19. IMMUNOLOGICAL PRODUCTS

Immunological Products in Pharmaceutics:

Immunological products are special biological preparations used to protect the body from infections or to treat certain diseases. These products work by boosting or modifying the body’s immune response. The major immunological products include sera, vaccines, and toxoids. Because they directly affect the immune system, they are prepared with high safety and purity standards.


Types of Immunological Products:

  • Sera
  • Vaccines
  • Toxoids

Sera

Sera (also called antiserum) are biological products that contain ready-made antibodies. These antibodies help fight toxins, infections, or venoms. Sera give immediate protection, also known as passive immunity.

Examples of Sera

  • Anti-tetanus serum
  • Anti-venom serum (snake bite)
  • Anti-rabies serum
  • Diphtheria antitoxin

Uses of Sera

  • To neutralize toxins
  • To treat emergency conditions like snake bites
  • To provide instant immunity when vaccines cannot work fast

Manufacturing of Sera

The general steps include:

  • Select a healthy animal (usually horse)
  • Inject small doses of toxin or antigen to stimulate antibody production
  • Collect blood from the immunized animal
  • Separate serum containing antibodies
  • Purify and test for safety
  • Fill into sterile containers

Vaccines

Vaccines are biological preparations that stimulate the body to produce immunity against specific diseases. Unlike sera, vaccines provide long-term protection by stimulating active immunity.

Types of Vaccines

  • Live attenuated vaccines – weakened microbes (e.g., MMR vaccine)
  • Killed/inactivated vaccines – killed microbes (e.g., Polio – IPV)
  • Toxoid vaccines – inactivated toxins (e.g., Tetanus toxoid)
  • Subunit vaccines – purified parts of microbes (e.g., Hepatitis B)
  • mRNA vaccines – teach cells to produce protective proteins (e.g., COVID-19 mRNA vaccines)
  • Vector-based vaccines – safe viruses used to deliver antigens (e.g., Adenovirus vaccines)

Uses of Vaccines

  • Prevent infectious diseases
  • Control outbreaks and epidemics
  • Protect children, adults, and high-risk groups
  • Reduce disease severity and complications

General Manufacturing Process of Vaccines

Steps may differ depending on vaccine type, but usually include:

  • Selection of microbe/antigen
  • Culture and growth under controlled conditions
  • Inactivation or attenuation (weakening) if required
  • Purification of antigen
  • Mixing with stabilizers or preservatives
  • Quality control tests for safety, potency, and sterility
  • Filling in sterile vials or syringes

Toxoids

Toxoids are modified toxins. The toxin produced by bacteria is treated with heat or chemicals so that it becomes non-toxic but still able to produce immunity. They give strong and long-lasting protection.

Examples of Toxoids

  • Tetanus toxoid
  • Diphtheria toxoid

Manufacturing of Toxoids

  • Collect toxin produced by bacteria
  • Treat with heat or formaldehyde to remove toxicity
  • Purify the toxoid
  • Add stabilizers if needed
  • Perform safety and potency testing
  • Fill into sterile injectables

Differences at a Glance

ProductWhat It ContainsType of ImmunityExamples
SeraReady-made antibodiesPassive immunityAnti-venom, anti-rabies
VaccinesMicrobes or antigensActive immunityHep B, Polio, MMR
ToxoidsInactivated bacterial toxinsActive immunityTetanus toxoid

Importance of Immunological Products

  • Help prevent life-threatening infections
  • Boost body’s natural defense system
  • Control epidemics and pandemics
  • Reduce disease-related deaths
  • Used in both treatment and prevention
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