Packaging Becomes Enabler for Biopharmaceuticals

Packaging is no longer selected in the last stages of drug development and commercialization. A recognition that the appropriate choice of packaging can impact not only the marketability of a drug, but also aid in theft-prevention and patient compliance, has led to the consideration of packaging as an integral component of final formulated biotherapeutics. At the same time, advances in packaging technologies are creating opportunities for greater product differentiation and better management of products across the value chain, according to an analyst from market research firm, MarketsandMarkets.

Continued growth expected
The demand for pharmaceutical packaging is expected to increase as biologics manufacturers seek new methods for protecting and promoting their products, increasing patient compliance, and meeting new regulations. MarketsandMarkets estimates that the global pharmaceutical packaging market will grow at a compound annual growth rate (CAGR) of 6.7% from 2013 to 2018, reaching a value of $78.8 billion (1).

It should be noted that this value includes drug delivery systems that are also considered to be product packaging. This sector of the packaging market is growing at an even faster CAGR of 9.1% due to increasing demand for delivery/packaging solutions as numerous small-molecule and biologic drugs come off-patent in the coming years, according to MarketsandMarkets.

Specifically for biopharmaceuticals, the fastest growing packaging types are prefillable syringes and parenteral vials, which are required to meet the packaging and delivery needs of new biologic drugs that must be injected. Other areas of the pharmaceutical packaging market seeing the greatest growth include labels and accessories, blister packs, temperature-controlled medicines packaging, and select niche products.

MarketsandMarkets cautions, however, that both biopharmaceutical manufacturers and packaging suppliers must be aware of raw material availability,  price volatility issues, and changing health regulations that may impact the industry. In addition, pharmaceutical packaging must increasingly be designed such that it is appropriate for use in many different geographical markets and reflects a consideration of sustainability  (2). Furthermore, according to MarketsandMarkets, biologics companies should also note that consolidation among global pharmaceutical packaging suppliers has enabled leading firms to strengthen their presence, particularly in emerging markets.

New vial and syringe technologies
A packaging technology attracting growing attention for parenteral products is blow-fill-seal (BFS) technology, in which plastic vials (or other containers) are formed, filled, and then sealed in one continuous process. Aseptic BFS systems fill sterile product and are performed in a controlled, sterile environment. BFS systems are attractive for many biopharmaceuticals because they not only offer both low-cost packaging and sterility assurance with minimal human intervention, they are also suitable for biologics that cannot withstand the high temperatures required for terminal sterilization  (2).

The increasing interest in BFS technology parallels the increasing demand for prefilled syringes, which provide both ease of use and convenience along with increased safety and reduced drug overfill, which can occur when administering a product using a vial and syringe. Prefilled syringes are, in fact, being used for both new products and to switch the delivery mechanism for products already on the market  (2). Separately, increasing numbers of patients in hospitals and nursing homes are receiving their medication in unit-dose vials that provide a single dose in a disposable package. One advantage of these vials is that any unused doses can be returned to the pharmacy  (2).

For products that must be maintained in a hermetically sealed ampoule to prevent exposure to air and/or moisture, there have been advances in ampoule technology that increase their safety, including ampoule that break more readily and with greater control, and devices that can be used to break the ampoules and keep humans hands from being exposed to a risk of injury  (2).

Preventing counterfeiting
Other new packaging technologies attracting interest have been developed to prevent counterfeiting of drug products. Tamper-evident packaging systems include specially designed film wrappers, shrink seals and bands, caps that must be broken to access an internal seal, and sealed tubes that require puncturing  (2). For parenteral formulations, with two-in-one prefilled vials, which have the water and active ingredient in separate chambers designed to allow mixing prior to use, it’s easy to detect tampering  (2).

Some companies may use hidden features on labels, such as fluorescing fibers or chemical reagents as encrypted text visible only under special light, while others choose to use watermarks or metallic threads as an optically variable device with images that flip or transition. Radio frequency identification (RFID) tags are also used to track drug products  (2).
Functional security labels are also finding increasing use, including holographic labels, specially cut paper labels that only tear off, labels made of cellulose acetate or vinyl films that fragment when removed, and self-adhesive labels that, when removed, exhibit the word VOID (or another word) in the adhesive and the removed film  (2).

New ink jet coding, laser coding, and metal electrolytic etching technologies are also being employed as anti-counterfeiting measures because they enable rapid, flexible, online coding at reasonable cost, particularly due to the use of digital printing techniques  (2). Color-shifting inks (formulated with special pigments) that appear to change color with the viewing angle are increasingly being used in security seals due to the ability to control the details of the color change. Pharmaceutical packaging companies also offer anti-counterfeiting technologies based on forensic markers, such as trace chemicals and biological compounds that can only be detected when using specially designed test kits or in the laboratory  (2).

References
1. Drug Delivery Technologies Market – Global Forecasts to 2017, Markets and Markets, April 2013.
2. N. Zadbuke et al, J. Pharm. Bioallied. Sci., 5(2), 98–110 (2013).