CN208917203U - The production unit in improved biological products workshop - Google Patents
The production unit in improved biological products workshop Download PDFInfo
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- CN208917203U CN208917203U CN201821076809.2U CN201821076809U CN208917203U CN 208917203 U CN208917203 U CN 208917203U CN 201821076809 U CN201821076809 U CN 201821076809U CN 208917203 U CN208917203 U CN 208917203U
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Abstract
The utility model relates to a kind of production units in improved biological products workshop, the utility model is independently equipped with dedicated culture medium preparing tank to each reactor by preparing module in culture medium, and it is equipped with multiple on-line cleaning systems, the cleaning of reactor and culture medium preparing tank is carried out simultaneously, to allow to improve production efficiency under the premise of reducing reactor cost by scientific and reasonable operating scheme, and effectively reduce pollution risk.
Description
Technical field
The utility model relates to a kind of production units in biological products workshop, more particularly, to biological products workshop, production
Assembly line layout.
Background technique
As more and more people are indebted to biological products, the competition of field of biological product is also more fierce, and biological
Product workshop is not only related to biologics production scale, production efficiency and the production cost of biopharmaceutical company, is also relate to
Strain the ability in market.Therefore, the production line layout and production method in the bio-pharmaceuticals workshop of rationalization, will effectively help
Biopharmaceutical company is helped to improve product competitiveness.
The production of biological products mainly includes two stages of Cell isolated and cultured, i.e., whole stage reactor line (with
Lower abbreviation reactor line) in complete cell culture, then complete to isolate and purify in isolating and purifying production line, production capacity mainly by
Whole stage reactor is determined with equipment is isolated and purified.A plurality of reactor line can be used in actual production and one isolates and purifies line
Above-mentioned production process is completed, wherein during a plurality of reactor line is set between same culture, and equipped with a set of common culture medium
Compounding system and a set of on-line cleaning system (CIP), each reactor line are spending certain cultivation cycle one batch of completion
Cell culture after, it is necessary to spend certain preparatory period of clearing out a gathering place successively to clear out a gathering place to reactor line and culture medium preparing tank again
Prepare (including CIP step), the cell culture of next batch can be carried out again.Therefore switched in reality using multiple reactor lines
Production, so that the time before each reactor line arrives after completing certain batch cultivation to next batch is cleared out a gathering place and is prepared,
The efficient switching effect between batch can be played, influence of the preparatory period to production capacity of clearing out a gathering place is reduced.
In cell culture, the cultivation cycle of whole stage reactor is usually 14 days or so, clearing out a gathering place between batch and preparatory period
Usually 6 days or so, the sum of every period was 20 days or so.Purification cycle in isolating and purifying is usually 7 days or so.
The characteristics of being directed to the above-mentioned period in the prior art, is often used 3 reactor lines and is most efficiently cut between batch with playing
The effect changed, interval time are 7 days.Such as reactor line 1-3 is usually run in the following way:
(1) reactor 1 starts to cultivate the cell of first batch；
(2) after a specific batch interval time (such as 7 days), reactor 2 starts to cultivate the cell of second lot；
(3) after two specific batch interval times (such as 14 days), reactor 3 starts to cultivate the thin of third batch
Born of the same parents；
(4) after three specific batch interval times (such as 21 days), reactor 1 starts to cultivate the thin of the 4th batch
Born of the same parents, reactor 1 is completed first batch cell culture (such as the 14th day) within the period of (2) or (3) step at this time, and
And reactor and compounding system completion are cleared out a gathering place preparation (such as the 20th day), therefore can start the cell culture of new lot.
... circulation carries out as described above.
Although with the innovation of technology, the optimization of technique, associated period may change, technology of the existing technology
Problem includes: not only to need to carry out preparation of clearing out a gathering place to the reactor line, it is also necessary into one after the production of a certain batch products
Walk that general culture medium preparing tank clear out a gathering place and prepare that the production of next batch can be carried out in the reactor line, reactor and
The time of clearing out a gathering place of culture medium compounding system makes the operation of any bar reactor line be unable to reach seamless connection.
In addition, also resulting in following technical problem using excessive reactor line:
(1) equipment cost in reactor line is high, will obviously increase equipment cost using a plurality of reactor line；
(2) every reactor line is required to manning's operation and maintenance, and manpower employs cost also higher；
(3) when producing different types of product, also it is unfavorable for contamination control and production procedure control from the angle of GMP；
Utility model content
The purpose of this utility model includes providing the biology that a kind of cost reduces, process is controllable, market adaptability to changes improves
The production system of product, to solve the above problem in the prior art, specific technical solution is as described below.
On the one hand, the utility model provides a kind of production system in biological products workshop.The production system includes one
A or multiple biological products Workshop Production units.
In some schemes, the production unit includes production line, culture medium preparation module and on-line cleaning system/dress
It sets, the production line successively includes media to cell culture modules, isolates and purifies module from upstream to downstream, and the culture medium prepares module
Culture medium is provided for media to cell culture modules, at least two reactor lines is equipped in the media to cell culture modules, isolates and purifies module
Interior to isolate and purify line at least provided with one, the processing capacity for isolating and purifying line is greater than or equal to the production of single reactor line
It can, wherein culture medium prepares module and is independently equipped with dedicated culture medium preparing tank to each reactor, and described online clear
The system of washing is provided at least two sets.
It is described to isolate and purify module and isolate and purify line equipped with one in some specific embodiments.
In some specific embodiments, the on-line cleaning system or on-line cleaning device are three sets.
In some specific embodiments, it is equipped between a cell culture in the media to cell culture modules.
It is equipped in some specific embodiments, in the media to cell culture modules between a cell culture and one pre-
It stays between cell culture.
In some specific embodiments, set that there are two between cell culture in the media to cell culture modules.
In some specific embodiments, two reactor lines are equipped between the cell culture in the media to cell culture modules.
In some specific embodiments, the separation and purification treatment ability for isolating and purifying line is equal to single reactor line
Production capacity.
In some specific embodiments, the separation and purification treatment ability for isolating and purifying line is between Single cell culture
The sum of the production capacity of interior all reactor lines.
In some specific embodiments, the biological products workshop is monoclonal antibody workshop.
In some specific embodiments, the utility model provides a kind of production unit in monoclonal antibody workshop comprising raw
Producing line, culture medium prepare module and on-line cleaning system, the production line from upstream to downstream successively include media to cell culture modules,
Module is isolated and purified, the culture medium prepares module and provides culture medium for media to cell culture modules, sets in the media to cell culture modules
There are two reactor lines, isolates and purifies in module and isolate and purify line equipped with one, the processing capacity for isolating and purifying line is equal to
The production capacity of single reactor line, wherein culture medium prepares module and is independently equipped with dedicated culture medium preparation to each reactor
Tank, and the on-line cleaning system is provided with three sets.
In some specific embodiments, the production unit is run according to following scheme: according to specific interval time
Enable each reactor line in turn, and after the cell culture period that each reactor line completes a batch, using it is multiple
It clears out a gathering place while line cleaning system is to the reactor and its preparing tank, and carries out next batch preparation and cleared out a gathering place with completing one
Preparatory period, enable the reactor again then to complete the cell culture period of a new batch, reciprocation cycle, when the interval
Between are as follows: (cell culture period+clear out a gathering place the preparatory period)/reactor quantity is greater than or equal to purification cycle in the interval time
Under the premise of, take its minimum value.
In some specific embodiments, the production unit is run according to following scheme: according to specific interval time
Two reactor lines are enabled in turn, after the cell culture period that each reactor line completes a batch, using multiple online
It clears out a gathering place while cleaning system is to the reactor and its preparing tank, and carries out the preparation of next batch production to complete one
It clears out a gathering place the preparatory period, enables the reactor again then to complete the cell culture period of a new batch, reciprocation cycle, between described
Every the time are as follows: (cell culture period+clear out a gathering place the preparatory period)/reactor quantity, the reactor quantity are 2.
On the other hand, the utility model provides a kind of biological products workshop or it produces plot structure, including between preparing, it is thin
Between born of the same parents' culture, between chromatography, between ultrafiltration and on-line cleaning system, culture medium preparing tank, the cell are equipped in the preparation
It is equipped at least two reactor lines in culture, is equipped with processing capacity in the chromatography and is produced more than or equal to single reactor line
The tomographic system of energy, the interior ultrafiltration system for being greater than or equal to single reactor line production capacity equipped with processing capacity of the ultrafiltration, institute
The product unification stated at least two reactor lines is isolated and purified through tomographic system and ultrafiltration system, wherein in preparation
Dedicated culture medium preparing tank is independently equipped with to each reactor, and the on-line cleaning system is provided at least two sets.
In some specific embodiments, the on-line cleaning system is three sets.
In some specific embodiments, the quantity between the cell culture is one.
In some specific embodiments, the quantity between the cell culture is two.
In some specific embodiments, two reactor lines are equipped between the Single cell culture.
In some specific embodiments, it is equal to the layer of single reactor line production capacity in the chromatography equipped with processing capacity
Analysis system, the interior ultrafiltration system for being equal to single reactor line production capacity equipped with processing capacity of the ultrafiltration.
In some specific embodiments, the processing capacity of the tomographic system and/or ultrafiltration system is individual cells training
Support the sum of the production capacity of interior all reactor lines.
In yet another aspect, the utility model provides raw using the biological products production unit or biological products production district
The method for generating Tetramune.
In some schemes, biological products described in the utility model include but is not limited to the engineering using different expression systems
Cell, such as bacterium, yeast, insect, plant and mammalian cell, prepared protein, polypeptide and its derivative, including
Cell factor, plasminogen activity factor, the recombinant plasma factor, growth factor, fusion protein, enzyme, receptor, hormone
With monoclonal antibody etc.；It also include the endogenous protein for the one pack system extracted from human or animal tissues；And gene therapy product,
Allergen product is extracted by the tissue or body fluid of human or animal or by the biologically active more of fermentation preparation
The biological products such as ingredient formulation, Tiny ecosystem product.In some embodiments, the biological products are monoclonal antibodies.
At least there is following advantages in the production system in the biological products workshop of the utility model:
(1) utilization rate of reactor line is improved, higher production efficiency can reach with less reactor quantity, and
Therefore the cost of reactor valuableness is reduced.
(2) between by the way that reserved cell culture is arranged, so that workshop scale is easier to be enhanced production capacities according to market situation；And
When using between two cell culture, two groups of reactor lines can produce different types of product, and compatibility is strong.
(3) pollution risk is effectively reduced.
Explanation of nouns
Cell culture period: single end stage reactor completes the time of a batch cell culture.
It clears out a gathering place the preparatory period: after single end stage reactor completes a batch cell culture, the reactor and its corresponding
The life of the scavenging period of culture medium preparing tank its corresponding culture medium preparing tank investment next batch cell culture with the reactor
The sum of antenatal time.
Isolate and purify the period: a batch cell culture for single whole stage reactor isolates and purifies line and is chromatographed
With the time of the processing such as ultrafiltration.
Interval time: multiple end stage reactors are when enabling in turn, the enabling time of enabling time adjacent two reactors
Difference.
Detailed description of the invention
The layout that embodiment 1 produces production system in plot structure is shown in Fig. 1
The layout that embodiment 2 produces production system in plot structure is shown in Fig. 2
The layout that embodiment 3 produces production system in plot structure is shown in Fig. 3
Specific embodiment
Embodiment 1
The production plot structure in monoclonal antibody workshop, including culture medium prepare module, media to cell culture modules, isolate and purify module and
Line cleaning system, media to cell culture modules divide including being equipped with three reactor lines in each cell culture between a cell culture
One is equipped with from purification blocks and isolates and purifies line, and culture medium prepares module and is uniformly equipped with a set of culture corresponding to all reactor lines
Base compounding system, the quantity of on-line cleaning system are a set of.
Specifically, as shown in Figure 1, wherein culture medium preparation module is located in culture medium preparation, for the cell of upstream
Culture provide culture medium, isolate and purify module include chromatography between ultrafiltration, wherein chromatography between include chromatography one Room and chromatography two
Room, the present embodiment isolate and purify line i.e. by the tomographic system being set between chromatography and the ultrafiltration system group being set between ultrafiltration
At wherein tomographic system includes two groups, is located at two Room of one Room of chromatography and chromatography.In addition, media to cell culture modules and separation are pure
Change and is additionally provided with a centrifuge between module.The quantity of on-line cleaning system be it is a set of, can be successively to single reactor line and training
Base preparing tank is supported to be cleaned.
Production system in the production plot structure of the present embodiment is run according to following scheme: being taken turns according to specific interval time
Stream enables 3 reactor lines, and after the cell culture period that each reactor line completes a batch, using single online
Cleaning system clears out a gathering place the preparatory period to the preparation that successively carries out clearing out a gathering place of the reactor and its preparing tank to complete one, then opens again
The cell culture period of a new batch, reciprocation cycle are completed with the reactor.
In cell culture, the cultivation cycle of reactor is 14 days, and reactor and culture medium compounding system are cleared out a gathering place and prepared
Time be 6 days, the sum of every period be 20 days, isolate and purify in purification cycle be 7 days.When using 3 reactor lines,
Batch interval time can be foreshortened into minimum, interval time is limited by purification cycle at this time, therefore interval time counted according to 7 days
(calculating process: interval time is assumed to be N days between batch, and batch 1 and batch 4 use No. 1 reactor production line, so batch 4 for calculation
Time started need to be later than batch 1 and clear out a gathering place and prepare the end time.That is 3N+1 >=20, N >=6.Batch interval time is limited by this time
Purification cycle, purification cycle are 7 days, i.e. batch interval time N=7).Such as reactor line 1-3 usually comes in the following way
Operation:
(1) reactor 1 starts to cultivate the cell of first batch；
(2) after a specific batch interval time (7 days), reactor 2 starts to cultivate the cell of second lot；
(3) after two specific batch interval times (14 days), reactor 3 starts to cultivate the cell of third batch；
(4) after three specific batch interval times (21 days), reactor 1 starts to cultivate the cell of the 4th batch, this
When reactor 1 first batch cell culture (such as the 14th day) is completed within the period of (2) or (3) step, and react
Device 1 and the completion of culture medium compounding system are cleared out a gathering place and are prepared (the 20th day), therefore reactor 1 can start new lot after the 21st day
Cell culture.
Reactor 2, reactor 3, reactor 1 ... is enabled again according to the similar mode of (4) step to recycle as described above
It carries out.
The relevant parameter of the present embodiment is as follows:
Cell culture: 3 × 2000L reactor line
Isolate and purify: 1 × 2000L isolates and purifies production line
Every batch of production scale is 2000L, and amount of formulation is 2.5 ten thousand/batches.The bioreactor culture period be 14 days, theoretically between
It is had to be larger than 5 days (3 × interval time >=14 day) every the time, consideration is cleared out a gathering place and the sum of time is 6 days, at this time interval time
It is limited to purification cycle, is carried out according to 7 days batch of optimization schemes, at actual production 300 days, the output value is as shown in table 1.
1 embodiment of table, 1 capacity data table
Embodiment 2
The production plot structure in monoclonal antibody workshop, including culture medium prepare module, media to cell culture modules, isolate and purify module and
Line cleaning system, media to cell culture modules divide including being equipped with two reactor lines in each cell culture between a cell culture
One is equipped with from purification blocks and isolates and purifies line, and culture medium prepares module and is respectively equipped with a set of culture corresponding to every reactor line
Base compounding system, the quantity of on-line cleaning system are three sets, and wherein culture medium compounding system is a set of, and reactor is a set of, separates pure
It is a set of to change module (containing centrifuge).
Specifically, as shown in Fig. 2, wherein culture medium preparation module is located in culture medium preparation, including two sets are cultivated
Base compounding system, the respectively cell culture (two reactor lines) of upstream provide culture medium, and isolating and purifying module includes chromatography
Between between ultrafiltration, wherein including two Room of one Room of chromatography and chromatography between chromatography, the utility model isolates and purifies line i.e. by being set to
Tomographic system between chromatography and the ultrafiltration system being set between ultrafiltration composition, wherein tomographic system includes two groups, is located at layer
Analyse two Room of a Room and chromatography.In addition, media to cell culture modules and isolating and purifying and being additionally provided with a centrifuge between module.On-line cleaning
The quantity of system is three sets, can be cleaned simultaneously to single reactor line and its culture medium preparing tank.
Production system in the production plot structure of the present embodiment is run according to following scheme: being taken turns according to specific interval time
Stream enables two reactor lines, and after the cell culture period that each reactor line completes a batch, using multiple online
It carries out clearing out a gathering place while cleaning system is to the reactor and its preparing tank and prepares to clear out a gathering place the preparatory period to complete one, then open again
The cell culture period of a new batch, reciprocation cycle are completed with the reactor.
In cell culture, the cultivation cycle of reactor is 14 days, since reactor and preparing tank can clear out a gathering place simultaneously
Prepare, reactor and culture medium compounding system clear out a gathering place and the preparatory period is 3 days or so, the sum of every period is 17-18 days, is divided
It is 7 days or so from the purification cycle in purifying.Although, can be by batch interval time theoretically when using 3 reactor lines
Minimum is foreshortened to, but since reactor line is expensive, to save cost, 2 reactor lines are used only in the present embodiment, when interval
Between calculated according to 10 well-to-do (optimization scheme can be compressed to 8-9 days) days.Such as reactor line 1-2 is usually according to following
Mode is run:
(1) reactor 1 starts to cultivate the cell of first batch；
(2) after a specific batch interval time (10 days), reactor 2 starts to cultivate the cell of second lot；
(3) after two specific batch interval times (20 days), reactor 1 starts to cultivate the cell of third batch, this
When reactor 1 be completed within the period of (2) step first batch cell culture (the 14th day), and reactor and culture medium
Preparing tank completion is cleared out a gathering place preparation (the 18th day), therefore reactor 1 is enough to start the cell culture of new lot after the 20th day.
Reactor 2, reactor 1, reactor 2 ... is enabled again according to the similar mode of (3) step to recycle as described above
It carries out.
The relevant parameter of the present embodiment is as follows:
Cell culture: 2 × 3000L reactor line
Isolate and purify: 1 × 3000L isolates and purifies production line
Every batch of production scale is 3000L, and amount of formulation is 3.75 ten thousand/batches.The bioreactor culture period be 14 days, theoretically between
It is had to be larger than 7 days (2 × interval time >=14 day) every the time, consideration is cleared out a gathering place and time, according to 10 days batch of optimizations
Scheme carries out.
2 embodiment of table, 2 capacity data table
As it can be seen that even if according to well-to-do time interval scheme, production capacity of the production capacity of the present embodiment also compared with embodiment 1 is bigger.
Embodiment 3
The production plot structure in monoclonal antibody workshop, including culture medium prepare module, media to cell culture modules, isolate and purify module and
Line cleaning system, the media to cell culture modules is including being equipped with two reactors between two cell culture in each cell culture
Line isolates and purifies module equipped with one and isolates and purifies line, and culture medium prepares module and is respectively equipped with one corresponding to every reactor line
A culture medium preparing tank, the quantity of on-line cleaning system are three sets.
As shown in figure 3, the production plot structure of the present embodiment is specifically laid out similar embodiment 2, newly established relative to embodiment 2
Between one cell culture, and separation and purification treatment ability correspondingly improves one times.
Concrete configuration is as follows:
Cell culture: 22 × 3000L reactor lines (between the cell culture different positioned at two)
It isolates and purifies: 1 6000L production line
Every batch of production scale is 6000L, and amount of formulation is 7.5 ten thousand/batches, crossing operation between batch.The bioreactor culture period is
14 days, theoretically interval time had to be larger than 7 days (2 × interval time >=14 day), and consideration is cleared out a gathering place and time, according to 10 days
Batch of optimization scheme carries out.
3 embodiment of table, 3 capacity data table
Claims (7)
1. a kind of production unit in improved biological products workshop comprising production line, culture medium prepare module, buffer
Module and on-line cleaning system, the production line successively include media to cell culture modules, isolate and purify module from upstream to downstream, institute
It states culture medium preparation module and provides culture medium for media to cell culture modules, the buffer module provides to isolate and purify module
Buffer, the media to cell culture modules is interior to be equipped at least two reactor lines, isolates and purifies in module and separates at least provided with one
Line is purified, the processing capacity for isolating and purifying line is greater than or equal to the production capacity of single reactor line, which is characterized in that culture medium
It prepares module and dedicated culture medium preparing tank independently is equipped with to each reactor line, and the on-line cleaning system is set as
Two sets, three sets or more sets.
2. production unit according to claim 1, it is characterised in that the culture medium prepare module, media to cell culture modules and
It isolates and purifies module and is equipped with on-line cleaning system.
3. production unit according to claim 1, it is characterised in that it is thin to be equipped at least one in the media to cell culture modules
Between born of the same parents' culture, selectively, it is additionally provided in the media to cell culture modules between at least one reserved cell culture.
4. production unit according to claim 1, it is characterised in that cell is trained there are two setting in the media to cell culture modules
Between supporting.
5. according to the described in any item production units of claim 3-4, it is characterised in that each of described media to cell culture modules
Two reactor lines are equipped between cell culture.
6. production unit according to claim 5, it is characterised in that the separation and purification treatment ability for isolating and purifying line
The sum of the production capacity of all reactor lines interior equal to Single cell culture.
7. production unit described in one of -4 according to claim 1, it is characterised in that the biological products include cell factor, fibre
Fibrillarin dissolves proenzyme activity factor, the recombinant plasma factor, growth factor, fusion protein, enzyme, receptor, hormone and/or monoclonal
Antibody.
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| CN201821076809.2U CN208917203U (en) | 2018-07-09 | 2018-07-09 | The production unit in improved biological products workshop |
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| CN201821076809.2U CN208917203U (en) | 2018-07-09 | 2018-07-09 | The production unit in improved biological products workshop |
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