Testing of Raw Materials for Recombinant Protein Vaccines

Recombinant protein vaccines are a type of vaccine that does not contain a complete pathogen and is prepared from specific protein antigens produced in a heterologous expression system. Common heterologous expression systems include bacteria, mammalian cells, plant cells, and insect cells. The appropriate heterologous expression system often needs to be selected based on the type of antigen produced. Recombinant protein vaccines have several major advantages such as good safety, strong stability, and low cost, which have received widespread attention from researchers in recent years. At present, recombinant protein vaccines have been widely used in various infectious diseases, such as prevention of hepatitis B virus (HBV), tetanus, pertussis, influenza and so on.

 

However, in addition to the active ingredients of recombinant protein vaccines, everything from cell cultivation to reagent purification can't do without the help of raw materials and excipients, which play a key role in the production and quality control of vaccines. Common excipients include stabilizers, preservatives, buffers, adjuvants, and various other additives used to enhance the safety and effectiveness of the vaccine. For example, adjuvants can help enhance the immune response, while stabilizers can help maintain the stability of the vaccine and prevent it from losing its effectiveness during storage and transportation.

 

For the analysis of raw materials and excipients of recombinant protein vaccines, the main methods used are high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS). These methods can effectively analyze the types and content of various raw materials and excipients in the vaccine, ensuring the quality and safety of the vaccine. For instance, HPLC can be used to analyze the adjuvants and stabilizers in the vaccine, while MS can be used to analyze the trace elements and potential impurities in the vaccine. Through these methods, we can fully understand the quality of the vaccine and its possible effects on the human body.

 

MtoZ Biolabs provides a fast and efficient excipient detection technology package based on advanced mass spectrometry and chromatography platforms combined with a professional technical team. All you need to do is tell us your experimental purpose and send the samples. MtoZ Biolabs is responsible for all follow-up projects, including sample processing, on-board analysis, data analysis, and project reports. Feel free to consult.