Question 1a

Just like any other vaccines ever made, the dtap (diphtheria, tetanus, pertussis)
vaccine contain almost the same ingredients of tiny fragments of the disease-
causing organism. they also contain other ingredients to keep the vaccine safe
and effective.

The step-by-step process of making a dtap vaccine are Exploratory, Preclinical

safety and Efficacy, Clinical safety and Efficacy in humans, Regulatory Review
and Approval lastly Production scaling up. In the first stages of production
exploratory research is conducted in search for antigen to include in the
vaccine. It might take long to identify the exact antigen to use and can take up
to about 2 to 5 years

Preclinical safety and Efficacy, once the antigen is identified, tests are
conducted to asses vaccine candidates’ immunogenicity which is their ability to
elicit the desired immune response. Other areas of focus during this stage
include shot term toxicology, formulation and development of a scalable,
efficient and reproducible manufacturing process. The data collection and
analysis can take up to 2 years

The next stage is Clinical safety and efficacy in humans, so before proceeding
to this stage an application for an Investigational New Drug (IND) is submitted
to Food and Drug Administration (FAD). It is only when IND and FAD have
approved can the vaccine proceed through the three phases of testing in
humans. Phase one which can take 2 years where less than hundred volunteers
are administered the vaccine to determine whether it is safe to proceed to
phase 2 and also to determine whether a sufficient immune response is
provoked.
Phase 2, this can take up to three years whereby a larger group of subjects
(human trials) receive the vaccine. On this stage will be taking a close look at
the safety, immunogenicity, doses, immunization schedules and delivery
methods of the vaccine.

Phase three which can be five years long to conduct, this involves thousands of
people in whom the vaccine safety and efficacy are tested. During this trial
there will be monitoring of potential side effects in subjects, determining
whether the vaccine can help to prevent the disease and testing if it leads to
the production of antibodies against the specific pathogen.

Step four of the production of the dtap vaccine sis Regulatory Review and
Approval license, if the vaccine is determined to be safe and effective then a
Biologics License Application is submitted to Food and Drug Administration
(FAD) which conducts its own testing of the vaccine. The FAD also inspects the
production of the vaccine and monitors its safety and purity and the entire
process can take up to 2 years

Lastly is production scaling up of the vaccine, manufacturing scales up

production of large quantities of the vaccine ensuring all products meets the
necessary regulatory requirements. The vaccines will contain 2-
phenoxyethanol a preservative which prevent the vaccine from becoming
contaminated once the vial has been opened that’s if it will be used to
vaccinate more than one person. The preservative is used in many baby care
products and is safe for use in vaccines

Sugar stabilizer such as lactose and sucrose are also required as it prevent
chemical reaction from occurring within the vaccine and to keep components
from sticking to the vaccine vial the container. Lastly to have a complete
vaccine, surfactants are placed in the vaccine to keep the ingredients blended
together and also to prevent settling and clumping of elements that are in the
liquid form of the vaccine.

Question b

Quality control is no single step process in the entire production of the

vaccines, it must be present at every single stage so a quality control system
should be adopted and involves the following characteristics. Traceability
which is the ability to track the product from its raw material state to the
finished product. Secondly is standardization, standards are set at each stage
of production and measuring the product against these standards. Lastly is
communication, effectively communicating quality control information
between all members of the production team.

Quality control can be defined as a system of maintaining standards in

manufactured products by testing a sample of the output against the
specification.

The system will be monitoring the approved suppliers list, ingredient

specification, product information and recipe, manufacturing procedures and
product testing.

The quality control system will firstly focus on the approved suppliers before
focusing on the manufacturing process. Having an approved suppliers list of
raw materials is how to ensure only suppliers who can meet the company’s
quality standard are used. Quality raw material produces quality products in
simple sense so the approved suppliers list should be reviewed and updated
regularly and secondly focus on physical contamination, chemical
contamination, microbial, contamination, allergens and physical objects first
and the will focus on ingredient.
Another point to consider is product formulation and recipe, every formular
used in the production of the product is documented as well as the recipe is
kept filed with list of ingredients and their quantities. This is to ensure that
every product have the same formulation with each and every product being
produced in the company and to prevent the recipe from being disrupted that
is keeping the quality of the product identical.

Even manufacturing procedures, this covers all production aspects from

ingredient handling to packaging and labelling. Employees should follow these
procedures strictly to ensure that products everything that is on the all of the
products that meet the company’s quality standards.

Product testing this ensure the quality of the product is kept at the standards
of the company. All the products are tested for compliance with quality
specifications before they are released for sale.

The system will also be monitoring the physical contamination which may
occur when objects end up in food products this can happen at any stage but is
mostly likely during packaging. To prevent this, make sure that all packaging
materials are clean and inspect products before they are packaged. for further
assurance of quality clean products, metal detectors are used. This equipment
is sensitive, reliable, cost effective and ensures protection from even the
smallest ferrous, non-ferrous and stainless-steel contaminants.

Chemical contamination occurs when harmful chemicals come into contact

with products, the vaccines. It can happen during storage or transportation if
the products is not properly protected from chemical exposure. To prevent this
product are stored in clean, dry conditions and away from any potential
sources of contamination.

Microbial contamination happens when bacteria or viruses contaminate food

product and can happen at any stage but is most likely to occur during
processing or packaging. This is prevented by disinfecting all the equipment
and properly training employees in safety procedures. X ray inspection system
is then used to make sure the product is gem free.

Allergens are when a product contains an allergen not listed on the label and
can happen if allergens are not properly controlled during production or a
cross contamination between products. To prevent a cross contamination
between products during production, the products are stored separately.

In contrast quality control system are available to ensure the best quality of
the vaccines. By following these procedures employees prevent and correct
quality problems, ensuring product excellence and customer satisfication.