The Animal-Free Blueprint: Building Better Factories for a Trillion-Cell Future

Date : 2025-12-02

Publisher : CytoNiche | Marketing

CytoNiche Biotech, widely recognized as the “3D Cell Architect”, has announced the full integration of its 3D RecomTrix™ Recombinant Collagen Microcarriers CW01 into its established 3D FloTrix™ manufacturing platform. As one of the few global players capable of delivering truly clinical-grade, billion-scale 3D cell manufacturing, CytoNiche continues to bridge industrial throughput with the biological precision required for advanced therapies.

Built on the company’s proven technologies—including 3D TableTrix™ Microcarriers, the 3D FloTrix™ vivaSPIN-SU Single-Use Cell Culture System, and the 3D FloTrix™ vivaPREP ULTRA Cell Processing System—the platform has already supported multiple IND submissions and contributed to the approval of China’s first allogeneic stem cell drug. With the incorporation of CW01, CytoNiche now offers an expanded, chemically defined, and globally aligned solution that meets the evolving demands of clinical-grade, high-capacity cell therapy manufacturing.

Elevated Safety on a Validated Platform

3D RecomTrix™ Recombinant Collagen Microcarriers CW01 is a next-generation, recombinant human collagen–based material that is animal component–free (ACF) and Good Manufacturing Practice(GMP) grade. Designed to meet FDA, EMA, and NMPA expectations for clinical-grade starting materials, it removes xenogeneic contamination risks while maintaining high expansion performance.

Key features:

Highly porous 3D architecture (>90% porosity), enabling improved nutrient exchange and spatial cell colonization, with a large surface area of 8,000 cm²/g.
Elastic, biomimetic structure that recapitulates the native extracellular matrix, designed to withstand shear forces in stirred-tank bioreactors.
Enzyme-free release enabled by cleavable crosslink chemistry, supporting gentle cell harvest with >90% viability.
Gamma-sterilized and instantly dispersible, eliminating pre-conditioning steps and supporting closed, automated workflows.

Importantly, CW01 is fully compatible with existing 3D FloTrix™ Technology, enabling developers to adopt CW01 without modifying established workflows.

Fig 1: 3D FloTrix™ Technology with CW01

10 Billion-Scale Output, Clinical-Grade Quality

With 3D FloTrix™ vivaSPIN-SU Single-Use Cell Culture System, the CW01 supports robust, reproducible expansion of mesenchymal stromal cells (MSCs), consistently delivering:

>10 billion cells per batch, representing a production scale aligned with clinical and commercial needs.
9–13 days total culture duration, starting from cryopreserved stocks
>95% final viability at harvest, reflecting both bioprocess robustness and biomaterial compatibility.

Fig 2: High Yield and Viability of Grown MSCs with CW01

Qualified Cells & Exosomes: High Purity, Low Endotoxin, Clinical-Standard Compliant

The cell and exosome products produced via the CW01 manufacturing platform have undergone a comprehensive set of quality inspections, including assessments of color, clarity, sterility, cell morphology, particle size range, phenotypic identification, as well as mycoplasma and endotoxin testing. All test items comply with relevant standards and meet the requirements for GMP manufacturing and clinical use.

Test	Result	Remarks
Colour	Colourless	QC PASSED ☑
Clarity	Slightly turbid due to cell suspension	QC PASSED ☑
Sterility test (USP 71 method)	No microbial growth	QC PASSED ☑
Cell Morphology	Spindle-shaped	QC PASSED ☑
Immunophenotyping (Surface Marker Testing)	Positive markers (CD90, CD73 and CD105) are within range	QC PASSED ☑
Presence of mycoplasma	Negative	QC PASSED ☑
Endotoxin level	≤ 0.25 EU/mL	QC PASSED ☑

Table 1: Certificate of Analysis of MSCs

Test	Result	Remarks
Colour	Slightly yellow	QC PASSED ☑
Clarity	Clear solution	QC PASSED ☑
Size	Particle size peak within 30 - 150 nm range	QC PASSED ☑
Sterility test (USP 71 method)	No microbial growth	QC PASSED ☑
Surface marker testing (ELISA-based method)	CD9 and CD63 are detected	QC PASSED ☑
Presence of mycoplasma	Negative	QC PASSED ☑
Endotoxin level	≤ 0.25 EU/mL	QC PASSED ☑

Table 2: Certificate of Analysis of Exosomes

Validated at Scale: Powering Global Cell Therapy Innovation

The animal-free component 3D FloTrix™ technology has emerged as a cornerstone of CytoNiche Biotech’s global strategy—unlocking new blue-ocean markets, accelerating entry into international markets and strengthening brand recognition.

In 2024, CytoNiche secured several multi-million-RMB commercial agreements with partners worldwide, marking the first successful integration of this Chinese-developed, xeno-free microcarrier platform into clinical- and commercial-scale cell therapy manufacturing workflows across the world.

A recent large-scale client deployment demonstrated the platform’s performance, generating:

>10 billion viable MSCs in nine days
30 liters of GMP-grade exosomes
400 vials of clinical-grade cell drug substance

These outcomes establish a new operational benchmark that aligns manufacturing efficiency with the stringent requirements of emerging cell and exosome therapies.

Fig 3: Client’s 3D Cell Manufacturing Platform

Two Paths, One Platform

To accommodate diverse regulatory strategies and development timelines, CytoNiche offers two complementary microcarrier solutions:

3D TableTrix™ Microcarriers
Cost-effective and widely validated—ideal for early development and screening.
3D RecomTrix™ CW01
Animal component–free, chemically defined, and optimized for global commercialization.

Both are compatible with the same 3D FloTrix™ manufacturing systems, allowing developers to flexibly choose or combine materials based on product needs, regulatory pathways, and supply chain considerations.

Parameter	Specification
Structure	3D porous spherical microcarrier
Porosity	> 90%
Material	Animal-free recombinant collagen protein
Degradability	Fully degradable
Sterility	Sterile
Particle Size (Dry Powder)	100-200 μm
Pore Size Range (Swollen)	30-50 μm
Effective Surface Area	8000 cm²/g
Suitable Cell Types	Adherent cells (e.g., MSCs)
Usage	Ready-to-use
Cell Harvest Method	Microcarrier degradable process