CN117611039A - Dry powder cell culture medium transportation stability assessment method and transportation device - Google Patents
Dry powder cell culture medium transportation stability assessment method and transportation device Download PDFInfo
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Abstract
The application discloses a dry powder cell culture medium transportation stability assessment method and a transportation device, and relates to the technical field of cell transportation, wherein the stability assessment method comprises two main assessment methods of temperature factors and comprehensive factors, wherein the temperature factor assessment method is divided into an extreme high temperature, extreme low temperature and temperature circulation method, and the comprehensive factor assessment method is an actual worst transportation route method; the method can accurately evaluate the problems possibly occurring in the transportation process of the dry powder culture medium and the influence on the culture medium under various conditions, so that the transportation safety of the culture medium is ensured, and the guiding significance on the production, preservation and transportation conditions is realized.
Description
Technical Field
The invention relates to the field of cell transportation, in particular to a dry powder cell culture medium transportation stability assessment method and a transportation device.
Background
The cell culture medium contains various nutrient elements required by cell growth and metabolism, is an environment system for cell survival, and the stability of the cell culture medium directly determines the state of an engineering cell strain and the yield and quality of an expression product of the engineering cell strain. Therefore, stability studies on cell culture media are required to ensure biopharmaceutical safety and batch stability.
In the actual distribution process of the culture medium products, due to the consideration of factors such as cost, a whole-course cold chain transportation mode is not adopted, so that the temperature deviation, mechanical shock and other harmful risk activities can be inevitably generated in the transportation process, and the product quality and the package integrity of the culture medium are more or less influenced. Cell culture media are raw materials for the production of biologicals. Stability research and investigation are generally carried out by referring to the guiding principle of stability test of raw material medicines and preparations, and mainly comprise a long-term test, an acceleration test and an influence factor test. However, these 3 stability study and investigation methods cannot reflect the actual transportation activity conditions, and the provided guidance value has limitations.
Although the influence of transportation conditions on products is mentioned in both the biological product stability research technical guidelines and the Chinese pharmacopoeia, no specific experimental operation scheme is provided. Therefore, how to simulate the change of the culture medium product in the actual transportation process to the greatest extent through the test, and which evaluation indexes are selected as the standards for the investigation of the stability of the culture medium product, so as to truly reflect the potential risk factors in the transportation environment, and have important significance on the quality influence of the culture medium product.
Chinese patent publication No. CN113567678A discloses a method for evaluating the stability of dry powder of a culture medium, which comprises evaluating the batch-to-batch stability, dry powder storage stability and liquid storage stability of dry powder of the culture medium, but the method does not consider the influence of external condition changes on the dry powder cell culture medium, and the pollution and the safety reduction caused by the reduction of the quality of the culture medium due to environmental changes may occur.
Disclosure of Invention
According to the dry powder cell culture medium transportation stability assessment method and the transportation device, the problem that influences of various conditions and external condition changes on the dry powder culture medium cannot be accurately assessed in the prior art is solved, the temperature changes and comprehensive factors which possibly occur are accurately assessed, the influence on the properties and the use performance of a dry powder cell culture medium product is accurately assessed, and the use safety of downstream production type customers is guaranteed.
The embodiment of the application provides a dry powder cell culture medium transportation stability assessment method, which comprises two main assessment methods including a temperature factor and a comprehensive factor.
Further, the temperature factor evaluation method is classified into an extremely high temperature, extremely low temperature and temperature cycle method.
Further, the comprehensive factor evaluation method is an actual worst transportation route method.
Further, the extremely high temperature is 37+/-2 ℃; the extremely low temperature is-20+/-5 ℃; the temperature cycle is that the temperature is kept for 2 days at the temperature of minus 20 plus or minus 5 ℃ and then kept for 2 days at the temperature of 25 plus or minus 2 ℃ and circulated for 3 times.
Further, the actual worst transportation route is the actual worst transportation route from Shanghai to Chengdu to round trip.
Further, the dry powder culture medium is a Media C culture medium suitable for CHO cells and a Transpro CD 01 culture medium suitable for 293 cells.
Further, the condition that the Media C culture medium can meet the use requirement is within 2d under the high temperature condition, within 7d under the low temperature condition and within 12d under the temperature cycle condition; the condition that the Transpro CD 01 culture medium can meet the use requirement is that the temperature is within 1d under the high temperature condition and within 7d under the low temperature condition, and the temperature circulation condition is not passed due to the turbidity problem; the temperature and shock during transport did not have a significant impact on all physicochemical quality attributes of the two dry powder cell culture media.
A dry powder cell culture medium conveying device comprises an outer shell, a placing box, a first fixing piece and a second fixing piece;
the outer shell is cuboid, the inside of the outer shell is hollow, and the outer wall of the outer shell is made of heat insulation materials;
the shell body is provided with a push plate, a baffle plate, a pull shaft, a convex block and a pull assembly;
the push plate is positioned between the first fixing piece and the outer wall of the outer shell, and a plurality of through holes are formed in the push plate;
the partition board is made of heat insulation material and is positioned between the push plate and the outer wall of the outer shell, and a hole groove for inserting the pull shaft is formed in the middle of the partition board;
the pull shaft is provided with a lug at one end close to the partition board, a pull ring is arranged at one end far away from the partition board, and the pull shaft is in sliding connection with the outer shell;
the convex block is fixedly connected to the push plate;
the traction component comprises a fixed block and a traction groove;
the fixed block is arranged on the push plate, the traction groove is arranged on the convex block of the pull shaft, and the fixed block is in sliding connection with the traction groove;
the placing box is a cuboid box and is used for placing dry powder cell culture medium and is made of toughened glass material, and the placing box is fixedly placed in the outer shell;
the first fixing piece is fixedly arranged in the outer shell and parallel to the placement box, and the first damping piece is arranged in the first fixing piece in a hollow mode; the middle part of the first fixing piece is provided with a fixing mounting piece;
the second fixing piece comprises a second damping piece, a supporting rod and a sleeve;
one end of the second damping piece is arranged on the fixed mounting piece, the other end of the second damping piece is arranged on the placing box, and the second damping piece is sleeved on the outer surface of the supporting rod;
the sleeve is fixedly inserted into the fixed mounting piece, the supporting rod is slidably inserted into the sleeve, and one end, far away from the sleeve, of the supporting rod is fixedly connected with the outer shell;
the convex block is inserted in the channel of the supporting rod and is connected with the supporting rod in a sliding way.
Further, the separator is made of soft rubber material; a heating element is arranged in the space between the partition board and the outer shell; the heating element is fixed on the inner wall of the outer shell.
Furthermore, rosin wax is filled in the space between the partition plate and the outer shell.
One or more technical solutions provided in the embodiments of the present application at least have the following technical effects or advantages:
firstly, by comprehensively considering temperature factors and comprehensive factors, the method comprehensively evaluates the transportation stability of the dry powder cell culture medium, covers various possible transportation conditions and environmental changes, evaluates two specific dry powder cell culture mediums (Media C culture medium suitable for CHO cells and Transpro CD 01 culture medium suitable for 293 cells), enables evaluation results to have more pertinence and practical application value, and can better understand the stability performance of the two culture mediums in the transportation process by setting conditions meeting different requirements.
Secondly, the method adopts specific quantitative indexes to evaluate the transportation stability of the dry powder cell culture medium, such as the change of the standing time and physicochemical quality attribute under different temperature conditions. The quantitative indexes are objective and measurable, so that the stability of the culture medium can be accurately evaluated, and the stability of the culture medium can be evaluated by an actual worst transportation route method, wherein various factors such as temperature, humidity, vibration and the like possibly encountered in the actual transportation process are considered. This makes the evaluation result closer to the actual situation, and improves the practicability of the method.
Thirdly, reducing vibration of pitching impact of the suspension system and vibration generated by inertial force and inertial force generated in back and forth movement by arranging the first damping piece and the second damping piece in different directions; the negative pressure in the outer shell is conveniently released through the push plate, the partition plate and the pull shaft, and the outer shell is conveniently opened and taken out; the space inside the outer shell can reduce the heat transfer when the negative pressure, makes the inside constant temperature that keeps in long-time transportation of outer shell, and ordinary pressure between baffle and the outer shell on the one hand is convenient for take out other space pressure balance when other, on the other hand prevents that the gas leakage of pull shaft department from causing outside gas to get into and reduce heat preservation ability.
Fourthly, rosin wax is a hot bad conductor, has a constant temperature effect, and enables the pressure inside the outer shell to change by melting and solidifying the rosin wax so as to ease negative pressure and take out the culture medium in the placing box.
Drawings
FIG. 1 is a graph showing the change in cell density using the Media C medium of example 1;
FIG. 2 is a graph showing the change in the activity of Media C medium according to example 1;
FIG. 3 is a graph showing the change in cell density using the Transpro CD 01 medium of example 1;
FIG. 4 is a graph showing the change in the activity of the medium of Transpro CD 01 of example 1;
FIG. 5 is a graph showing the change in cell density using the Media c medium of example 2;
FIG. 6 is a graph showing the change in the activity of Media C medium according to example 2;
FIG. 7 is a graph showing the change in cell density using the Transpro CD 01 medium of example 2;
FIG. 8 is a graph showing the change in the activity of the medium using Transpro CD 01 of example 2;
FIG. 9 is a graph showing the change in cell density using the Media C medium of example 3;
FIG. 10 is a graph showing the change in the activity of Media C medium according to example 3;
FIG. 11 is a graph showing the change in cell density using the Transpro CD 01 medium of example 3;
FIG. 12 is a graph showing the change in the activity of the medium using Transpro CD 01 of example 3;
FIG. 13 is a graph showing the change in cell density using the Media C medium of example 4;
FIG. 14 is a graph showing the change in the activity of Media C medium according to example 4;
FIG. 15 is a graph showing the change in cell density using the Transpro CD 01 medium of example 4;
FIG. 16 is a graph showing the change in the activity of the medium using Transpro CD 01 of example 4;
FIG. 17 is a schematic diagram of a dry cell culture medium transporter;
FIG. 18 is an enlarged view of the structure of dry powder cell culture medium transporter A;
FIG. 19 is a schematic view showing a sixth structure of the embodiment;
in the figure: 100. an outer housing; 200. placing a box; 300. a first fixing member; 400. a second fixing member;
110. a push plate; 120. a partition plate; 130. pulling a shaft; 140. a male block; 150. a pulling assembly; 160. a heating member;
141. a slide block;
310. a first shock absorbing member;
410. a second shock absorbing member; 420. a support rod; 430. a sleeve.
Detailed Description
In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings; the preferred embodiments of the present invention are illustrated in the drawings, however, the present invention may be embodied in many different forms and is not limited to the embodiments described herein; rather, these embodiments are provided so that this disclosure will be thorough and complete.
It should be noted that the terms "vertical", "horizontal", "upper", "lower", "left", "right", and the like are used herein for illustrative purposes only and do not represent the only embodiment.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs; the terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention; the term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.
The embodiment of the application provides a dry powder cell culture medium transport stability evaluation method, and dry powder culture medium transport stability test conditions are shown in table 1:
table 1: dry powder culture medium transportation stability test conditions
The dry powder cell culture Media evaluated in this invention are commercial finished Media of our department, which are Media C medium suitable for CHO cells and Transpro CD 01 medium suitable for 293 cells.
The transport stability test conditions of the dry powder cell culture medium are divided into two conditions of temperature factors and comprehensive factors. Wherein the temperature factor comprises two parts of extreme temperature and temperature cycle; and extreme temperatures are classified into extreme high temperature conditions: placing for one week at 37+ -2deg.C and extremely low temperature conditions: -20±5 ℃, for one week, these two extreme temperature conditions being a simulation of the most severe temperature environment that may be encountered during transportation. The temperature cycle conditions are as follows: (-20.+ -. 5) ℃ for 2d and (25.+ -. 2) for 2d, 3 cycles, the temperature cycling conditions are a simulation of the alternating changes in cooling and heating temperatures that may be encountered during transportation.
The comprehensive factor conditions are mainly used for examining the influence of temperature and mechanical shock encountered by the dry powder cell culture medium product in the actual transportation process on the product. The practical worst transportation route from Shanghai to capital is selected for experimental study.
The standard of qualified stability of the dry powder cell culture medium refers to the group standard of serum-free culture medium for cell culture (T/SBIAORG 0002-2022) and the standard of serum-free culture medium for human cell and tissue culture (T/SBIAORG 0003-2022) and is correspondingly adjusted. (1) Appearance: the powder product should have uniform color and no obvious caking. (2) Physical and chemical parameters: the pH change is within + -1.0, osmotic pressure is within + -10%, and turbidity is not higher than 4NTU. (3) Medium efficacy: the maximum viable cell density for cell growth should not exceed + -20% of the fluctuation range of cell viability.
Efficacy evaluation of the dry cell culture medium, batch culture (Batch) test was used. Firstly, preparing a dry powder cell culture medium into a liquid culture medium according to a product use instruction, filtering and sterilizing, and temporarily storing at 2-8 ℃ in a dark place. And centrifuging the seed cells used for testing, removing the original culture medium, and inoculating the seed cells into the prepared liquid culture medium according to the specific cell density for batch culture. The test protocols are shown in tables 2 and 3:
table 2: media C Medium CHOK1 cell batch culture protocol
| Culture medium | Transpro CD 01 |
| Testing cells | 293F |
| Density of inoculation | 5×10 6 cells/mL |
| Rotation speed of shaking table | 110rpm |
| Temperature of cradle | 36.5℃ |
| Concentration of CO2 in shaking table | 8％ |
| Sampling time | Viable cell density and cell viability were recorded on days 0, 3, 5, 7. |
| Sugar supplement strategy | Sugar was measured on days 3 and 5 and supplemented to 8g/L. |
| Culture period | Harvested at 7 days of culture. |
Table 3: transpro CD 01 medium 293F cell batch culture scheme
Example 1
The change of physical and chemical parameters of the dry powder culture medium under the extremely high temperature condition is evaluated according to the evaluation method, and the result is shown in Table 4:
table 4: as can be seen from Table 4, the physical and chemical parameters of the dry powder culture medium are greatly affected by the high temperature (37+ -2deg.C). Specifically, the appearance of the Media C medium changed on day 3, the color of the powder darkened and caking occurred, but the pH, osmotic pressure and turbidity did not change significantly. The appearance of the Transpro CD 01 medium was changed on day 2, and its turbidity increased gradually over time, but pH and osmotic pressure did not change. In addition, as can be seen from fig. 1 to 4, the living cell density of both culture mediums is obviously reduced along with the extension of the high-temperature test time, and especially the growth of cells is inhibited and apoptosis occurs when the high-temperature day 3 of the Transpro CD 01 culture medium starts.
Due to the large number of components in the medium, many components are for example: lipid and vitamin materials are unstable at high temperatures and are usually stored at low temperatures. Therefore, when a stability test is carried out under high temperature (37+/-2 ℃), part of the temperature sensitive components react, so that the appearance change, the solubility reduction and the cell growth of the product are influenced.
The results of physicochemical test and batch culture show that under the high temperature condition (37+/-2 ℃), the Media C culture medium is less than or equal to 2 days, and the Transpro CD 01 culture medium is less than or equal to 1 day, so that the product can meet the use requirement.
Example two
The change of physical and chemical parameters of the dry powder culture medium under the extremely low temperature condition is evaluated according to the evaluation method, and the result is shown in Table 5:
| medium name | Media C Medium | Transpro CD 01 medium |
| Appearance (OD) | White to light pink solid powder | Off-white to light pink solid powder |
| Appearance (7D) | The powder was unchanged in color and slightly agglomerated | The powder was unchanged in color and slightly agglomerated |
| pH(OD) | 7.13 | 7.18 |
| pH(7D) | 7.16 | 7.25 |
| Osmotic pressure/mosm/kg (0D) | 291 | 290 |
| Osmotic pressure/mosm/kg (7D) | 300 | 296 |
| turbidity/NTU (0D) | 1.10 | 1.42 |
| turbidity/NTU (7D) | 2.36 | 3.75 |
Table 5: physicochemical parameter variation of dry powder culture medium under extreme low temperature condition
As can be seen from Table 5, the extremely low temperature (-20+ -5) deg.C conditions did not have a significant effect on both pH and osmotic pressure of the two media; and the color of the culture medium powder is not changed obviously, and only slight caking phenomenon occurs. Although the turbidity of the Transpro CD 01 culture medium after liquid preparation is obviously increased under the extremely low temperature condition, the turbidity does not exceed the quality control range of 4NTU. In addition, as can be seen from the use efficacy figures 5-8 of the two culture mediums, the use performance of the product is not obviously affected by the low-temperature condition, and the use requirement is met.
The results of physicochemical test and batch culture show that under the low temperature condition (-20+/-5 ℃), the Media C culture medium is less than or equal to 7 days, and the Transpro CD 01 culture medium is less than or equal to 7 days, so that the product can meet the use requirement.
Example III
The physical and chemical parameter changes of the dry powder culture medium under the temperature circulation condition are evaluated according to the evaluation method, and the results are shown in Table 6:
| medium name | Media C Medium | Transpro CD 01 medium |
| Appearance (0D) | White to light pink solid powder | Off-white to light pink solid powder |
| Appearance (12D) | The powder was unchanged in color and slightly agglomerated | The powder was unchanged in color and slightly agglomerated |
| pH(OD) | 7.13 | 7.18 |
| pH(12D) | 7.14 | 7.27 |
| Osmotic pressure/mosm/kg (0D) | 291 | 290 |
| Osmotic pressure/mosm/kg (12D) | 308 | 295 |
| turbidity/NTU (0D) | 1.10 | 1.42 |
| turbidity/NTU (12D) | 2.68 | 6.31 |
Table 6: physical and chemical parameter variation of dry powder culture medium temperature circulation condition
As can be seen from Table 6, the temperature cycling conditions [ (-20.+ -. 5) DEG C for 2d and (25.+ -. 2) DEG C for 2d, 3 cycles ] likewise did not have a significant effect on both pH and osmotic pressure of the two media. The color of the two media powders was also unchanged and only slightly agglomerated. However, the turbidity of the Transpro CD 01 medium after the preparation of the liquid under the condition of temperature circulation is obviously increased and does not meet the quality standard (> 4 NTU). In addition, as can be seen from the figures 9-12 of the using efficacy of the two culture mediums, the low temperature condition does not have significant influence on the using performance of the product, and the using requirement is met.
As can be seen from the results of physical and chemical tests and batch culture, the product can meet the use requirement after 12 days of circulation of the Media C culture medium under the temperature circulation conditions of (-20+/-5) DEG C for 2d and (25+/-2) DEG C for 2d and 3 times, and the Transpro CD 01 culture medium cannot meet the use requirement due to the turbidity problem.
Example IV
The physical and chemical parameters of the dry powder culture medium under the condition of comprehensive factors are evaluated according to the evaluation method, and the results are shown in Table 7:
table 7: physical and chemical parameter variation of dry powder culture medium comprehensive factors
The influence of the comprehensive factors (temperature and mechanical shock) on the quality attribute of the culture medium product is examined by adopting an actual worst transportation route. The packaging and transportation of the culture medium are the same as the delivery mode of finished products of my department, and the specific details are as follows: and (3) before transportation, filling the dry powder culture medium into a foam packaging box, placing an ice bag into the box, filling a foam pad for buffering, finally placing the box into a paper box, sealing and packaging.
In the transportation process of the dry powder cell culture medium product, the outer package is not damaged. And as can be seen from table 7 and fig. 13-16, the temperature and vibration in the transportation process have no significant influence on all physical and chemical quality attributes of the product.
Example five
A dry powder cell culture medium transportation device, which comprises an outer shell 100, a placement box 200, a first fixing piece 300 and a second fixing piece 400;
the outer shell 100 is cuboid, hollow inside and made of heat insulation materials;
the outer shell 100 is provided with a push plate 110, a baffle 120, a pull shaft 130, a convex block 140 and a pulling assembly 150;
the push plate 110 is positioned between the first fixing piece 300 and the outer wall of the outer shell 100, and is provided with a plurality of through holes;
the partition board 120 is made of heat insulating material, is positioned between the push plate 110 and the outer wall of the outer shell 100, and is provided with a hole slot in the middle for inserting the pull shaft 130;
the end of the pull shaft 130, which is close to the partition board 120, is provided with a bump, and the end of the partition board 120, which is far away from the partition board, is provided with a pull ring, and the pull shaft 130 is in sliding connection with the outer shell 100;
the convex block 140 is fixedly connected to the push plate 110;
the pulling assembly 150 includes a fixed block 151 and a pulling groove 152;
the fixed block 151 is mounted on the push plate 110, the traction groove 152 is mounted on a projection of the pull shaft 130, and the fixed block 151 is in sliding connection with the traction groove 152;
the placing box 200 is a cuboid box, the placing box 200 is used for placing dry powder cell culture medium, and the placing box 200 is fixedly placed in the outer shell 100;
the first fixing member 300 is fixedly installed in the outer case 100 in parallel with the placement case 200, and the first fixing member 300 is hollow inside and is installed with the first shock absorbing member 310; the first fixing member 300 is mounted at a middle portion thereof with a fixing mount 320;
the second fixing member 400 includes a second shock absorbing member 410, a support bar 420, and a sleeve 430;
one end of the second shock absorbing member 410 is mounted on the fixed mounting member 320, and the other end is mounted on the placement box 200, and the second shock absorbing member 410 is sleeved on the outer surface of the support bar 420;
the sleeve 430 is fixedly inserted into the fixed mounting piece 320, the supporting rod 420 is slidably inserted into the sleeve 430, and one end of the supporting rod 420, which is far away from the sleeve 430, is fixedly connected with the outer shell 100;
the male block 140 is inserted into the channel of the support pole 420 and slidably coupled thereto.
Before transportation, the placing box 200 is placed in the outer shell 100, the interior of the outer shell 100 is pumped into negative pressure to reduce heat diffusion, the partition board 120 and the outer shell 100 are subjected to normal pressure, when transportation is completed, the pull shaft 130 is pulled, the air pressure in the outer shell 100 is firstly balanced with the air pressure between the partition board 120 and the outer shell 100, the resistance of the pull shaft 130 is reduced, and the pull shaft 130 is further pulled to balance the outer shell 100 with the ambient pressure, so that the placing box 200 can be taken out.
The technical scheme has the following effects:
the vibration of the pitch impact of the suspension system and the vibration generated by the inertial force and the inertial force generated in the back-and-forth motion are reduced by arranging the first shock absorbing member 310 and the second shock absorbing member 410 in different directions; the push plate 110, the partition plate 120 and the pull shaft 130 facilitate releasing the negative pressure in the outer shell 100, and opening and taking out; the space between the push plate 110, the partition plate 120 and the outer shell 100 can reduce heat transfer during negative pressure, so that the inside of the outer shell 100 can maintain constant temperature during long-time transportation, and the space between the partition plate 120 and the outer shell 100 is normal pressure, so that the space is balanced with other space pressure during taking out conveniently, and external air is prevented from entering due to air leakage at the pull shaft 130 to reduce heat preservation capacity.
Example six
In the fifth embodiment, vacuum heat preservation is adopted to further enhance negative pressure balance, and the negative pressure balance is further improved by being conveniently taken out after transportation.
The separator 120 is a soft rubber material; a heating member 160 is installed in a space between the partition 120 and the outer case 100; the heating element is fixed on the inner wall of the outer housing 100; the space between the partition 120 and the outer case 100 is also filled with rosin wax.
When the transportation is completed, the heating member 160 increases the temperature of the rosin wax to 15 ℃, the rosin wax melts, and the separator 120 bends toward the push plate 110 due to the negative pressure, so that the negative pressure in the outer casing 100 is relieved, the pull shaft 130 is more easily pulled out, and the transported culture medium can be easily taken out.
Rosin wax, a hot, poor conductor, itself has a constant temperature effect, and by melting and solidifying it, causes the pressure inside the outer housing 100 to change, so as to relieve the negative pressure, and take out the culture medium in the placement tank 200.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The dry powder cell culture medium transportation stability assessment method is characterized by comprising two main assessment methods, namely a temperature factor and a comprehensive factor.
2. The method of claim 1, wherein the temperature factor assessment method is classified into an extreme high temperature, an extreme low temperature and a temperature cycling method.
3. The method of claim 1, wherein the integrated factor assessment method is a practical worst transport route method.
4. The method of claim 2, wherein the extreme high temperature is 3 ± 2 ℃; the extremely low temperature is-20+/-5 ℃; the temperature cycle is that the temperature is kept for 2 days at the temperature of minus 20 plus or minus 5 ℃ and then kept for 2 days at the temperature of 25 plus or minus 2 ℃ and circulated for 3 times.
5. A method of evaluating the transport stability of dry powder cell culture media according to claim 3, wherein the actual worst transport route is the actual worst transport route from Shanghai to Chengdu.
6. The method for evaluating transport stability of dry powder cell culture medium according to claim 1, wherein the dry powder culture medium is Media C medium suitable for CHO cells and Transpro CD 01 medium suitable for 293 cells.
7. The method for evaluating the transport stability of a dry powder cell culture medium according to claim 1, wherein the condition of the Media C culture medium meeting the use requirement is within 2d under high temperature conditions, within 7d under low temperature conditions, and within 12d under temperature cycling conditions; the condition that the Transpro CD 01 culture medium can meet the use requirement is that the temperature is within 1d under the high temperature condition and within 7d under the low temperature condition, and the temperature circulation condition is not passed due to the turbidity problem; the temperature and shock during transport did not have a significant impact on all physicochemical quality attributes of the two dry powder cell culture media.
8. A dry powder cell culture medium conveying device, which is characterized by comprising an outer shell (100), a placement box (200), a first fixing piece (300) and a second fixing piece (400);
the outer shell (100) is cuboid, hollow in the inside and made of heat insulation materials;
the shell body (100) is provided with a push plate (110), a partition plate (120), a pull shaft (130), a convex block (140) and a traction assembly (150);
the push plate (110) is positioned between the first fixing piece (300) and the outer wall of the outer shell (100), and a plurality of through holes are formed in the push plate;
the partition board (120) is made of heat insulation material, is positioned between the push plate (110) and the outer wall of the outer shell (100), and is provided with a hole slot for inserting the pull shaft (130) in the middle;
one end of the pull shaft (130) close to the partition board (120) is provided with a bump, one end far away from the partition board (120) is provided with a pull ring, and the pull shaft (130) is in sliding connection with the outer shell (100);
the convex block (140) is fixedly connected to the push plate (110);
the traction component (150) comprises a fixed block (151) and a traction groove (152);
the fixed block (151) is arranged on the push plate (110), the traction groove (152) is arranged on a convex block of the pull shaft (130), and the fixed block (151) is in sliding connection with the traction groove (152);
the placing box (200) is a cuboid box, the placing box (200) is used for placing dry powder cell culture medium, and the placing box (200) is fixedly placed in the outer shell (100);
the first fixing piece (300) is fixedly arranged in the outer shell (100) and is parallel to the placement box (200), the first fixing piece (300) is hollow, the first shock absorbing piece (310) is arranged in the first fixing piece (300), and the fixing and mounting piece (320) is arranged at the middle part of the first fixing piece (300);
the second fixing piece (400) comprises a second shock absorbing piece (410), a supporting rod (420) and a sleeve (430)
One end of the second shock absorbing member (410) is arranged on the fixed mounting member (320), the other end of the second shock absorbing member is arranged on the placement box (200), and the second shock absorbing member (410) is sleeved on the outer surface of the supporting rod (420);
the sleeve (430) is fixedly inserted into the fixed mounting piece (320), the supporting rod (420) is slidably inserted into the sleeve (430), and one end, far away from the sleeve (430), of the supporting rod (420) is fixedly connected with the outer shell (100);
the convex block (140) is inserted in the channel of the supporting rod (420) and is connected with the supporting rod in a sliding way.
9. A dry powder cell culture medium transporter according to claim 8, wherein the separator (120) is a soft rubber material; a heating element (160) is installed in the space between the partition plate (120) and the outer casing (100), and the heating element is fixed on the inner wall of the outer casing (100).
10. A dry powder cell culture medium transport apparatus as claimed in claim 9, wherein the space between the partition (120) and the outer housing (100) is further filled with rosin wax.
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| CN202311713969.9A CN117611039A (en) | 2023-12-13 | 2023-12-13 | Dry powder cell culture medium transportation stability assessment method and transportation device |
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| CN105713952A (en) * | 2014-12-05 | 2016-06-29 | 中国石油化工股份有限公司 | Biotoxicity assessment method of oilfield chemicals |
| CN110498112A (en) * | 2019-08-20 | 2019-11-26 | 中国人民解放军陆军军医大学第一附属医院 | A kind of cell transporting equipment |
| CN113567678A (en) * | 2020-04-28 | 2021-10-29 | 信达生物制药(苏州)有限公司 | Method for evaluating stability of culture medium dry powder |
| CN115409449A (en) * | 2022-09-01 | 2022-11-29 | 成都拉维美家乐装饰材料有限公司 | Civil engineering building material transportation logistics intelligent monitoring management platform |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105713952A (en) * | 2014-12-05 | 2016-06-29 | 中国石油化工股份有限公司 | Biotoxicity assessment method of oilfield chemicals |
| CN110498112A (en) * | 2019-08-20 | 2019-11-26 | 中国人民解放军陆军军医大学第一附属医院 | A kind of cell transporting equipment |
| CN113567678A (en) * | 2020-04-28 | 2021-10-29 | 信达生物制药(苏州)有限公司 | Method for evaluating stability of culture medium dry powder |
| CN115409449A (en) * | 2022-09-01 | 2022-11-29 | 成都拉维美家乐装饰材料有限公司 | Civil engineering building material transportation logistics intelligent monitoring management platform |
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