S. or other regulatory body overseas, there is a reluctance on the part of drug manufacturers to implement a new technology if it’s going to take longer to get the product to market,” Martin adds. “It will cost more and take more time to get that drug to market with an innovation in packaging.”
In some cases, the development of a new drug or family of drugs in itself can help spawn an innovative approach to packaging. “Innovation in packaging is largely tied to formats and dosing,” Banerjee says. “As there are new ways of getting effective treatments to patients, there will have to be new packaging methods to go along with those advancements.”
“Innovations are coming from the packaging material, equipment and software suppliers - coordinating laser printed labels with filling lines, post-fill secondary packaging and labeling,” adds Martin.
“We are an extension of the manufacturer,” says Rayner. “For example, we have to be able to connect with their IT systems for serialization. We are always trying to find an innovative solution for the customer,” he says, adding that the company has an engineering group that works with customers to develop packaging designs.
“There are a lot of innovative packaging designs and concepts, but the difficulty is in making them cost-effective,” says Brad Rayner, vice president of sales and marketing at Legacy Pharmaceutical Packaging and the brother of Matt Rayner. “We were the first to launch our Ecoslide-Rx package, a child-resistant compliance pack that helps ensure patient compliance” with a daily dosing reminder on the box. Another new design was the company’s dispensing carton, a prepackaged aid to the pharmacist that enables faster, more accurate dispensing of the prescribed number of tablets in a bottle or carton.
From an innovation standpoint, Martin envisions advances in packaging designed to ensure greater stability of protein drugs. “We’re already seeing a switch from siliconized glass vials and rubber stoppers to new glass formulations and fluoroelastomeric coatings that eliminate silicon and glass contamination, reduce leachables from stoppers and minimize protein adsorption/desorption interactions.”
An updated standard for extractables and leachables from pharmaceutical packaging has been published for polymeric primary packaging by USP (661), Martin notes, and a new standard for determination of extractables from polymeric process equipment (USP 665) will be published later this year.
In other words, stay tuned, you haven’t seen anything yet...