Pharmaceutical vs Biopharmaceutical: What's the Difference?

Both pharmaceutical and biopharmaceutical drugs play crucial roles in the prevention and treatment of diseases in modern medicine. Although the two terms are often used interchangeably, they refer to two very different types of drug development and production.

In this blog, we will unpack the key differences between pharma and biopharma products ranging from the differences in their handling to the differences in their regulation and costs. 

 

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.