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

Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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Page 1: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

Biopharmaceutical Products, GMP, Manufacturing Facilities for

BiopharmaceuticalsNikitha Polineni

Tanvi PotluriVarshaniyah Ravishankar

Page 2: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

BIOPHARMACEUTICAL PRODUCTS

Page 3: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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.

Page 4: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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.

Page 5: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

Vaccines

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

Page 6: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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)

Page 7: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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.

Page 8: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

Allergens (Contd.)

• Allergen immunotherapy- A person is gradually vaccinated with progressively larger doses of allergens.

• Allergy Testing

Page 9: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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

Page 10: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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)

Page 11: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

Other products

• Somatic cells• Hormones• Recombinant DNA• Important enzymes• Proteins (Interferon, TNF)

Page 12: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

GOOD MANUFACTURING

PRACTICES

Page 13: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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.

Page 14: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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.

Page 15: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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.

Page 16: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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.

Page 17: Biopharmaceutical Products, GMP, Manufacturing Facilities for Biopharmaceuticals

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.