Applied Biologics Australia
Applied Biologics Australia

Applied Biologics Australia

Applied Biologics AustraliaApplied Biologics AustraliaApplied Biologics Australia

Building Australia's next generation biologics capability.

About Us

Our Story

Applied Biologics Australia is an independent Sydney‑based biologics and medical device development organisation focused on delivering high‑quality, clinically aligned solutions for the Australian healthcare system.

Our Team

Our team brings together expertise in regulated manufacturing, biomedical engineering, product development, operations, sales and translational research. We operate within a framework built on compliance, safety, and technical excellence — enabling us to support clinicians, hospitals, and industry partners with reliable, standards‑driven outcomes.

Our Mission

To pioneer the development of advanced biologics. As a medical technology manufacturer, we are dedicated to providing the highest quality products and services, ensuring the best outcomes for surgeons and their patients.

Our Capabilities

TGA GMP Licensed Manufacturing

TGA GMP Licensed Manufacturing

TGA GMP Licensed Manufacturing

Applied Biologics Australia is establishing a TGA‑licensed GMP facility. Capabilities include:

  • Controlled, compliant processing environments
  • Validated manufacturing workflows
  • Quality‑assured release systems
  • Full alignment with TGA, NHMRC, and institutional ethics and governance requirements

ISO 13485 Design & Development

TGA GMP Licensed Manufacturing

TGA GMP Licensed Manufacturing

Our engineering and development team operates under an ISO 13485 quality management system, enabling:

  • Medical device design, prototyping, and verification
  • Risk‑managed development pathways
  • Technical documentation and regulatory file preparation
  • Integration of biological materials into device‑based platforms and medical device kits

Partnership Program

TGA GMP Licensed Manufacturing

Partnership Program

We collaborate with clinicians, researchers, startups, and industry groups to accelerate new ideas at the intersection of medical devices and biologicals. Our partnership program provides:

  • Access to GMP‑ready development infrastructure
  • Engineering and regulatory guidance
  • Joint development pathways for novel products
  • Support for validation studies, ethics submissions, grants and translational planning

Contact Us

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