From Nature to Innovation

The Journey of Type I Collagen

At TypeOne Biomaterials, we transform Type I collagen – a protein of extraordinary biological relevance – into high-performance materials for medical and regenerative applications.

Our process integrates advanced biotechnological techniques with stringent quality controls to ensure that every product delivers consistent bioactivity, safety, and clinical efficacy.

Sourcing & Raw Collagen Extraction

The process begins with the careful selection of raw material sources, such as bovine or porcine tendons or other approved tissues, chosen for their high natural content of Type I collagen. These materials are rigorously tested for biocompatibility and traceability to meet stringent regulatory and clinical requirements.

Extraction is performed using proprietary methods that preserve the native triple-helix structure of collagen—a critical factor for its bioactivity. Through controlled enzymatic digestion and purification, we remove non-collagenous proteins, fats, and other impurities while maintaining the molecular integrity of the collagen fibers.

Collagen Purification
and Stabilization

Purified collagen undergoes further refinement to achieve pharmaceutical-grade purity. Advanced filtration, pH stabilization, and sterile processing steps ensure that the collagen retains optimal solubility and biocompatibility while eliminating endotoxins and other potential contaminants.
The stabilized collagen can then be processed in various forms—soluble, reconstituted fibrillar, or lyophilized—according to its intended use in subsequent manufacturing stages.

Production of Semi-Finished
Collagen Materials

Purified collagen is transformed into semi-finished products, including:

Membranes

for wound healing and surgical applications

Medical Devices

Sponges and matrices

for tissue regeneration and 3D scaffolding

Injectable gels

for aesthetic and regenerative medicine

Fibers and coatings

Fibers and coatings

Each format is engineered with precise control over fiber alignment, porosity,
mechanical properties, and degradation kinetics—critical parameters that influence clinical performance.

Finished Product Manufacturing

Semi-finished materials are then integrated into finished medical devices, often in cleanroom ISO 5/ISO 7 environments. Key processes include:

Shaping and molding

of membranes, patches, or implants

Crosslinking

to adjust bioresorption rates when required

Sterilization

(e.g., gamma irradiation or ethylene oxide) validated to preserve collagen’s bioactivity

Packaging and labeling

in compliance with CE and FDA regulations

At every stage, we perform comprehensive quality testing—including molecular integrity assays, biocompatibility testing, and mechanical performance evaluation—to ensure that the final product meets the exacting standards required for use in regenerative medicine and medical aesthetics.

Why It

Type I collagen is not merely a building block—it is a dynamic signaling molecule that drives tissue regeneration. By preserving its structure and bioactivity throughout our proprietary processing chain, we enable the development of advanced biomaterials that promote true biological healing—not just symptom relief.