PDD: L13 Biotechnology Products

Introduction to Biotechnology Products

• Diagnostic and therapeutic products derived from … organisms

• Produced using … DNA technology, cell culture, or other biotechnological methods

• Includes peptides, proteins, monoclonal antibodies, antibody drug conjugate, vaccines, gene and cell therapies

living, recombinant

What are the 5 classification of biotechnology products?

Monoclonal antibodies or antibody drug conjugate, therapeutic proteins, vaccines, gene therapies, and cell-based therapies

Handling, Storage, and Administration:

• Strict cold chain requirements (commonly …℃)

• Avoid … unless specified (mRNA vaccines requires -… to -… ℃; CAR-T cells require storage in liquid nitrogen, typically below -…℃)

• … protection for some biologics

• Do not vigorously … — may break nucleic acids or denature protein products

• Often administered via … (IV, SC) by trained personnel

2-8, freezing, 20, 80, 140, Light, shake, injection

General Composition of Biotechnology Products:

• Active ingredient: … protein, antibody, gene, or cells

• Excipients: …, stabilizers, cryoprotectants

• … (for multi-dose vials)

• … provided for reconstitution (if lyophilized)

• Formulated to maintain … and biological activity

recombinant, buffers, Preservatives, Diluent, stability

Which of the following best describes biotechnology products?

a. Synthetic chemicals made by organic synthesis

b. Products derived from living organisms using biotechnological methods

c. Inorganic compounds used in diagnostics

d. Herbal products

b

Trastuzumab is classified as:

a. Vaccine

b. Monoclonal antibody

c. Cell therapy product

d. Gene therapy

b

How should most biotechnology products be stored?

a. At room temperature only

b. Strict cold chain, commonly 2–8℃

c. In a freezer at -70℃ for all products

d. Heat sterilized before use

b

Which route of administration is most common for monoclonal antibodies?

a. Oral

b. Topical

c. Intravenous (IV) or subcutaneous (SC)

d. Inhalation

c

In cryopreserved CAR-T therapy, DMSO is used to:

a. Maintain isotonicity

b. Provide energy source

c. Act as a cryoprotectant during freezing

d. Serve as an active ingredient

c