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Which of the following is NOT true about proteins?

Proteins are generic versions of brand-name biologics. (correct)

Proteins are responsible for cellular structure and function.

Proteins are made by cells.

Enzymes are an example of proteins.

What is the main function of proteins in cells?

To produce enzymes.

To carry out vital physiological functions. (correct)

To provide cellular structure.

To synthesize brand-name biologics.

What organelles in cells are responsible for making proteins?

Mitochondria

Golgi apparatus

Nucleus

Ribosomes (correct)

What is the correct order of steps in protein synthesis?

Transcription, translation, post-translational modifications Signup and view all the answers

Why is understanding protein folding important?

To determine protein function Signup and view all the answers

Which of the following is NOT a function of proteins in the body?

Proteins storing information in the DNA Signup and view all the answers

What is the first step in protein synthesis?

Transcription of DNA into RNA Signup and view all the answers

What determines the final structure of a protein molecule?

The order of amino acids in the chain Signup and view all the answers

What happens when proteins do not fold properly in the human body?

They may cause disease Signup and view all the answers

What is post-translational modification of proteins?

The chemical modification of proteins after they are produced Signup and view all the answers

Which of the following is a common type of post-translational modification?

Glycosylation Signup and view all the answers

Which of the following is NOT a function of post-translational modifications?

Determining a protein's primary structure Signup and view all the answers

Which of the following is NOT a function of proteins?

Regulating gene expression Signup and view all the answers

Which of the following is a function of therapeutic proteins?

Replacing missing proteins Signup and view all the answers

Which regulatory bodies recognize the wide range of biologics?

All of the above Signup and view all the answers

Which type of drug is Herceptin?

Biologic Signup and view all the answers

What is the main difference between small molecule drugs and biologics?

Small molecule drugs are chemically synthesized in the lab, while biologics are made in living cells Signup and view all the answers

Why are biologics more difficult and expensive to manufacture compared to small molecule drugs?

Biologics have a more complex structure Signup and view all the answers

What is the size difference between a monoclonal antibody and aspirin?

Monoclonal antibodies are about 750 times larger than aspirin Signup and view all the answers

What are biosimilars?

Follow-on biologics Signup and view all the answers

Which agency uses the following criteria to determine if a therapeutic protein is a biosimilar medicine?

EMA Signup and view all the answers

What is a biosimilar?

A biologic drug produced using a different cell line and process than the brand-name product Signup and view all the answers

What is the main difference between small molecule drug generics and biosimilars?

Small molecule drug generics are easy to prove identical to the brand-name drug, while biosimilars are difficult to prove identical to the brand-name biologic Signup and view all the answers

What is the EMA's requirement regarding the name, appearance, and packaging of a biosimilar medicine?

They must differ from reference biological medicinal products to distinguish between the two Signup and view all the answers

What do the FDA and EMA both conclude about biosimilars that are highly similar to the reference product?

They are likely to have the same clinical result Signup and view all the answers

Which one of the following correctly defines biomanufacturing?

The process of making biologic drugs Signup and view all the answers

What is the main difference between the manufacturing process of small molecule drugs and biologics?

Small molecule drugs are made using chemicals, while biologics are made using living organisms or their components Signup and view all the answers

Which of the following correctly lists the steps used in biomanufacturing in their correct order?

Purification, synthesis, formulation Signup and view all the answers

What is the difference between the master cell bank and the working cell bank?

The master cell bank contains cells used for production, while the working cell bank contains cells used for testing Signup and view all the answers

How can different master cell lines, with the same gene, produce different proteins?

The proteins are modified after production Signup and view all the answers