Ensera and Argonaut Partner to Streamline Supply for Drug-Device Combination Products

Delivering an integrated fill-finish and device assembly and packing collaboration to reduce complexity and accelerate time to market for combination products.

CARLSBAD, Calif.--(BUSINESS WIRE)--Today, Argonaut Manufacturing Services (“Argonaut”), a US-based sterile fill-finish CDMO, and Ensera, a CDMO with facilities in the US, and Europe and Asia, specializing in final assembly and secondary packaging for drug delivery systems, announce a new strategic partnership.

The collaboration aligns aseptic fill-finish with device assembly and packaging services to simplify supply chains, reduce operational risk and accelerate production timelines.

Argonaut provides aseptic fill-finish of vials, syringes, and cartridges using Annex 1 compliant isolator filling lines, as well as analytical testing and stability studies. Ensera complements these capabilities with final assembly of drug delivery devices, labelling, secondary packaging, kitting, serialization, sterilization management and testing for vials and drug delivery devices.

Through the partnership, customers can benefit from a streamlined quotation process covering both organizations’ services before starting a project. Projects that contract Argonaut and Ensera will benefit from closely coordinated project management that supports aligned fill-finish and device assembly activities across all stages of development and manufacturing.

Argonaut has completed an audit of Ensera’s U.S. facility and approved Ensera as a critical supply chain partner. This demonstrates the companies’ commitment to aligning high quality standards for clinical and commercial programs.

By leveraging expertise within and improving coordination between manufacturing stages, the partnership addresses several growing challenges in the combination product landscape, supply chain fragmentation, constrained capacity for mid-market programs, and increasing pressure to accelerate timelines for specialty biologics and biosimilars.

Rick Hancock, CEO, Argonaut, commented:

“More than ever, our clients are focused on developing their products in conjunction with autoinjectors to improve accessibility for patients. While this is a commendable goal, it adds complexity to supply chains. This partnership with Ensera eases that burden for sponsors. Just as our clients are focused on improving the patient experience, Argonaut is focused on improving our clients' experience.”

Jason Anderson, CEO, Ensera, added:

“This partnership reflects a shared focus on supporting the needs of pharmaceutical companies developing complex combination products, particularly in low to mid-volume scenarios where flexibility and coordination are essential. By aligning our device assembly and packaging expertise with Argonaut’s fill-finish capabilities, we are making it easier for customers to navigate critical transition points, reduce risk, and maintain momentum as their products progress toward commercialization.”

Both companies will be attending the BIO International Convention in San Diego, where they will be available to discuss how the collaboration can support upcoming programs.

About Argonaut

Located in Carlsbad, CA, Argonaut is a fill-finish CDMO specializing in clinical to commercial aseptic manufacturing of vials, syringes, and cartridges. The company operates two isolator-based, fully automated filling lines compliant with Annex 1 and FDA standards and utilizes high-yield processes and 100% weight checks to significantly reduce line losses. Argonaut also provides onsite analytical support and stability studies.

Learn more at www.argonautms.com

About Ensera

Ensera is a global CDMO supporting pharmaceutical and medical device companies with device design, final assembly, labeling, and secondary packaging of injectable formats, including autoinjectors and pre-filled syringes.

Its flexible GMP cleanroom operations across Europe and the US are optimized for low-to-medium batch volumes, supported by integrated quality systems and cold chain infrastructure. An approved assembly partner for leading autoinjector platforms from SHL, Ypsomed and BD, Ensera combines device and pharmaceutical expertise to deliver efficient, compliant supply for combination products.

Learn more at www.ensera.com