Manufacturing vaccines: From identification of raw materials to quality control

Manufacturing vaccines: From identification of raw materials to quality control


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  • Source: Metrohm India Private Limited

  • Date: 04 Dec,2021

A vaccine, also known as an immunization, involves injecting a weakened version of a disease into a person’s body, which produces antibodies or immunity against the illness. Vaccination has successfully eradicated a number of diseases, like polio and smallpox, that were once deadly.

Vaccinations play a vital role in maintaining sustainable health of people in various countries; hence, they are used in disease-prevention strategies across many regions.

In recent years, vaccinations have been in demand due to an increase in the incidence of viral and bacterial infections. The majority of vaccinations are administered to people of different age groups to boost their immune systems and protect them against a broad range of infectious diseases throughout their entire lives.

Since the COVID-19 outbreak, most pharmaceutical companies are focusing on developing diagnostics, treatments, health technologies, and vaccines related to COVID-19, as well as exploring the potential of existing treatments.

The global vaccines market will be impacted by all of these factors as well.

As the world is still reeling under the scourge of Corona virus, countries all over the world are waiting for vaccines to vaccinate their citizens to ensure immunity and to prevent the spread of this contagious infection.

Importance of vaccines can be understood with the fact that vaccines over a period of last many years has not only saved many lives, but also helped the countries to eradicate viral diseases like polio.

Development, Testing, and Regulation of Vaccines:

Developing and manufacturing of vaccine is a long and painstaking process which might take years before a successful final product is released. Often taking 10 to 15 years, and both the public and private sectors are involved.

During the entire process it is very important to ensure that each and every step of the process complies with the norms of Good Manufacturing Process standards.

In order to meet strict safety standards, Metrohm’s analytical Instruments offers highly precised analytical instruments for your vaccine testing or analysis.

Metrohm, as a leading manufacturer of analytical instruments, offers not only the most advanced equipment, but also complete solutions for any task.

Our experienced professionals have developed custom applications for you in every aspect of regulatory compliance with our expert service. You will discover in the following article how Metrohm ensures the quality and safety of measurements during vaccine development process.

Karl Fischer Titration: For the determination of the water content in lyophilisates in vials.

During Karl fischer titration a solvent (methanol) is injected into the vial to dissolve the sample and extract the water (ultrasonic bath). Afterwards the contents of the vial are transferred to the titration vessel to carry out the automatic determination.

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Ion Chromatography: Determination of polyribosylribitol phosphate (PRP) in Haemophilus influenzae vaccine.

Haemophilus influenzae type B (Hib) is a major cause of bacterial meningitis in children in many countries.

The capsular polysaccharide (PS) of Hib plays an important role in the virulence of the organism. Current methods to determine PS content in vaccines such as Hib are imprecise and unreliable, especially if the vaccine contains a sugar stabilizer (e.g. lactose).\

Ion chromatography with pulsed amperometric detection (IC-PAD, or HPAEC-PAD) offers a simpler procedure and better sensitivity than other assays to quantify PS (in this white paper, polyribosylribitol phosphate [PRP]) in Hib vaccine.

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Raman Spectroscopy for Vaccine Manufacturing:

Raman spectroscopy as a technique can be useful right from the identification of Raw Materials to the final vaccine product. Raman spectrometers can be used for identification of active ingredients, preservatives, adjuvants, antibiotics etc.

Metrohm and B&Wtek offers a range of Raman spectrometers which includes hand held systems and portable Instruments. These systems comes with a choice of either 785nm laser or 1064nm laser, wide range of sampling accessories, 21CFR Part 11 compliant software’s and IQ/OQ support.

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