Manufacturing

Specialized manufacturing for acellular biologic devices

From tissue to finished device.

Acellular biologic matrices are specialized products made by very few manufacturers. Making them safely depends on complex processes and deep expertise in tissue sourcing, purification and quality control. Helios Biomedical has built that expertise over more than 25 years, and we put it to work for companies bringing biologic devices to patients.

We manufacture both commercial and clinical products today, so we understand what each stage of a program needs, from early feasibility to steady commercial supply.

Capabilities

  • Process development and scale-up

    Adapting the EBM process to new device designs and volumes.

  • GMP manufacturing

    Sheet matrices and investigational injectable matrices in controlled cleanroom environments.

  • Packaging and sterilization management
  • Quality control and testing

    In-house QC with release testing on campus.

  • Quality systems and regulatory support

    ISO 13485:2016 certified

Our Natick campus

Manufacturing, quality control and R&D share one campus. Keeping these functions together shortens hand-offs, simplifies logistics and keeps our know-how in one place.

Developing an acellular biologic device, or looking for a reliable U.S. manufacturing partner?

Let’s talk.

Discuss Your Project