NEST BioFactory™

Biofactory™

Strict product quality supervision

production environment-- Class 10,000 clean production workshop

Nest cell factory is produced in a dedicated 10,000-class clean room, and other products are produced in a 100,000-class clean room.

production material--Strictly selected polystyrene conforming to USP Class VI standard

Production Process--Strictly follow SOP for production and quality control

Exquisite product design, Highprecision forming, ultrasonic welding, no chemical addition.

Surface treatment--Tissue culture treated

The surface of the cell culture container is treated with hydrophilic treatment to ensure that the cells adhere to the surfacemore evenly, more stable and better adsorption capacity.

Product expiration date verification

The cell growth surface can still meet the cell growth requirements after three years of aging, and there is no positive result of the sterility test.

Biosafety testing

Refer to <>, The product is tested for cytotoxicity, sensitization, intradermal irritation, acute systemic toxicity and hemolysis.

Physical and chemical safety testing
Refer to <>, The products are tested for insoluble particles, ignition residues, metal elements, and dissolved substances (clarity, color, pH, UV absorbance, non-volatile matter, easy oxides, heavy metals).

Process testing

In order to ensure the structure and strength of the product, it is necessary to verify the performance of relevant equipment, such as injection molding machines, molds, plasma equipments, welding machines, leakage meter and so on before production. After production, the product should be verified for sealing, strength, dropping and transportation.

Cell growth test

Cell growth homogeneity experiment.

Cell factory validation test--- Sterility and particle guarantee

Product initial bioburdencontamination test, irradiation dose setting, dose review, aseptic packaging verification, irradiation process verification, product sterility and particle testing.

Applicable cells

VERO.MRC-5.c.293T.L-929

Packaging strength verification

The breakage rate is less than 3% after repeated long distance delivery challenges.

Sterility Guarantee---Importedntroduced Rhodotron® TT200 electron accelerator from Belgian IBA company, Self-built irradiation center.

The irradiation sterilization process has passed ISO 13485 and ISO 11137 quality system certification.

NEST BioFactory system is a well-designed cell culture device that utilizes the maximum culture area in a limited space, saving a large amount of space, low-cost to achieve the purpose of expanding production capacity.

NEST BioFactory system can be used for industrial scale production such as vaccine, monoclonal antibodies or biopharmaceuticals production, and they are suitable for adherent cell culture.

Specifications: Single layer, 2 layers, 5 layers, 10 layers and 40 layers

Nest BioFactory Versus Rolling Bottles

Advantages of BioFactory

1.Large culture area with less space occupied;

2.Reduced manual operations to decrease contamination risk;

3.Can be operated manually or combined with automated equipment for use;

4.Can realize standardized operations to reduce intra-batch difference.

Disadvantages of Rolling Bottles

1.Heavy workload of manual operations;

2.High risk of contamination;

3.A large amount of washing and verification processes;

4.Poor controllability of the production processes with large intra-bottle difference, hard to unify the quality of different batches;

5.Large space occupation, hard to rapidly expend the production scale;

6.Low level of automation.

Comparison of Utilization Rate

Design Characteristics of BioFactory

1.Large-caliber Connection Channel

Large-caliber connection channel may quickly equilbrium the culture medium and shorten the liquid adding progress, to better increase cell viability.

2.One-piece Injection Molding for Mouth and Body

Ensure better sealability and better strength.

3.Strong Packaging

Double-layer air-exhausted packaging: meet the use requirements of pharmaceutical clients.

Built-in protection layer: hard to be damaged, suitable for long-distance transportation.

4.Unique Design of Cap

[Petal" pattern distribution of pores, to enhance gas exchange to facilitate cell culture.

User Manual

Biofactory User Instructions

Cell Culture

Step1, Pour the prepared culture medium into the cell factory (Volume suggestion: 150 - 200 mL for each layer).

Step 2, Lay the cell factory on its side to balance the liquid level.

Step 3, With the liquid-adding opening upward, the culture medium will be evenly distributed to each layer after standing.

Step 4, Slowly place the cell factory in a horizontal position.

Step 5, Incubate in a cell incubator.

Precautions

1.Please pre-heat the cell factory and culture medium to the culture temperature: since it takes a long time for a large incubator to reach the set culture temperature, pre-heating the cell factory and culture medium to the culture temperature before starting the experiment may speed up cell attachment and significantly increase cell recovery.

2.Slow operating is required to avoid occurrence of air bubbles caused by sharp shaking: air bubbles may lead to flowing the medium from an upper layer to a lower layer.

3.Avoid spraying the alcohol onto the breathable cover, since alcohol may wet the hydrophobic membrane filter and make it impermeable and consequently affect the gas exchange or causes pressure imbalance during operations.

Cell Harvest

Step 1, After the culture is completed, pour the culture medium out.

Step 2, Wash the factory with the calcium- and magnesium-free phosphate buffer solution (CMF-PBS) (40-50 ml/layer) and if necessary, repeat the washing process.

Step 3, Digestion: pre-heat the digestion solution (10-40 ml/layer) in advance.

Step 4, Collection: centrifuge for 5 min at 1000 rpm, remove the digestion solution and collect cells.

Step 5, Washing: wash the incubator with CMF-PBS or culture medium after digestion.

Precautions

1.Ensure that the culture surface of each layer is completely immersed in the CMF-PBS, and gently shake the cell factory forward and backward to wash off the residual culture medium.

2.Distribute the digestion solution evenly to each layer; gently tilt the incubator forward and backward, left and right to ensure that the digestion solution has completely covered the culture surface; gently tap the incubator to help the cells detach from the surface.

3.Since it is unable to clearly observe the digestion status of the cells in the middle layers of a cell factory, it is recommended to refer to the digestion status of a culture flask or a single-layer cell factory under exactly the same culture conditions. Or, use a dedicated observation platform for multiple-layer cell incubators to observe the growth status of cells in each layer.

4.If there are numerous cells present in the washing solution or the culture layers of the cell factory, it is necessary to wash for multiple times or adjust the procedure of cell digestion.

5.Even a slight deviation of the culture temperature may affect the cell harvest rate, so it is required to pay close attention as to whether or not the culture temperature is exactly the set temperature.

BioFactory Accessories

FAQ

How to use a microscope to observe the cell growth in a BioFactory?

1.Use an inverted microscope to observe directly, however, it`s only suitable for observing a BioFactory with 1-10 layers. The growth status in the bottom layers 1 and 2 can be observed, but only for the cell growth uniformity. It is not suitable for a 40-layer BioFactory . Please contact the microscope manufacturer for more details.

2.Observe with a microscope dedicated for BioFactory observation, which has a lens in two directions for side observation and bottom observation, respectively; the cell size and growth density can be calculated using a size measurement system by observing cell status with a microscope. This model of microscope is suitable for BioFactory with any number of layers.

3.Since the cell growth conditions (surface-capability relationship) of NEST BioFactory are the same as those of NEST Cell Culture Flasks, the cell culture flask can be used simultaneously to replace BioFactory for observation, or use a 1-layer BioFactory for reference.

How many cells may be inoculated in each type of BioFactory?

NEST BioFactory are made of the same raw materials using same production processes as those of NEST cell culture flasks and the cell surface and growth status are basically the same as that of cell culture flasks. Since each kind of cells have different growth characteristics and different requirements for surface density and environment, for the number of cells that can be inoculated in each type of BioFactory, it cannot be simply generalized. Users are recommended to determine the number by multiplying the inoculation density per unit area in the cell culture flask with the used culture area of BioFactory.

Volumes of various working solutions used in the cell culture.

The BioFactory allows large-scare cell culture in a compact space using its multiple-layer stacked structure. How much culture medium should be added in during use? And how much trypsin solution should be added in for cell digestion?

The BioFactory are divided into large-caliber ones and small-caliber ones, what are their respective characteristics?

1.After years of research and development, the NEST BioFactory now have a complete product selection and clients may freely choose from BioFactory with of two wide caps, with two narrow caps or with one wide cap and one narrow cap according to their operating and use needs.

2.Characteristics of two wide caps: suitable for manual operations of adding and removing liquid, can also be connected with tubing; generally used during the phase of laboratory research.

3.Characteristics two narrow caps: suitable for being connected with tubing to facilitate subsequent process scale-up; generally used for scale production. Characteristics of one wide cap and one narrow cap: suitable for tubing connection and manual operations; used for scale production and laboratory research. Breathable cap: the inner is covered with a 0.22um hydrophobic film, which is air penetrable and can block bacteria and water, as well as avoid gas bloating caused by adding liquid.

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