Biological products, or biologics, are medical products made from sugars, proteins, nucleic acids, or living entities like cells and tissues. They are used to treat, cure, prevent, or diagnose diseases. Biologics are made from natural sources through complex production processes involving cell culture, purification, analysis, and formulation. Examples include vaccines, monoclonal antibodies, and products for cancer, arthritis, and skin/nerve conditions. Their production requires tightly controlled conditions to consistently produce safe, pure, and potent products.

2. Biologicals
0 Biological products, or biologics, are medical products.
0 Biological products could be made of sugars, proteins, or
nucleic acids or complex combinations of these
substances, or may be living entities such as cells and
tissues.
0 Like drugs, biological products are used to either: treat
or cure diseases and medical conditions,
0 prevent diseases, or
0 diagnose diseases
0 Biological products are made from a variety of natural
sources.

3. Growing importance of biotech
medicines
0 Biotechnology medicines have been proven to be safe and
effective with an excellent record of patient satisfaction
and safety
0 Biotechnology has produced medicines for some of the
most serious and intractable diseases

4. Sources Of Biologicals
Mammalian cell cultue
Humans
Avian cell culture
Mice
Transgenics
Insect cell culture

5. Types of Biological Products
Hormones Proteins Cytokines
Monoclonal
antibodies
Allergenic
Extracts
Cellular &
Gene
Therapies
Xenotrans
plantation
Products
Vaccines

6. Biological product different from
drugs

7. Size and complexity

8. Examples of biologicals
Biological products are used for a wide range of diseases
and conditions, including serious and life-threatening
conditions such as cancers and rheumatoid arthritis. Some
examples of biological products are :
0 Botox: has both dermatologic and neurologic uses
0 Herceptin: for a certain type of breast cancer
0 Vaccines, for example: the Shingles vaccine and the flu
vaccines
0 Enbrel: for rheumatoid arthritis and psoriasis

9. Steps Involved In Production
stDevelop Host
• A host cell is developed by isolating the DNA
sequence that codes for the desired protein,
Establish a Cell
Bank
• A cell bank is then established using elaborate
cell screening and selection process
Protein
Production
System
• The “engineered” cells are then cultured on a large
scale under growth conditions to optimize cellular
production
Purification
• Fractions containing the desired protein are
harvested and isolated, and the undesired proteins
and impurities are separate
Analysis • Protein molecules are analyzed for uniformity in terms
of structure, character, and potency;
Formulation • Therapeutic protein is then formulated

10. Challenges for Biological
Products
0 Must be processed under tightly controlled
conditions/controls throughout production to
consistently produce a safe, pure, and potent product,
0 Preclude the introduction of environmental
contamination
0 Biological products may be susceptible to extreme
temperatures and light typically need refrigeration but
may need frozen storage or preservatives
0 Shelf life may be limited