Are Biologics Made from Stem Cells?

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Biologics have transformed the treatment of many severe and life-threatening diseases. But where do these complex medicines come from? Are they made using stem cells? This article will provide a comprehensive overview of what biologics are, how they are made, and the role stem cells play in their production.

What Are Biologics?

Complex Medicines from Living Sources

Biologics, also known as biologic drugs or biopharmaceuticals, are medicines made from living organisms instead of chemicals. They contain proteins, sugars, nucleic acids, or complex combinations of these substances derived from biological sources like cells and tissues.

Unlike conventional drugs made from chemicals, biologics are more structurally complex. They are often 100-1000 times larger than traditional medicines and cannot be easily identified or characterized.

Used to Treat Serious Diseases

Biologics are most commonly used to treat debilitating autoimmune disorders, cancers, and other serious medical conditions when other medications are ineffective or unsuitable.

Some examples of diseases treated with biologics include rheumatoid arthritis, psoriasis, Crohn’s disease, cancers, multiple sclerosis, and diabetes.

Manufacturing Process Involves Living Cells

The manufacturing process of biologics is complex and involves using living cells or organisms as “factories” to produce the desired therapeutic substances. Bacteria, yeast, and mammalian tissue and cells are commonly used in biologics production.

The living cells are genetically engineered to produce the required proteins or molecules that become the active ingredients of the biologic drug.

Regulatory Oversight Due to Complexity

Due to their complexity and use of living systems for manufacturing, biologics are more tightly regulated than chemical drugs. In the US, the FDA has a separate approval process and manufacturing quality standards for biologics.

How Are Biologics Made?

Overview of Manufacturing Process

The process of making biologics can be divided into two main steps:

  1. Development of Cell Line: Cells are genetically engineered to produce the desired therapeutic protein or molecule.
  2. Cell Culture: The engineered cells are cultured in conditions that maximize growth and production. The therapeutic substance is then harvested and purified.

Let’s look at these steps in more detail:

Cell Line Development

The first step is to engineer cells that can produce the therapeutic ingredient. Different types of cells used include:

  • Bacteria – Often E. coli; advantages include fast growth and well-understood genetics.
  • Yeast – Species like Saccharomyces cerevisiae; can produce proteins that require post-translational modifications.
  • Mammalian cells – CHO, NS0, and HEK 293 cells commonly used; can produce complex glycosylated proteins.

The selected cells are genetically modified to produce the desired substance. This could involve introducing a new gene or modifying an existing gene.

Multiple rounds of selection are done to isolate high-producing cell strains. This can take months to years of work.

Cell Culture

Next, the engineered cells are cultured in large bioreactors that provide optimized growing conditions. Nutrients, growth factors, and other cell culture parameters are carefully controlled.

As the cells grow and multiply, they produce the target therapeutic protein or molecule. This is then harvested from the culture and extensively purified.

The purified substance is formulated into the final medication. Fillers, stabilizers, and other ingredients may be added.

Do Stem Cells Play a Role in Making Biologics?

Stem cells are versatile cells that can both self-renew and turn into specialized cell types. Their ability to become different cell types makes them useful for regenerative medicine.

Stem Cells Can Be Classified as Biologics

Stem cells themselves can be considered a type of biologic. Stem cell therapies often involve injecting living stem cells from sources like bone marrow, cord blood, or fat tissue.

The infused stem cells secrete therapeutic substances and can also replace damaged cells. Stem cell transplants to treat blood cancers are a common example.

Role in Biologics Manufacturing is Limited

While stem cells have therapeutic uses, their actual role in manufacturing most biologic drugs is currently limited.

Other well-established and optimized cell lines like CHO, E. coli and yeast cells are predominantly used to produce complex therapeutic proteins and other molecules.

Using stem cells to produce biologics is still an emerging field. Challenges exist in reliably engineering them to produce biologics at scale.

Potential Future Uses of Stem Cells

While stem cells are not yet a major part of biologics manufacturing, there is excitement about their future potential applications.

Customized Biologics

One promising use is to develop personalized biologics tailored to a patient’s specific disease using their own stem cells. This could help overcome challenges some patients have with immunogenicity.

Researchers have had success engineering induced pluripotent stem (iPS) cells derived from a patient’s skin or blood cells to produce biologics.

Gene and Cell Therapies

Stem cells could enable new types of biologics beyond proteins, like gene and cell therapies. For example, using stem cells to deliver gene therapy vectors or as a source for engineered CAR T-cell therapies for cancer.

Streamlined Manufacturing

Stem cell capabilities like proliferation and plasticity could enable innovative bioprocessing methods that increase biologics production speed, yields, and quality control compared to current cell lines.

While promising, these applications will require continued research and technological advances to become commercially viable manufacturing platforms.


In summary, while biologics are made from living cells, stem cells currently play a limited role in their manufacturing. Instead, cell lines like CHO and E. coli are predominantly used due to their optimized properties for biologics production.

However, stem cells have exciting potential future applications in developing personalized biologics, new modalities like cell and gene therapies, and innovative biomanufacturing methods. Realizing these promising uses will require resolving both scientific and engineering challenges. But harnessing the power of stem cells could unlock new horizons in treating diseases with biologics.

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