Biologics

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. 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.

Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

TECHNOLOGY ANDA APPROVALS

Outline: CMC for Biologics

Outline: CMC for Vaccines

Biologics, Biosimilars, and FDA Approval Process

Overview: Antibody Manufacturing Process

Continuous Manufacturing Process - Therapeutic Proteins

Excipients used in Antibody Products

Excipients used in mRNA vaccines

2023 Biological License Application Approvals

Players in Biosimilar Industry

mRNA Vaccines, Manufacturing and Development Process


COMPANIES (PRODUCT PIPELINE) 

Alvotech (02/01/2024)

Moderna (01/10/2024)

Pfizer (02/03/2024)


PRODUCTS

STELARA(R) (ustekinumab) injection

EYLEA (aflibercept) injection