PLLA Poly-L-Lactic Acid Microspheres | Long-Acting Progressive Collagen Regeneration Substrate
Technical Specifications
Particle Size (D50): 20–50μm
Purity: ≥98%
Endotoxin: ＜0.1 EU/mg
Degradation Period: 12–18 months
Product Introduction
Poly-L-Lactic Acid (PLLA) is an implant-grade high-crystallinity biomedical regenerative raw material, developed for mass production of Class II & Class III medical devices, biomaterial formula R&D, and customization of high-end composite regenerative substrates. Formed into uniform spherical crystalline microspheres, it features stable degradation profile, steady collagen-inducing activity and outstanding mechanical supporting strength. It serves as the core solid microsphere material for long-term soft tissue regeneration medical devices, volumetric repair consumables and composite regenerative gel substrates.
It can be compounded with bioactive proteins including recombinant Type I/III collagen, silk fibroin, as well as hyaluronic acid, to develop dual-effect composite raw material solution of Regenerative Microspheres + Bioactive Proteins, supporting project initiation and mass production of high-end regenerative medical aesthetic device materials.
Mechanism of Action
After implantation into soft tissue, regular spherical crystalline PLLA microspheres undergo mild and controllable hydrolytic degradation with slow and uniform release of lactic acid monomers. The minor fluctuation of local acid-base environment effectively reduces adverse reactions such as nodules and acute inflammation of downstream finished preparations.
The rigid microsphere skeleton continuously stimulates the proliferation and differentiation of fibroblasts to induce orderly three-dimensional regeneration of autologous Type I and Type III collagen. It realizes three core functions: soft tissue volumetric filling, mechanical contour support and dermal tissue remodeling. Aligned with the efficacy logic of long-term implantable medical devices, finished products deliver durable shaping effect with natural and supple regenerated tissue without rigid filler appearance.
Core Product Advantages
High-Crystallinity Uniform Microspheres for Stable Mass Production
Well-organized crystal structure and high sphericity guarantee consistent collagen-inducing activity and mechanical supporting performance among batches, adapting to standardized assembly-line production of downstream medical device manufacturers with low performance fluctuation of finished products.
Customizable Full-Range Physicochemical Parameters
Customizable particle size range, degradation cycle and crystallinity ratio. We support development of multi-gradient raw materials including short-term wound repair, medium-term soft tissue repair and long-term contour shaping, facilitating the R&D and launch of medical devices with different registration classifications and product positioning.
Wide Compatibility for Composite Active System Formulation
Excellent compatibility with hyaluronic acid, recombinant active collagen, silk fibroin and polysaccharide matrix. The blended system features even dispersion without agglomeration or delamination, helping clients rapidly develop composite formulas of Regenerative Microspheres + Bioactive Proteins to shorten formula debugging cycle and cut R&D trial-and-error costs.
Strict Implant-Grade Quality Control to Support Medical Device Registration
Produced via closed polymerization process with medical-grade monomers to strictly control organic impurities and protein residues, achieving qualified endotoxin indicators and high batch-to-batch consistency. Complete technical documents including COA, MSDS and SEM morphology test reports are provided for downstream manufacturers’ medical device testing and domestic & overseas registration application.
Target Customers & Application Scope
Overseas medical device manufacturers, leading domestic medical aesthetic raw material supply chain groups, biomedical research institutes, biomaterial research laboratories
Commercial Application Scenarios
Mass Production Support for Medical Device Manufacturers
Used as core raw material for industrial production of single-component PLLA implantable consumables and PLLA composite regenerative filling devices compounded with active collagen/hyaluronic acid, supporting the manufacturing of Class II & Class III implantable medical aesthetic devices.
In-Depth Compound Cooperation with Large-Scale Raw Material Groups
Supply bulk industrial-grade microsphere raw materials for partners to conduct secondary compounding with bioactive proteins and hydrogel matrix, so as to develop differentiated composite regenerative raw materials for channel distribution.
R&D Cooperation with Scientific Research Institutions
Supply standard samples and customized modified samples for biomaterial research projects, pre-research of innovative regenerative medical devices, animal efficacy verification, pre-registration pharmacology and toxicology tests.
Compliance Disclaimer
Our company focuses on the R&D and bulk sales of biomedical raw materials. We do not supply products to medical aesthetic clinics, beauty salons or individual end consumers, nor do we produce, subpackage or sell finished medical aesthetic devices and skincare products. Customers shall independently complete formula development, preparation processing, domestic & overseas medical device registration certification and other commercial procedures. Finished products can only be launched into market after obtaining full compliance approval. The content on this page only objectively demonstrates the physicochemical properties and application directions of raw materials, and shall not be regarded as efficacy commitment for finished medical devices, clinical operation guidance or commercial efficacy endorsement.