Biotechnology-Based Pharmaceuticals
Recombinant DNA, protein therapeutics and how biotech drugs are made
Pharmaceutical biotechnology uses living organisms and biological systems to manufacture medicines. From recombinant insulin to mRNA vaccines, biotech drugs now represent a rapidly growing proportion of new medicines — and understanding how they are made is increasingly essential for pharmacists.
What is Pharmaceutical Biotechnology?
Pharmaceutical biotechnology refers to the use of living organisms or their components to manufacture medicines. It includes recombinant proteins (like insulin and growth hormone), monoclonal antibodies, vaccines, gene therapy, and antisense oligonucleotides. Most new medicines approved today are biotechnology-based rather than traditional small-molecule chemical drugs. The field has transformed medicine by making it possible to produce human proteins safely and at scale.
Types of Biotech Medicines
Biotech medicines include: recombinant hormones and growth factors (insulin, erythropoietin, growth hormone), clotting factors (Factor VIII for haemophilia), interferons and interleukins (immune modulators), vaccines (hepatitis B, HPV), monoclonal antibodies (trastuzumab, adalimumab), and newer technologies like antisense oligonucleotides and gene therapy. mRNA vaccines, used in COVID-19 immunisation, represent the newest class — instructing the body's own cells to produce an antigen.
Why Make Drugs Using Biotechnology?
Before recombinant technology, many proteins had to be extracted from human or animal sources — a process with major limitations. Insulin came from pig and cow pancreas (limited supply, immunogenic). Growth hormone was extracted from human pituitary glands — until cases of Creutzfeldt-Jakob Disease (CJD) emerged from contaminated cadaveric extracts. Blood clotting factors from pooled human plasma spread HIV and hepatitis C. Recombinant technology solved these problems: unlimited supply, human-identical sequences, and freedom from contamination risks.
How are Biotech Drugs Produced?
Recombinant DNA technology involves identifying the gene encoding the desired protein, inserting it into a plasmid vector, and transforming it into a host cell. The host cell then expresses the protein, which is extracted, purified, and formulated. Careful evaluation of the suitable host cell system is critical — bacteria (E. coli) are fast and cheap but cannot add sugar chains (glycosylation) to proteins; yeast can do some glycosylation; mammalian cells (like CHO cells) provide human-like glycosylation needed for complex proteins like erythropoietin and monoclonal antibodies.