It is an exciting time to manufacture peptides and oligonucleotides, molecules used in countless medicines undergoing rapid change and growth.
We've looked at some of the driving forces behind this development and why it benefits chemical manufacturers of these complex molecules collectively known as TIDES.
Peptides have long been a therapeutic niche product but are becoming increasingly important in medicine as active ingredients. Oligonucleotides are also playing an increasingly important role in drug development.
The rising interest in TIDES molecules has numerous aspects. They all favor peptides, oligonucleotides, and the chemical synthesis of TIDES.
A NEW GENERATION OF DIABETES DRUGS FROM PEPTIDES CAN ONLY BE PRODUCED BY CHEMICAL SYNTHESIS
The largest peptide-based drugs by volume to date have been used against diabetes. These include compounds such as semaglutide and liraglutide. Like the therapeutic proteins, in the past, these have been produced in large quantities in cell cultures (recombinant DNA production). The development of manufacturing processes using recombinant DNA technology is complex and limited to incorporating encoded amino acids. Recombinant DNA technology is the preferred manufacturing method for proteins and peptides with particularly long sequences.
CHEMICAL MANUFACTURING OF TIDES IS BECOMING MORE COST-COMPETITIVE - EVEN FOR GENERICS OF ACTIVE INGREDIENTS WHOSE PATENTS ARE EXPIRING
Thanks to the ongoing development of manufacturing technology, chemical production of APIs such as semaglutide or liraglutide is now possible. In addition, these peptide active ingredients will lose patent protection soon. This allows companies like
PEPTIDES ARE ADVANCING INTO NEW DISEASE AREAS
New approvals are on the horizon. Currently, over 40 peptide-based drugs are in Phase 3 of clinical development for treating various diseases, such as the eye condition Geographic Atrophy. Clinical research is also ongoing for a peptide therapy for Inflammatory Bowel Disease. Both are diseases for which there are often inadequate medical treatments to date. These new advancements in peptide therapies will enable us to address important unmet medical needs and bring new therapeutic options to millions of undertreated patients worldwide.
OLIGONUCLEOTIDES ARE GROWING - AND SHOW LONG-TERM POTENTIAL BEYOND RARE DISEASES
Currently, 15 oligonucleotides are approved, but research with oligonucleotides is in full swing in the pharmaceutical industry. Around 13 approvals could be added in the next five years. So far, this class of APIs has played a role primarily in the fight against rare diseases. However, inclisiran, approved for treating hypercholesterolemia, is the first oligonucleotide drug in the starting blocks that could be important for larger patient groups.
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The next few years will bring opportunities and challenges and will be incredibly exciting.
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