Jul 08, 2021 Kelly Stanton

What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?

Did you know that the biopharmaceutical industry represents some of the most significant achievements in modern science and technology?

When you stop to take a look, you’ll see that the total volume of life sciences startups and scale-ups worldwide is staggering. From drug delivery and development to the treatment of rare diseases, life sciences organizations continue to solve the world’s most pressing medical challenges.

So what’s the difference between a biopharmaceutical startup vs. a pharmaceutical startup? 

For some, the answer is obvious. For others, it isn’t as clear.

In this article, we’ll break down the key differences between biopharmaceutical and pharmaceutical startups. Keep reading to better understand the unique similarities and differences between each product category.

The Difference Between Biopharmaceutical and Pharmaceutical Startups

The biopharmaceutical industry and pharmaceutical industry differ in several ways. The main difference comes down to product manufacturing.

Biopharmaceutical products are manufactured in living organisms, including white blood cells or bacteria. On the flip side, pharmaceutical products are manufactured using chemical-based processes.

Both of these product categories assist in the prevention and treatment of all communicable and non-communicable diseases, including infectious, genetic, and physiological diseases. All biopharmaceutical/pharmaceutical manufacturers must achieve rapid regulatory approval through all major governing bodies. 

Here’s a complete summary of some of the other key differences between biopharmaceutical and pharmaceutical startups.

Handling

Biopharmaceutical and pharmaceutical products share many of the same handling requirements. 

For example, both must be stored in temperature-controlled environments. Manufacturers must also ensure that storage facilities are thoroughly decontaminated.

However, there are significant differences in risk management protocols.

 Biopharmaceutical products are prone to microbial contamination. Those handling these delicate products must wear personal protective equipment, including goggles, lab coats, and face shields. Manufacturers must also activate microbial detection systems to limit contamination hazards.

Sterilization and Purification

There are major differences in the sterilization and purification methods biopharmaceutical and pharmaceutical manufacturers use. 

However, all biopharmaceutical and pharmaceutical products must follow a regimented purification process

In recent years, new innovations have changed the way manufacturers activate product purification. One of the most promising innovations is centered around the removal of reaction byproducts. 

Here’s some more background from Pharmaceutical Technology Europe Magazine

In processes that use a series of chemical reaction steps to synthesize the API, the removal of reaction byproducts, including color bodies and metals, is critical to produce high quality pharmaceuticals. The preferred methods for removing residual metal catalysts are distillation, crystallization, and precipitation.

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Costs

Today, economic and regulatory pressures place manufacturing burdens on both biopharmaceutical and pharmaceutical product developers. 

In recent years, increased manufacturing costs have forced manufacturers to reevaluate the effectiveness of both internal and external resources, including quality management systems.

Biopharmaceutical products tend to require longer production times. As a result, they experience higher manufacturing costs. 

Both product categories face strict regulatory criticism, which can also lead to increased costs related to quality assurance.

How to Build an Expert Quality Assurance Plan

Now that you have a better understanding of the key differences between biopharmaceutical and pharmaceutical startups, you need to make sure your company has an adequate quality assurance plan to streamline production, manufacturing, and distribution.

The most effective biopharmaceutical and pharmaceutical manufacturers use quality as a competitive advantage. 

To activate expert-level quality assurance within your own organization, we recommend downloading our free guide: The Perfect Quality Assurance Plan for Pharmaceutical Companies.

The guide provides a step-by-step process you can follow to build a quality assurance plan. We’ll even give you some great insider-intelligence that you can use to find the right quality management system for your growing life sciences company.

 

A quality management system provides immediate enhancements to most quality assurance plans. Over the years, we’ve helped thousands of growing life science startups and scale-ups navigate toward rapid system adoption, implementation, and activation — and we hope to help yours, too. 

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Published by Kelly Stanton July 8, 2021