Production Process
The main difference between pharmaceutical and biopharmaceutical products comes down to their manufacturing. Biopharmaceutical products are manufactured in living organisms and produced using biotechnology, whereas pharmaceutical products are manufactured using chemical-based processes in laboratories.
Some examples of biopharma products would be vaccines, gene therapies, antibodies and recombinant proteins like insulin. Biopharmaceutical products tend to be used for conditions where traditional pharmaceuticals are less effective such as in areas like oncology, autoimmune diseases and rare genetic disorders.
Pharmaceutical products, on the other hand, include painkillers, antihistamines and blood pressure medications and tend to dominate the market for most common conditions due to their wide-ranging applications.
Biological processes such as fermentation or cell culture are typically more complex as they require the growth and maintenance of living cells and are typically large, complex molecules. Pharmaceutical processes are generally more predictable and precisely controlled.
Handling
Handling requirements tend to be quite similar for biopharmaceutical vs pharmaceutical products. For example, both must be stored in temperature-controlled environments and storage facilities must be thoroughly decontaminated to ensure the quality and purity of the product.
However, biopharmaceutical products are prone to microbial contamination. This means that those who are handling these products must wear personal protective equipment (PPE) including lab coats, face shields and goggles. Manufacturers must also activate a microbial detection system to limit contamination hazards.
Regulation
Both pharmaceutical and biopharmaceutical products must be subject to rigorous testing and approval processes by regulatory bodies like the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency). For biopharma products, the approval process can be more complex due to the intricate biological processes involved with their production.
Costs
Is there a difference in cost for manufacturing biopharma vs pharma products? Yes! As biopharmaceutical products tend to take longer in production, they experience higher manufacturing costs than pharmaceutical products. However, both biopharma and pharma product developers face strict regulatory criticism which can also lead to increased costs related to quality assurance.
