State of Packaging in the Pharma Industry

Changes stemming from regulations, technological innovation and discovery bring about challenges for brand owners, packagers and OEMs

By Jerry Martin, pharmaceutical and life sciences consultant to PMMI, The Association for Packaging and Processing Technologies

According to last year’s “State of the Industry: U.S. Packaging Machinery Report” by PMMI, the pharmaceutical sector is forecasted to have the fastest growth at a CAGR of 2.8 percent through 2020. On a global scale, the demand for pharmaceutical packaging products is expected to increase 6.5 percent annually to over $100 billion by 2019.

Each year the pharmaceutical landscape experiences changes stemming from regulations, technological innovation and discovery. With these changes arise new challenging variables for brand owners, packagers and original equipment manufacturers (OEM) to overcome. The year 2017 is no different as we see a number of ongoing changes in the pharmaceutical industry continue to take shape, including changes in pharmaceutical manufacturing and packaging standards.

For instance, manufacturers and their equipment suppliers are forging more partnerships for equipment validation. The adoption of a global regulatory track-and-trace and serialization system is gradually forming to combat counterfeit and gray market drugs. Research and development for packaging of complex biologicals and biosimilars is also continuing to evolve to meet the demands of a growing market.

MANUFACTURERS EXPECT EQUIPMENT VALIDATION
In order to eliminate process validation steps and reduce downtime between batches, biopharmaceutical manufacturers continue to adopt single-use, pre-sterilized flexible plastic containers as the gold standard for intermediate/bulk packaging of biopharmaceuticals. Due to the benefits of reduced development time for both validating sterilization and in-facility sterilization, and eliminating cleaning and cleaning validation, incorporating single-use equipment produces a cost effective and efficient pharmaceutical supply chain. However, the plastic packaging of single-use processing is not without its challenges.

Drug regulations for Good Manufacturing Practices (GMP) regard the pharmaceutical manufacturer as liable for any contamination or adverse effects from a drug that results from processing equipment. Therefore, now more than ever, pharmaceutical manufacturers are forging partnerships with single-use plastic packaging suppliers to conduct the initial characterization testing for extractable materials. Many in the pharma industry believe that because equipment manufacturers are the true experts of their components, such as plastic biocontainers, connectors, tubing and assembled systems, it would reduce end-user costs and regulatory hurdles by providing extractable testing as a data package. Otherwise, each drug manufacturer needs to spend up to half a year gathering data for regulatory approval, which can cost a moderately successful drug company millions each year in sales if there are any doubts about the single-use plastic packaging.

GLOBAL DEMAND FOR SERIALIZATION AND TRACEABILITY TECH
In a recent report by PMMI entitled “Pharmaceutical & Medical Devices Trends & Opportunities in Packaging Operations,” the counterfeit drug market was estimated between $75 billion and $200 billion. This is due in part to a global supply chain where a single drug can pass through several countries throughout the manufacturing process, providing ample opportunity for tampering. A pharmaceutical can be synthesized in one country, mixed with fillers in another and then packaged elsewhere before it even arrives on the shelf of a pharmacy in the U.S. Due to this surge in counterfeit drugs, track-and-trace regulation laws are being set in place in the U.S. and in Europe to reduce incidents of counterfeit or grey market drugs.

The U.S. enacted the Drug Supply Chain Security Act (DSCSA) in 2013 to increase consumer protection from fake drugs requiring manufacturers, wholesalers and packagers to collect and share receipts of all transactions. In fact, by the end of 2017, all manufacturers will need to begin introducing a serialization track-and-trace system capable of identifying the smallest saleable unit and case level with a product identifier, serial number, lot numbers and expiration date. Packagers, however, will need to be prepared to introduce these technologies by the end of November 2018.

PACKAGING THE GROWING BIOSIMILAR MARKET
In 2014, the global biosimilar market was estimated at over $2.5 billion and surpassed $3.3 billion during 2016. Looking forward, the market is forecasted to exceed $10.5 billion, growing at a CAGR of about 25 percent from 2017 to 2023. With the market forecasted to grow exponentially, packagers and manufacturers will need to stay ahead of challenges to remain competitive.

The packaging of biologicals, including biosimilars, requires special attention considering the complex makeup of these drugs. For the most part, large molecule biological and biosimilar protein drugs are injectable liquid dosages. However, due to the variability and complex nature of biosimilar properties, leachables like metal ions or organics, or silicone lubricants, can change the shape, stability, activity or immunogenicity of the protein drug. These changes can ultimately cause adverse effects in patients — a risk that places the utmost emphasis on acquiring the safest packaging. Each biosimilar will require different precautions and react with packaging differently; therefore, partnerships with suppliers when searching for proper packaging is critical.

HEALTHCARE PACKAGING EXPO & PACK EXPO
This year’s Healthcare Packaging EXPO, co-located with PACK EXPO Las Vegas (Sept. 25-27; Las Vegas Convention Center) will provide attendees the opportunity to liaise with thought leaders and learn industry insights from the producers of innovative healthcare packaging technologies. The event, produced by PMMI, will convene 2,000 exhibitors presenting demos on the floor and 30,000 packaging industry professionals. Additionally, the show features education sessions on regulatory matters and pharmaceutical, biopharmaceutical and healthcare business trends at the Innovation Stage.

For more information on solutions and to register, visit hcpelasvegas.com.

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