West injects market with new medical containment products

EXTON, Pa.—West Pharmaceutical Services Inc., a global manufacturer of containment and delivery systems for injectable medicines, has developed a new elastomer formula for two of its stoppers that the company said increases reliability and safety in the packaging, containment and transport phases.

In addition, the company has launched a new line to its established AccelTRA component program, AccelTRA Select, which offers new configurations of stoppers and a 1-3 mL uncoated plunger, all in a 4031/45 elastomer formula, West said.

A company spokeswoman said customer input drove much of the design of the 4040/40 formula used in the LyoTec stoppers, available in 13 and 20 millimeter sizes.

"Customers are looking for elastomers that are compatible with a brand portfolio of current drugs that also address the tightening regulatory requirements for the future," she said.

Using design principles that minimize by-product formation, the spokeswoman said the 4040/40 formula stoppers reduce extractables and particulates in whatever medicine or biomedical product they are containing.

"These are two key customer challenges that we focused on during the development of the new 4040/40 formulation," she said.

Extractables, which can contaminate the product, mostly are generated by interaction between the biomedical products and their packaging over time, usually under extreme conditions such as the presence of strong solvents or elevated temperatures, according to the company. Extractables also can be caused by gamma-irradiation.

Specific extractables of concern include bromo oligomers, the spokeswoman said.

The AccelTRA Select line, which features new configurations of stoppers and a plunger all in a "new-generation" 4031/45 elastomer formula, is designed to improve the packaging and delivery process for generics customers, according to West.

This line, which West hopes to expand in 2020, offers both serum and lyo stoppers in 13 and 20 mm sizes, along with a 1-3 mL uncoated plunger.

"These new elastomer product offerings reflect West's deep commitment to innovation based on customer insights," said Karen Flynn, senior vice president and chief commercial officer with West Pharmaceuticals. "We aim to simplify their journey with drug packaging and delivery systems and help bring much-needed injectable medicines to patients more quickly and efficiently."

The company debuted the new products at a recent industry conference in Frankfurt, Germany.

West's customers include medicine manufacturers, injectable and otherwise, as well as those in research and development sectors, among many others.

"It depends where they are in the supply chain," the spokeswoman said. "When customers develop drugs, they need to have trust in their packaging and delivery systems. We work with customers all the way up through the lifecycle of the drug, to the packaging scientist."

Integrated Solutions Program
In other West news, the Exton-based company celebrated the one-year anniversary of its Integrated Solutions Program, what West calls a "comprehensive approach to drug containment and delivery system development."

The program is an all-encompassing approach that sees the customer—through either defined or customized packages—remain with West from product purchase to packaging and delivery, with West assisting the customer with industry regulations and time-to-market along the way.

Jen Riter, senior director of analytical services at West, said a number of trends are driving drug and device manufacturing.

"The continued focus on combination products, as well as many pipelines containing complex molecules, are just a few examples," Riter said.

And as companies face gaps in experience and knowledge, the Integrated Solutions Program affords West the opportunity to fill these gaps.

Riter said it takes collaboration between manufacturers and external providers like West to ensure a product makes it to the market.

"We always knew smaller pharma companies could benefit from this type of bundled solution because they simply don't have the internal resources to accommodate the full range of services West offers," Riter said. "But we were excited to learn how many larger companies were willing to engage us in conversations about how we could help."

According to its website, West was founded in 1923, has 7,700 employees worldwide and 3.3 million square feet of manufacturing space. The company posted $1.84 billion in 2019 sales.

West said it produces about 112 million units daily, with 25 manufacturing sites globally, including facilities in Pennsylvania, Florida, Michigan, Arizona, Germany, France, Ireland, Singapore, China and India.