Biopharmaceuticals and xenobiotics

What are the differences between pharmaceuticals produced via chemical synthesis and stem cell-based biopharmaceuticals? Why is the efficacy and safety of novel therapies superior to traditional ones?

Xenobiotics

• Steroidal anti-inflammatory drugs (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs) are xenobiotics – chemical compounds produced via chemical synthesis which do not occur naturally in mammals.
• Their constituent substances include steroidal anti-inflammatory drugs (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs).
• Treatment with SAIDs and NSAIDs is symptomatic, limited to reducing inflammation and reducing pain – they are not designed to induce regenerative processes.
• When used against conditions caused by underlying chronic inflammation they exhibit a singular mechanism of action such as COX-2 enzyme inhibition. This alleviates inflammation, but also causes adverse reactions (e.g. gastrointestinal microbleeds), and the chronic drug use required by the treatment raises the likelihood of such reactions to a significant level.
• Their long-term use for chronic osteoarthritis may cause numerous adverse reactions, including Cushing’s syndrome, muscle atrophy, hepatitis or ulceration of gastric mucosa.

Stem cell-based biopharmaceuticals

• Stem cell-based biopharmaceuticals bring new quality and technological challenges at the manufacturing and quality control stages: due to its complexity, the entire production is under continuous monitoring, while quality control requires advanced analytical methods.
• Mesenchymal stem cells (MSCs) serve as the active pharmaceutical ingredient – a viable alternative to steroidal and non-steroidal anti-inflammatory drugs.
• Through their immunomodulatory effect, MSCs induce natural pathways of intracellular signal transduction, having a strong anti-inflammatory, analgesic and pro-regenerative effect.
• MSCs are a long acting API, and their therapeutic effect is based on stimulating the natural processes of the body – they cause none of the adverse reactions associated with chronic anti-inflammatory drug use.
• The key property of stem cells used in therapy is their capacity to actively support the regeneration of damaged tissue.