1. Brief Product Description
Growth Bio’s Cell Fiber Disk is an innovative three-dimensional microcarrier specifically designed for high-density culture of anchorage-dependent cells (e.g., mammalian and insect cells). Manufactured from high-quality polyester fiber material compliant with FDA food-contact regulations (21 CFR 177.1630) and certified to USP Class VI standards, the product is fabricated using a proprietary process. Its unique multilayer sheet structure (3–5 layers) provides an exceptionally high specific surface area of up to 1,200 cm²/g, effectively supporting cell attachment and proliferation. The carrier exhibits excellent physicochemical stability, is non-cytotoxic, contains extremely low endotoxin levels, and withstands standard high-temperature sterilization and alkaline cleaning procedures. It is compatible with packed-bed bioreactors, single-use bioreactors, and other culture systems, making it an ideal choice for the production of secreted proteins, viral vaccines, and other biologics.
2. Detailed Product DescriptionIn modern biopharmaceutical manufacturing and life science research, efficient, safe, and reliable cell culture technology is key to success. The Cell Fiber Disk developed by Shanghai Growth Biotechnology Co., Ltd. is an advanced cell culture tool engineered precisely to meet this core need. It is far more than a simple growth substrate—it represents an integrated solution combining principles from materials science, engineering, and cell biology, offering researchers and industrial producers unprecedented culture efficiency and operational convenience.
Exceptional Material Safety and Regulatory Compliance
The foundation of the product lies in the safety of its raw materials. The Cell Fiber Disk is made from polyester (Polyester) and copolyester resin, both of which comply with the U.S. Food and Drug Administration’s (FDA) stringent requirements for food-contact materials (21 CFR 177.1630). More importantly, the material has passed USP Class VI biocompatibility certification—one of the highest safety benchmarks in the medical device and biomaterials industry. According to our comprehensive Material Safety Data Sheet (MSDS), the product is classified as non-hazardous (HMIS health hazard rating: 0), posing no significant toxicity risk via skin contact, eye exposure, inhalation, or ingestion. Its acute oral LD₅₀ exceeds 40,000 mg/kg, demonstrating exceptional biological safety. Furthermore, quality reports confirm zero cytotoxicity, fully complying with the Chinese standard GB/T 16886.5-2003, ensuring healthy, undisturbed cell growth on its surface.
Innovative Multilayer Sheet Structure Design
Unlike conventional spherical microcarriers or flat culture dishes, the Growth Cell Fiber Disk features a revolutionary multilayer sheet design. Each disk consists of 3 to 5 precisely stacked layers of polyester fiber, with each layer only 0.44 mm thick and a pore size of approximately 15 micrometers. This sophisticated architecture offers multiple advantages:
1.Extremely High Specific Surface Area: Each gram of carrier provides up to 1,200 cm² of effective cell-adherent surface area, dramatically increasing cell density per unit volume and significantly boosting yields of target products (e.g., therapeutic proteins, viral vectors).
2.Gentle Culture Environment: Cells grow within the internal multilayer structure, naturally shielded from external shear forces generated by agitation and physical stress from bubble bursting during sparging. This creates a near-static microenvironment similar to roller bottle culture, greatly reducing mechanical damage—especially beneficial for shear-sensitive, fragile cell lines.
3.Efficient Mass Transfer: Despite its layered construction, the open-pore network ensures culture medium flows freely throughout the entire carrier, enabling efficient exchange of nutrients, oxygen, and metabolic waste—maintaining the viability and functionality of even deep-layer cells.
Broad Application Compatibility and User-Friendly Workflow
The Growth Cell Fiber Disk demonstrates outstanding versatility and has been validated for use with a wide range of critical anchorage-dependent cell lines, including but not limited to Vero, CHO, BHK, MDCK, HEK293, SF9, and various primary cells. Whether used in basic research, vaccine production, or recombinant protein manufacturing, it performs excellently across multiple platforms, including packed-bed bioreactors, single-use stirred bioreactors (e.g., spinner flasks), and static culture vessels.
To simplify user operations, we recommend a standardized workflow:
First, soak the carrier in purified water to ensure full hydration.
Then rinse with PBS buffer to remove potential impurities.
After loading into the bioreactor, perform steam sterilization directly (recommended condition: 135°C for 1 hour).
Our quality control data confirm the carrier remains stable under these conditions, with minimal organic leachables. Once sterilized and cooled, the system can be filled with culture medium for sterility testing. Upon confirmation of sterility, cells can be seeded (recommended density: 100,000–200,000 cells/mL) to initiate routine culture.
At the end of cultivation, harvesting is remarkably simple: simply remove the entire carrier to easily collect the target product from the supernatant, or proceed with further processing of the adherent cells.
Rigorous Quality Control System
As a manufacturer adhering to current Good Manufacturing Practice (cGMP) standards, Shanghai Growth Biotechnology implements the strictest quality controls at every stage of production. Every batch undergoes comprehensive testing to ensure key parameters meet or exceed specifications. For example:
Endotoxin levels are tightly controlled to < 0.25 EU/mL (surpassing the stated specification of 0.50 EU/mL),
Bioburden is < 2 CFU/g,
The carrier stably withstands immersion in 0.5N cold alkali solution for 24 hours—enabling deep cleaning or reuse in GMP environments.
All these efforts are dedicated to providing customers with a cell culture platform that delivers consistent performance, reliable results, and complete trustworthiness.
3. Product Specifications
| Parameter Category |
Specific Parameter |
Specification / Value |
| Basic Physical Properties |
Material |
Polyester fiber |
|
Physical Form |
Multilayer sheet |
|
Single Layer Thickness |
0.44 mm |
|
Pore Size |
～15 μm |
|
Specific Surface Area |
1,200 cm²/g |
|
Dimensions |
8 mm × 9.6 mm |
|
Number of Layers |
3–5 layers |
| Biological Safety |
Cytotoxicity |
None (Grade 0) |
|
Endotoxin |
< 0.25 EU/mL |
|
Bioburden |
< 2 CFU/g |
|
USP Certification |
USP Class VI |
| Physicochemical Stability |
High-Temperature Sterilization |
≤ 135°C |
|
Cold Alkali Resistance |
Resistant |
|
Melting Point |
> 165°C |
| Application Information |
Compatible Cell Types |
VERO, CHO, BHK, MDCK, ST, MARC-145, MRC-5, SF9, HEK293, 123A, 127A, GAMMA, primary cells, etc. |
|
Primary Applications |
Secreted proteins, virus production |
|
Compatible Equipment |
Packed-bed bioreactors, single-use bioreactors, culture vessels, spinner flasks |
| Packaging & Storage |
Packaging Options |
500 g/bag, 1,000 g/bag |
|
Storage Conditions |
Store in a dry, cool place; avoid heat, sparks, and open flame |
| Regulatory Information |
Manufacturing Standard |
cGMP |
|
Transport Regulations |
Non-hazardous; not subject to transport restrictions |
