Covid-19 technical support to solve research and development problems

 The Covid-19 is composed of a complete virus, and its pathogenicity is inactivated through physical and chemical methods, while still maintaining all or part of the immunogenicity of the virus. The candidate vaccine is prepared through inactivation verification and purification processes. After vaccination, the viral antigen can stimulate the body to produce an immune response and produce antibodies to achieve a protective effect. my country has a good foundation for research and development of inactivated vaccines. At present, many domestic research institutions and companies are intensively developing new crown inactivated vaccines.

COP vials

"The vaccine inspection cycle takes longer than other drugs." said Xiang Jinzhong, chief reviewer of the Department of Pharmacy of Biological Products of the Center for Drug Evaluation. For this reason, the State Drug Administration's special affairs office supports applicants in advance The hospital conducts inspection and quality standard review of inoculation sub-banks, clinical samples, etc., and does a good job of docking with the China Inspection Institute on quality review and other related work to save vaccine inspection time.

In accordance with the requirements of emergency inspections, the China National Inspection Institute intervened in vaccine research and development in advance. For new vaccines developed in emergency situations, the task of communicating vaccine quality standards and inspection-related issues with the research and development unit has been several times heavier than usual.

effervescent tablet packaging

Undertaking the inspection task of the new crown inactivated vaccine is the Li Changgui team of the respiratory virus vaccine room of the National Inspection Institute and the technical backbones such as Xu Kangwei and Quan Yaru. "There are four companies involved in the research and development of inactivated vaccines, and the characteristics and conditions of each research and development product are different. Therefore, the quality standards and inspection methods of each product need to be more targeted." Li Changgui said that the team used technical reserves to Prepared and purified goat anti-new crown virus, goat anti-new crown virus Spike protein, rabbit anti-new crown virus, rabbit anti-new crown virus Spike protein, rabbit anti-new crown virus Spike protein RBD region and other antibodies, and provided them to many inactivated vaccine manufacturers to establish The antigen content detection method has laid a foundation for advancing the process of vaccine research and development and ensuring vaccine quality.

The virus seed is the basis for the development and preparation of vaccines, and the quality of the virus seed directly affects the safety and effectiveness of the vaccine. Li Changgui introduced that because there is no high school and titer antiserum, companies cannot perform virus identification, mycoplasma, and foreign factor testing. Therefore, the team adopted multiple approaches and multiple immunization strategies, and took the lead in preparing high-titer antiserum from SPF rabbits, which was used in the detection of virus species used in production by all domestic enterprises, solving the problem of virus species quality control. ——Enable enterprises to accelerate the conditions for applying for registration and inspection.

The in vivo efficacy test of the vaccine directly reflects the effectiveness of the vaccine. However, this experiment needs to be completed in a P3 laboratory (three-level biosafety protection laboratory), and the number of domestic P3 laboratories is far from meeting the needs of many R&D teams . "At that time, the detection methods established in the early stages of all companies needed to be tested by virus neutralization experiments, which had a high biosafety risk. The team and the company jointly tackled key problems and tested total antibodies after immunizing mice, establishing that no P3 is required. In vivo efficacy testing methods in laboratories.” He said that this testing method makes vaccine development progress no longer restricted by the number of laboratories.

Layout in advance and continuously solve multiple problems, laying the foundation for emergency inspection. On March 15, Beijing Kexing Zhongwei Biotechnology Co., Ltd. sent the first batch of inactivated vaccines for the new crown, and the China National Inspection Institute quickly launched the inspection. Take the respiratory virus vaccine room of the National Inspection Institute as an example. Up to now, 36 batches of new crown inactivated vaccines, 18 batches of original solutions and 4 batches of placebo have been tested by 4 R&D units, accounting for 132 batches of vaccines and For 44% of the original solution and placebo/control, 42 inspection reports have been issued, creating a prerequisite for China's new crown inactivated vaccine to enter clinical trials in the world.

(Source: National Center for Drug Administration and Evaluation)

Blood glucose test strips packaging way

 Blood glucose test strips have been into people's daily life, the most important part of test strips is mold, mold is active with water and oxygen around, so packaging manufacturer must consider the way to protect the test strips. Now test strips on the market have two way packaging, one is single way, another is tube with desiccant cap.

84mm test strips tube

Glucose test strips container can contain ten, fifty or more pieces, which can simplify then filling way for test strips manufacturer. For plastic tube, water vapor transmission rate can not avoid. So desiccant can be incorporated into the cap or directly into the polymer matrix to provide moisture protection. The flip-top closure provides consumer appeal, ergonomics and likelihood of closure for prolonged protection.

The importance of effervescent packaging

 The main design of the effervescent tablet tube is the packaging of the effervescent tablet, which is moisture-proof and anti-damage. When the effervescent tablet is packaged early, it is the most prominent dryness of the package. There is a spiral spring to prevent the effervescence from being damaged during transportation.

effervescent tubes

Precautions for the production and packaging of effervescent tablets:

1. Do not make the acid and alkali together with the main drug during granulation, because the general acid or alkali will affect the stability of the drug and may lead to unqualified degradation products.

2. The disintegration degree is not more than 5 minutes according to the pharmacopoeia, which is relatively easy to achieve. Our internal control standard is 90 seconds. When granulating, use a binder with a low viscosity and use a high concentration of ethanol to granulate (such as absolute ethanol), so that it dries quickly, the particles are relatively loose, and the degree of disintegration is easily qualified. But pay attention to the friability, the pharmacopoeia stipulates no more than 1%. (But it seems that a special application can be made for effervescent tablets, which should be relaxed appropriately.) Finally, acid and alkali are added as additional auxiliary materials in the final mixing.

3. Be careful not to store the prepared pellets for too long, and control the humidity.

4. The humidity should also be controlled during tablet pressing to prevent water absorption.

5. As for packaging, you can choose double aluminum packaging or high-density polyethylene bottle or PP plastic bottle packaging that is not easily permeable to water and oxygen to ensure its stability.

Which May Cause Desiccant Tube Date Error

 The reason of desiccant tube date error has been confiromed. Confirmation is not laboratory test error caused by excessive, is indeed the quality of products after exceeding the standard. The investigation phase of exceeding standard is transferred from the quality control laboratory to the production related department, and the reasons can be divided into the following three kinds:

effervescent packaging

First, deviation of non production process: deviation of test results caused by operator's failure to operate equipment or wrong material.The deviation is investigated by professionals in the quality department, the production department or the equipment management department.

sprial desiccant  closure

Second, production process deviation refers to the deviation of the inspection results caused by the defects of the production process, even if the personnel operation, equipment and materials are correct. The deviation should be investigated by professionals familiar with and familiar with the process technology.

the produce process for desiccant tube

Third, if the material itself brings the deviation, the survey is divided into two cases: first, the factory inspection deviation. First of all by the quality department and supply department investigation, receiving temporary process if there is deviation, the absence of such a material manufacturer shall notify the investigation of its production and storage process without bias, and investigate whether there is any deviation in the transport process.The two is if the factory inspection qualified, in the use or storage process deviation, should be the quality department and supply department investigation storage conditions and weighing process whether there is deviation.

The data record is clear, do not do well documented, product appearance, desiccant tube manufacturers can gain a foothold in the messy. 

Covid-19 Vaccine Science carries out clinical effectiveness evaluation

 On April 13, April 27, and May 13, following the inactivated vaccine developed by Wuhan Research Institute, Beijing Kexing Zhongwei Biotechnology Co., Ltd., Beijing Institute of Biological Products, Chinese Academy of Medical Sciences Medical Biology The new inactivated vaccines developed by the Institute have successively obtained clinical trial approvals.

vitamin c tube

'After the vaccine enters the clinical trial stage, it is necessary for the drug regulatory department to strengthen the supervision of the clinical trial process, scientifically carry out clinical safety and effectiveness evaluation, supervise the applicant to perform the main responsibility, and strengthen the safety information reporting and risk management in the clinical trial process.' According to Wang Haixue, head of the Clinical Trial Management Office, in order to ensure the quality of clinical trials and protect the rights and interests of subjects, the Center for Drug Evaluation formally issued the "Regarding Strengthening the Clinical Trial of New Coronary Pneumonia Vaccines" The Notice on Trial Safety Information Report and Risk Management clarifies the applicant’s main responsibility for clinical trials, requires the applicant to carry out clinical trials in strict accordance with the clinical trial management specifications and the requirements of clinical trial approval documents, establish a complete pharmacovigilance system, and formulate a complete Risk control measures, strengthen the quality control of clinical research samples, timely report the phased progress of clinical trials, set up a data security monitoring committee, conduct risk communication in a timely manner, and recommend long-term safety observations for subjects.

desiccant cap

'The Clinical Trial Management Office communicates with applicants daily to master vaccine clinical trial progress, case enrollment status and safety information. At the same time, it strengthens communication among vaccine review indication teams, conducts risk analysis and assessment, and establishes an efficient According to incomplete statistics, according to incomplete statistics, according to incomplete statistics, according to incomplete statistics, except for the daily report of clinical trial progress and safety information, according to Wang Haixue, only one new crown vaccine research and development institution/company is taken as an example. In addition, the Center for Drug Evaluation also conducted 14 special communications with the applicant.

COP  vials

In order to strengthen the applicant's timely and dynamic risk monitoring and evaluation of safety information, the Clinical Trial Management Office of the Center for Drug Evaluation also drafted a report form that summarizes clinical research progress and safety information, and determined a clear, unified and standardized safety information report. Applicants are required to report the number of participants in clinical trials and the status of SAE and SUSAR on a daily basis for the content and format of the trial; and it is recommended to submit phase I and II clinical trial data as soon as possible, in order to timely evaluate vaccine early clinical trial data, and accelerate the promotion and support of vaccine follow-up Development of clinical research.

At the same time, the Center for Drug Evaluation is actively discussing with domestic and foreign experts and industry R&D personnel on the basic conditions for the approval of the new crown vaccine for marketing and the phase III clinical protection efficacy trial design and implementation strategies, in order to reach consensus and obtain relevant information. With the support of all parties, we will make every effort to promote the early listing of the new crown vaccine.

How Can Plastic Vitamin Tube Keep Dry Environment

Plastic vitamin tube is used in vitamin tablet packaging due to its dry environment. There are silical-gel desiccant and large molecular sieve desiccant in plastic vatimin tube. However, silica-gel desiccant is the only one through FDA and healthy for human.

spiral desiccant closure

Silica-gel desiccant in vitamin tube is a highly active adsorbent material, which belongs to amorphous material. Silic-gel desiccant of vitamin tube cap insoluble in water, non-toxic and tasteless, chemically stable. According to diameter, silica can be divided into macroporous silica gel, coarse - hole silica gel, type B silicone, fine - hole silica gel. Silica can reuse through rebirth. The main ingredient of silica-gel desiccant is Sio2, for more translucent amorphous, composed of natural mineral processed granular or bead, usually after treatment with sulfuric acid to form, its hard, non-toxic, tasteless, non-corrosive, good chemical stability and thermal stability.

plastic vitamin C tube

Silica-gel desiccant of vitamin tube covers many hydroxyl groups with strong hydrophilicity, at the same time, the surface of silica gel desiccant has many small holes that are not visible to the naked eye, so that its surface area is greatly increased, and the properties of silica gel desiccant decide to become a good desiccant.Desiccant moisture environment as temperature of the shelf life is most suitable for 20 ~ 32 ℃, humidity was 60% ~ 60%, it can reduce the environmental relative humidity to 40%.

Xinfuda as a China major pharmaceutical packaging manufacturer with DMF, which can offer excellent desiccant packaging for vitamin tablets. Plastic vitamin tube adopted silica-gel desiccant to keep dry and the spring on the cap can prevent tablets damaging.

How to Choose Vitamin C Tubes

Vitamin C tubes belongs to a special pharmaceutical packaging in the international, which has strong professionalism. The sealed fitting of bottle body and cap is important for avoiding vitamin C tablets wetting. It is the key step for vitamin C tablet manufacturer to choose suitable packaging. Except sealing, there are also some points need to pay attention.

 

 

effervescent packaging 

 

First, surface: Color uniform, no damage, no oil, good match.

Second, the moisture content of the drying agent:lower than 4.8%.

Third, anti-fall: desiccant must not be dropped

Fourth, board: moisture content below 6%, no fluorescence reaction, heavy metal less than 5 parts per million.

Fifth, dissolution: heavy metals, oxides and non-volatile substances.

Sixth, microorganisms: bacteria less than 1000, mould yeast less than 100, escherichia coli may not be detected.

Seventh, abnormal toxicity should not be detected.

 

 

 

144mm plastic vitamin c tube

 

VC tablets tube has an important part is that spiral desiccant cap, spiral desiccant cap is the international univerisal cap for effervescent tablets, the structure has high requirement for mould design, even some countries can not volum production. The spiral in the cap can buffer the impact of the transport process, thus protecting fragile effervescent tablets will not be damaged.

The selection of high-quality vitamin C tubes will also need to analyze the strength, equipment and comprehensive quality of the manufacturers, and the high quality of the enterprise products will be stable, which will help your products to be more smooth in the competition.