The Biotechnology Innovation Machine: A Source of Intelligent Biopharmaceuticals for the Pharma Industry—Mapping Biotechnology’s Success

Abstract

The marriage of biotechnology and the pharmaceutical industry (pharma) is predicated on an evolution in technology and product innovation. It has come as a result of advances in both the science and the business practices of the biotechnology sector in the past 30 years. Biotechnology products can be thought of as "intelligent pharmaceuticals," in that they often provide novel mechanisms of action, new approaches to disease control, higher clinical success rates, improved patient care, extended patent protection, and a significant likelihood of reimbursement. Although the first biotechnology product, insulin, was approved just 32 years ago in 1982, today there are more than 200 biotechnology products commercially available. Research has expanded to include more than 900 biotechnology products in clinical trials. Pharma is substantially engaged in both the clinical development of these products and their commercialization.

An overview of FDA-approved biologics medicines

“…A commonly held view is that biologics are generally safer and have shorter approval times (and, by inference, costs) for clinical development [11,12]. With this in mind, the average time of clinical development [the time from investigational new drug (IND) submission until FDA approval] for all NMEs approved since 1982 (the year Humulin 1 was approved) was analyzed.…”

Generic Drug Distribution in India-Issues and Challenges

“…Pharmaceutical industry comprises of various pharmaceutical companies that deal in these drugs and variety of medical devices that are used in health sector. These are governed by various rules and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs prior to the launch of these products in the market [2].…”

Liquid–liquid extraction of biopharmaceuticals from fermented broth: trends and future prospects

“…One of the most controversial definitions refers to biopharmaceuticals, but as Walsh clearly elucidated, a biopharmaceutical should be defined as ‘a protein or nucleic acid based pharmaceutical substance used for therapeutic or in vivo diagnostic purposes, which is produced by means other than direct extraction from a native (non‐engineered) biological source’ . Thus, biopharmaceuticals include recombinant proteins (enzymes, hormones, interleukins, interferons, growth factors and blood factors), recombinant and engineered synthetic peptides, monoclonal antibodies (mAbs), cell and tissue therapies, genetic therapies (genes and antisense and inhibitory RNA fragments), recombinant and molecularly engineered vaccines and other expressing recombinant molecules (for example, polymers, liposomes, fusion protein and mAb fragments and derivatives) . As can be seen, biopharmaceuticals include a diversity of biomolecules, and therefore, the production of these compounds can involve a wide range of methods, ranging from microorganisms to transgenic animals, used as heterologous expression systems.…”