SHILPI MEHROTRA, SONALI JOSHI
Kline Chemicals & Materials, India

Abstract

A surging number of biologics and their penetration into multiple therapies create an attractive market for pharmaceutical chemical suppliers, but not one without challenges. With high safety and efficacy, biologics are treating major chronic and complex diseases, and enjoying good approval rates. However, their development and formulation is challenged by high R&D investment, longer approval times, stringent manufacturing process, and difficult regulatory pathways. 

The selection and use of the right specialty chemicals are extremely critical for biologics because they are not only key components of the finished drug dosage but are also crucial in the development and manufacturing of the biologic drug itself. To fully understand the role of ingredients in this market, it is imperative to assess the entire production process of biologics.

IMPORTANCE OF BIOLOGICS

Biopharmaceuticals include a wide variety of products derived from human, animal, or microbial source with the help of biotechnology. Biopharmaceuticals (commonly called “biologics”) are artificially created through a production system and function like a real biological component. 

They can also be extracted from biological sources, such as blood plasma. They can be broadly classified into three categories: biologics (novel biological drugs), biosimilars (generic versions of novel biologic drugs), and bio-betters (developed based on a reference drug with some innovation in both active and inactive ingredients).

Biologics are the most advanced therapeutics available for treatment of numerous diseases and conditions. They are currently available to treat many life-threatening and life-altering diseases like cancer, rheumatoid arthritis, multiple sclerosis, and many rare diseases for which there were no previous treatment options. Immunology disorders, diabetes, and cardiovascular disorders are other therapeutic areas where biologics are proving to be very effectiv ...