AccelTRA Component Case Study: Reducing lead time and optimising cost

The Situation

Because of competitive pressures, generic manufacturers are under considerable influence to get their products to market quickly. With significantly higher quality expectations from regulators, and the need to ensure the quality and safety of medical products for patients, fast commercialisation of a new generic drug product can be a challenge. To meet these increasing quality standards and ensure a quick move to market, emerging generics injectable manufacturers needed flexibility and simplicity when dealing with drug containment and delivery.

The Challenge

Seeking to reduce lead time and optimise costs, a generic drug manufacturer reached out to West to learn more about the AccelTRA™ component platform. The company hoped to reduce the number of its elastomer SKUs by developing a deeper understanding of the AccelTRA component’s applicability to, and suitability with, its current drug product offerings and upcoming product lines. In addition, the company was open to exploring how a commitment to purchase a greater volume of a single formulation could reduce costs by enabling the reduction of the company’s on-hand inventory.

The Solution

From the beginning, the company was sceptical yet hopeful of the value they could realise by selecting AccelTRA components. Upon learning that the AccelTRA component program provided robust extractables data and optimised lead times for both samples and commercial quantities, the company realised not only six-week time savings associated with component testing but also a significant reduction in elastomer SKUs.

West Technical Services experts analysed the company’s molecular entities to understand which drug products would work best with AccelTRA components. Detailed analysis found a 95 per cent match with the company’s existing product lines. Because of this analysis, as well as the continued technical support provided by West experts and the potential cost savings, the company went ahead with its use of the AccelTRA component 4031 formula elastomers for the original drug product line’s containment needs and is now considering expanding its use of AccelTRA components for other product lines. Use of the AccelTRA component platform – including components, extractables data and collaboration with West’s technical experts – helped the customer realise significant savings, reduce elastomer SKU complexity, and increase speed to market.

If you are facing the same challenge to get pharmaceutical drug product to the market quickly, choose West AccelTRA™ Components Program.

Launched in March 2017, the AccelTRA component program’s high-quality 4031/45 elastomer formulation enables optimised lead times, extremely low particulate levels and can withstand multiple punctures. These features help to reduce patient risk and ensure the drug and its packaging meet strict standards for quality set by regulatory agencies. Through the AccelTRA component program, West can provide generic drug manufacturers with sample components for injectable drug packaging in as little as one week and commercial quantities in six weeks. Available globally, the high-quality components are offered either Ready to Sterilise (RTS) or Ready to Use (RTU), have an industry-leading extractables profile and meet United States Pharmacopeia (USP) and European Pharmacopoeia (EP) compliance requirements.

AccelTRA products are currently stocked in India to deliver speed to the local generic drug manufacturers.