The document discusses biopharmaceuticals, including their definition, types (like vaccines and gene therapies), and their manufacturing practices under Good Manufacturing Practices (GMP). It details the various categories of vaccines, the process of allergen immunotherapy, and the significance of quality control in biopharmaceutical production. Overall, it emphasizes the importance of adhering to GMP guidelines to ensure high-quality and safe biopharmaceutical products.

1. Biopharmaceutical
Products, GMP,
Manufacturing Facilities
for Biopharmaceuticals
Nikitha Polineni
Tanvi Potluri
Varshaniyah Ravishankar

2. BIOPHARMACEUTICAL
PRODUCTS

3. Biopharmaceuticals
• Any medicinal product manufactured in or
extracted from biological sources.
• Biologics can be composed of sugars, proteins or
nucleic acids or complex combinations of these
substances, or may be living entities such as
cells and tissues.
• Examples of biopharmaceuticals
include vaccines, blood or blood
components, allergenics, somatic cells, gene
therapies, tissues, recombinant therapeutic
protein and living cells.

4. Vaccines
• A vaccine is a biological preparation that
improves immunity to a particular disease.
• A vaccine contains an agent that resembles a
disease-causing microorganism.
• Often made from weakened or killed forms of
the microbe, its toxins or one of its surface
proteins
• The agent stimulates the body's immune
system to recognize the agent as foreign,
destroy it, and keep a record of it.

5. Vaccines
• Two categories- Prophylactic (Prevention of a
disease) and Therapeutic (Treatment of a
disease).

6. Types of vaccines
• Inactivated: Inactivated but previously
virulent. Rabies, Polio, Influenza
• Attenuated: Live, virulence reduced. Measles,
Rubella, Mumps
• Toxoid: Inactivated toxins. Tetanus,
Diphtheria
• Protein subunit: A fragment of micro-
organism is used. Hepatitis B (contains only
surface proteins), HPV (capsid)

7. Allergenics
• An allergen is a type of antigen that produces
an abnormally vigorous immune response in
which the immune system fights off a
perceived threat that would otherwise be
harmless to the body.

8. Allergens (Contd.)
• Allergen immunotherapy- A person is
gradually vaccinated with progressively larger
doses of allergens.
• Allergy Testing

9. Gene therapy
• Gene therapy is the use of nucleic acid polymers
as a drug to treat disease by therapeutic delivery
into a patient's cells
• Expressed as proteins, interfere with the
expression of proteins, or possibly even correct
genetic mutations.
• Two types- Somatic gene therapy, Germ line gene
therapy.
• Viral vectors are commonly used.
• Non viral gene therapy includes injection of naked
DNA, electroporation, gene gun, sonoporation,
etc

10. Biosimilars
• Medical products whose active drug is made
by living organisms.
• Called “Innovator Biopharmaceutical
products”
• Follow on manufactures do not have access
to original molecules or fermentation
techniques.
• Copies of biological drugs are made
(generics)

11. Other products
• Somatic cells
• Hormones
• Recombinant DNA
• Important enzymes
• Proteins (Interferon, TNF)

12. GOOD
MANUFACTURING
PRACTICES

13. Good Manufacturing Practices
• Practices required in order to conform to
guidelines recommended by agencies that
control authorization and licensing for
manufacture and sale of food, drug products
and active pharmaceutical products.
• Ensure high quality and do not pose any risk to
consumer or public.
• Organizations like FDA, WHO.
• In India Schedule M of Drug and Cosmetic Act
specifies the current practices (CGMPs) to be
followed.

14. Basic Guidelines in GMP
1. Hygiene: Facility must maintain a clean and
hygienic manufacturing area.
2. Controlled Environment: To prevent cross
contamination of one product from another
drug or particulate matter.
3. Defined Manufacturing process: Manufacturing
processes are controlled and changes are to be
evaluated.
4. Instructions and procedures are written in clear
and unambiguous language.

15. GMP Guidelines (Contd.)
5. Operators are to be trained to carry out and
document their work and procedures.
6. Records are to be maintained manually or
by instruments and all steps are to be
documented.
7. Proper labeling and distribution system
should be in place.
8. A system should be available for recalling
any batch or supply.

16. GMP Guidelines (Contd.)
9. Complaints about marketed drugs should be
examined; the causes of quality defects
investigated and appropriate measures to
prevent recurrence should be undertaken.
10. Practices are recommended with the goal of
safeguarding the health of patients.

17. GMP (Contd.)
• GMP guidelines are not prescriptive instructions
on how to manufacture products.
• They are a series of general principles that must
be observed during manufacturing.
• When a company is setting up its quality
program and manufacturing process, there may
be many ways it can fulfil GMP requirements.
• It is the company's responsibility to determine
the most effective and efficient quality process.