The pharmaceutical industry has seen a significant rise in the development of injectable drugs, with these drugs now making up a majority of the clinical pipeline. Biopharmaceutical companies are increasingly turning to combination products and outsourcing drug handling, fill finish, and device manufacturing. This has created a demand for contract manufacturers to support the assembly, packaging, and kitting of combination products for clinical builds.
As a leading vendor of primary packaging components and contract services, we have listened to our customers’ needs for a pre-qualified, flexible drug and device assembly solution that can save time and capital, streamline the supply chain, and de-risk the process in the pre-launch and early commercial phases of drug development. Customers have expressed a desire for a comprehensive offering that includes cold chain storage, design verification support, release testing, packaging design, and shipping to the next stage of the drug workflow.
To address these needs, we have developed a flexible assembly and packaging cell set to be operational in Q1 2026. Housed in a Class 8 ISO cleanroom, this cell is capable of handling all the necessary steps to support clinical and early commercial volumes of pens and autoinjector drug delivery devices. This includes final assembly, labeling, cartoning, check weigh, serialization, and aggregation.
The cell is equipped with analytical testing capabilities to verify the identity of incoming drug products and perform mechanical tests to assess device performance. These tests include activation force, drop and breakage, dose accuracy, needle shielding length, cap removal force, and more.
In summary, our service capability aims to provide biopharmaceutical companies with access to assembled and packaged drug delivery devices in clinical volumes without the need for significant capital investment in facilities and equipment. By accelerating timelines and streamlining critical steps in the clinical trial process, we aim to support our customers in bringing their drug delivery devices to market efficiently and effectively.
