source：this site date:2015-5-6
On May 6, 2015, mass media group hosted the Yellow River delta morning post reporter Sun Chuan, for our company profile, product research and development, the development planning of FanKe, general manager of our company for the interview, and in 2015 in the Yellow River delta morning post on May 7, the first edition A10 was reported. The following is the report content:
Also degree of biological after the end of 2017 and put into production will become the first in the province has a vaccine production capacity of enterprises
Can produce 5 million doses of wild dog vaccine a year
In shandong province is the largest pharmaceutical, but because the vaccine production technology, the objective conditions, such as demand is higher, so has been no one in vaccine production enterprises in shandong province." Biological technology co., LTD., general manager of shandong also degrees FanKe said, at present, the company developed with rabies vaccine is under state inspection, and its east eight-channel production base is under construction and completed and put into operation, also degree of biological will become the first family with rabies vaccine production enterprises in shandong.
Combining with the demand of the market on rabies vaccine development
"People with rabies vaccine market is very wide, not to say the market never saturated, has been in short supply." FanKe introduction, this short supply with strict government regulation, market demand is big, there is a direct cause such as production is difficult.
In 2009 countries to improve the vaccine products inspection standard, who was not up to standard is allowed before the vaccine products factory, at the same time, different from ordinary drugs, vaccine products factory USES is "issued by batch. "Ordinary drugs from the factory just reach a certain standard, and 'issued by batch system, each batch products are through in the factory when court compulsory inspection, audit, inspection is unqualified or audit has not been approved, shall not be listed factory." FanKe said.
Under the strict standards of the state, the country is now capable of producing enterprise only 12 with rabies vaccine, the 12 companies of rabies vaccine production capacity is far cannot satisfy the demand of the market. "According to the national related department data released, at present our country each year to 20 million doses of rabies, but last year only around 9 million doses of rabies vaccine factory." FanKe, said the remaining demand is mainly rely on imports.
In addition to the above reasons, the rising demand also is the main reason that rabies unsaturated market. Dog, cat breeding increases quickly in recent years, the number of people hurt by the small animals is also increasing. FanKe said, once bitten by dogs and cats, must inject rabies vaccine as soon as possible. "In addition to cats and dogs, by some other animal bites, scratches and best injection of rabies vaccine to prevent".
Using human diploid cells develop vaccines To ensure the quality of the vaccine
According to reports, production technology of rabies vaccine after the non purified hamster kidney vaccine, purified hamster kidney vaccine, animal cell culture and purification of vaccine, animal cell tank culture evolution, development is very rapid, and also degree of biological production of rabies vaccine currently used is microcarrier reactor mode of production. "This mode of production is currently recognized as one of the most promising animal cell culture technology, the production process to achieve the full closed, automatic control, pipeline process, the vaccine's safety indicators have reached the international advanced level." Fan Ke introduction, at present, the company has applied for 1 patents and 8 utility model patents.
In addition to the introduction of advanced production technology, but also the biological company has been in a variety of innovative experiments. "We now have a number of well-known domestic research institutions to maintain a cooperative relationship, common in the field of vaccine to seek a breakthrough." Fan Ke introduction, in the development of rabies vaccine, and the degree of cooperation with the scientific research unit to carry out drug delivery platform, human diploid cell culture vaccine and other two studies.
"The current injection of rabies vaccine is intramuscular injection, we are studying without the use of needle intradermal injection now." Fan Ke said to the drugs do not need to use an injection, the pain to be smaller, "the biggest advantage is that this way is intradermal injection, vaccine can be faster in the human body to produce antigen, the effect will be better, after a successful research and development, can not only applied to the rabies vaccine, but also can be suitable for most of the vaccine injection.
Fan Ke believes that the current rabies vaccines are mostly animal cell culture, can be used in human diploid cell culture rabies vaccine companies only one, but the output has been unstable, the state of the vaccine in the animal DNA residues have strict regulations, standards increase after DNA residues from the original 1 ng (NG) increased to 100 Peake (PG)." Fan Ke said, this standard, some of the company's vaccine products are substandard, and the use of human diploid cell culture vaccine will completely avoid this problem.
The DPT vaccine A domestic precedent
"The rabies vaccine is a relatively mature vaccine for us, but we are not just limited to rabies vaccine, we will continue to promote the development of other types of vaccine products on this basis." Fan Ke said that currently also degree of biological vaccine production base is construction, is expected to will be put into operation by the end of 2017, base with an annual output of people with 500 million copies of rabies vaccine, adsorbed no cell DPT vaccine 200 million copies of the production capacity.
It is understood, the degree of biological rabies vaccine is currently undergoing state inspection, the related materials also is the National Center for drug evaluation review, after obtaining the relevant approval, rabies vaccine will in the completion of the production base for mass production. Rabies vaccine continues to advance at the same time, degree of biological adsorption without cell DPT vaccine also has completed the technical reserves, will become the focus of rabies vaccine.
"We study the DPT vaccine is adsorbed component DPT vaccine. Currently, there are no similar products listed." Fan Ke introduction, the vaccine is the use of column chromatography pertussis was divided into Pt and FHA individually extracted out, according to a certain proportion of mixed of making components pertussis vaccine, again with diphtheria and tetanus toxoid mixture mixing preparation groups of DPT vaccine, "the production of vaccine varieties with stable product quality, batch small differences, good controllability, immunization effect, less side effects characteristics."
On the market prospects for vaccine products, Fan Ke said very much looking forward to, the market demand itself, the high quality of the company's products will be a powerful weapon to open up the market."