Freeze-drying process method for preparing human rotavirus live vaccines by adopting MA104 cells
A technology of rotavirus and process method, applied in the field of human vaccine research and development, can solve the problem of rotavirus infection without specific treatment drugs, etc., and achieve the effect of improving stability
Inactive Publication Date: 2018-03-02
SHANDONG YIDU BIOTECH
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However, there is no specific treatment for rotavirus infection, and vaccine is the first choice to prevent and control rotavirus infection
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[0020] A kind of freeze-drying process method that MA104 cell prepares human rotavirus live vaccine, described process step is:
[0021] 1) The unpurified rotavirus vaccine stock solution is mixed with excipients and protective agents to make a semi-finished product and start to pre-freeze;
[0022] 2) Put the pre-canned vials with semi-finished products, the specification is 0.5ml / cart, on the shelf of the freeze dryer, select a representative vial, put in the temperature probe and eutectic point detection probe, and carry out Pre-freezing: Cool down from 25°C to 0°C for 12.5 minutes at a rate of 2°C / min, and maintain for 60 minutes; cool down from 0°C to -20°C for 10 minutes at a rate of 1°C / min, and Maintain for 60 minutes; cool down from -20°C to -40°C for 10 minutes at a rate of 1°C / min, and maintain for 120 minutes;
[0023] 3) Use 30 minutes to reduce the vacuum in the freeze dryer to 0.1mbar, and maintain the actual vacuum between 0.15mbar and 0.2mbar;
[0024] 4) Af...
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The invention provides a freeze-drying process method for preparing human rotavirus live vaccines by adopting MA104 cells. The freeze-drying process method comprises the following steps: mixing an unpurified rotavirus vaccine stock solution with an excipient and a protective agent, thus preparing a semi-finished product, and carrying out pre-freezing; placing a penicillin bottle pre-filled with the semi-finished product on a shelf of a freeze-drying machine, placing a temperature probe and a eutectic point detection probe, and carrying out pre-freezing; maintaining the actual vacuum degree tobe 0.15mbar-0.2mbar by using the duration of 30min; after the vacuum degree is constant, carrying out temperature rising on the shelf in four stages, namely, from -40 DEG C to -35 DEG C, from -35 DEGC to -25 DEG C, from -25 DEG C to -15 DEG C, and from -15 DEG C to -5 DEG C; carrying out further vacuumizing; and raising the temperature to 15 DEG C-25 DEG C within 60min, maintaining the temperature for 200min-400min, and carrying out capping under the vacuum state and delivering from storage, thus obtaining the product. The freeze-drying process method has the advantages that the stability ofthe human rotavirus live vaccines prepared by adopting the MA104 cell culture is improved, so that the long-term storage and transportation of the human rotavirus live vaccines are facilitated, in addition, the raw materials are easily available, and the problems of collapse, atrophy, hard shell formation and wall hanging are avoided.
Description
technical field [0001] The invention relates to the technical field of research and development of vaccines for human use, in particular to a freeze-drying process for preparing live rotavirus vaccines for human use from MA104 cells. Background technique [0002] Rotavirus is the main cause of diarrhea in infants and young children in autumn and winter. Almost all children have been infected with rotavirus before the age of 5, and there are about 111-135 million cases of rotavirus diarrhea worldwide each year, resulting in about 650,000 infant deaths. However, there is no specific treatment for rotavirus infection, and vaccine is the first choice to prevent and control rotavirus infection. [0003] Rotavirus is not suitable for general tissue culture, so special cell line MA104 (rhesus monkey embryonic kidney cells) needs to be selected for culture, but there are the following problems: First, the stock solution made of MA104 cell culture rotavirus has not been purified. ,...
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IPC IPC(8): A61K9/19A61K39/15A61K47/10A61K47/26A61K47/42A61P31/14
Inventor 樊可
Owner SHANDONG YIDU BIOTECH