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By QPS / September 12, 2023

The Ultimate Guide to Gene Therapy

What is Gene Therapy

Gene therapy, or genetic therapeutics, is a broad term, one that encompasses a range of therapeutic strategies. What is gene therapy? The term refers to therapies aimed at treating or curing certain diseases or conditions by targeting a person’s DNA. Gene therapy attempts to modify or manipulate the expression of certain genes or to alter the biological properties of living cells. It’s a promising treatment option for genetic or inherited conditions, such as cystic fibrosis and sickle cell disease, but its potential extends far beyond genetic conditions. Gene therapy may help treat or cure a range of conditions, from cancer to cystic fibrosis and diabetes to heart disease, AIDS, and more.

The purpose of gene therapy is to (1) rectify or replace faulty genes that cause certain diseases, (2) turn off mutating genes to prevent them from causing disease, or turn on healthy genes so that they can inhibit disease, and (3) train the body’s immune system to better recognize and attack diseased cells to fight illness or infection. As the field continues to develop, more gene therapies may be used to prevent, treat, or cure disorders that were previously considered incurable.

genetic

Benefits of Gene Therapy

With the rapid pace of technological progress and research breakthroughs, we’re only just beginning to understand the curative possibilities and benefits of gene therapy. Current known benefits include all of the following:

  • The potential to treat inherited conditions
  • Positive effects that can, in some cases, be passed down through generations
  • Solutions that are targeted and long-lasting
  • Treating or preventing a range of diseases or conditions previously considered incurable

To learn more, view Benefits of Gene Therapy.

Graphic-illlustration-depicting-DNA-strand-1024x683

What Diseases or Conditions Can Gene Therapy Treat?

Gene therapy holds great promise for the treatment of a wide range of diseases and conditions. Most gene therapies are still in the early stages of research, testing, and development. However, a number of gene therapies have been approved for use by the Food and Drug Administration (FDA), including spinal muscular atrophy, hemophilia A, leukemia, lymphoma, inherited retinal disorder, cerebral adrenoleukodystrophy (CALD), and Duchenne muscular dystrophy (DMD).

To learn more, view What Diseases or Conditions Can Gene Therapy Treat?

Graphic-DNA-strand

Types of Gene Therapy

Graphic DNA strand on multicolor background

Types of gene therapy vary depending on the specific disease and therapeutic goal. Gene therapy methods can be divided into two main categories: gene transfer therapy and genome editing. Broadly speaking, gene transfer therapy involves the introduction of new genetic materials into cells, whereas genome editing employs gene-editing tools in order to add, modify, or remove genetic material within cells.

Some of the most common types of gene transfer therapy or genome editing tools either in use or being studied today include the following:

  • Using modified viruses to deliver functional copies of missing or defective genes
  • Using oncolytic viruses (OVs) to selectively infect and kill cancer cells
  • Treating gene defects or inherited disorders with large RNA therapeutics
  • Coding small interfering RNAs (siRNAs) to target and silence the expression of specific genes or disease-causing RNA molecules
  • Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) editing
  • Chimeric Antigen Receptor T-cell (CAR-T) therapy

To learn more, view Types of Gene Therapy.

The History of Gene Therapy

The history of gene therapy is a journey of scientific breakthroughs, setbacks, and milestones. Although the concept emerged in the 1960s, scientists didn’t see significant technological progress for the first 20 or so years.

Real breakthroughs in recombinant DNA technology began to occur in earnest in the early 1980s, beginning with the publication of a paper that demonstrated, for the first time, that it was possible to use a virus as a mechanism for inserting genes into stem cells. In the 2010s, scientists improved the safety and effectiveness of viral vectors used to deliver gene therapies. And today, the FDA, led by Peter Marks, aims to expedite the approval of more gene therapies through regulatory flexibility, international collaboration, and accelerated approvals. Marks envisions a two to three-year transformation for life-saving gene therapies, potentially revolutionizing the bio-economy.

To learn more, view The History of Gene Therapy

Gloved-hand-using-tweezers-to-pull-out-a-section-of-DNA

In Vivo vs. Ex Vivo Gene Therapy

Graphic illustration of DNA strand

Ongoing developments in gene therapy continue to demonstrate its potential to transform the global healthcare system. Gene therapies may be the key to unlocking treatments and cures not only for a range of inherited genetic conditions but also for cancers, infections, and other serious illnesses. There are two methods by which gene therapy can be administered: in vivo and ex vivo. Are there specific advantages to in vivo vs. ex vivo gene therapy?

At the simplest level, the difference between the two can be understood as such:

  • With in vivo gene therapy, new or therapeutic genes are introduced or injected directly into the body.
  • With ex vivo gene therapy, cells are modified or treated in a lab before being returned to the body.

To learn more, view In Vivo vs. Ex Vivo Gene Therapy.

Our Work with Gene Therapy

QPS excels in advancing cell and gene therapy research with precision technology, custom-built quantitation methods, and proven oligonucleotide quantitation. We have supported gene therapy development since 2002 and can use that experience to help you navigate PK, immunogenicity, biodistribution, viral clearance, and ADME of these novel molecules in this rapidly expanding field. QPS scientists are ready to work with you to determine specific study parameters and provide complete, fully compliant data packages and reports, ready for submission.

Regulatory Considerations In Gene And Cellular Therapy Development
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Therapeutic RNAs: Past, Present, and Future
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Runners in a marathon, cropped to show shoulders down

Got a Case of “Marathon Brain?” Research Explains Why

Running 26.2 miles may not be everyone’s idea of a good time — but…
Young woman talking on phone while sitting on couch

Less Sitting, More Living: How Activity Reduces Risk for Heart Attack Survivors

Sitting down might seem harmless, but for heart attack survivors, prolonged sedentary time could…
Blue eye

Sight Concerns: Investigating the Link Between GLP-1 RA Medications and Eye Health

Glucagon-like peptide (GLP-1) receptor agonists (GLP-1 RAs) are transformative medications for millions of people…
Model of human brain surrounded by pills on yellow background

Non-Opioid Painkiller Blocks Pain at Its Source

Synthetic and semi-synthetic opioids offer powerful pain relief. Unfortunately, these drugs are also associated…
Pregnant woman holding ultrasound photo

Injecting Hope: Early Steps Toward Prenatal Treatment for Genetic Disorders

The potential to treat severe genetic disorders before birth has taken a promising step…
Digital illustration of human brain, one section highlighted pink indicating tumor

Unanswered Questions: Mysterious Cluster of Brain Tumors Investigated at Massachusetts Hospital

Six nurses working on the fifth-floor maternity unit at Newton-Wellesley Hospital in Massachusetts have…
Cow resting in field

Creutzfeldt-Jakob Disease Outbreak Sparks Concern

Prion diseases are rapidly progressive, neurodegenerative disorders caused by infectious protein particles called prions….
Pile of pills on blue background

A Double-Edged Cure: Antibiotics Linked to Childhood Asthma and Allergies

Antibiotics, revered as critical defenders against bacterial infections, might harbor an unexpected threat, particularly…
Woman putting chewing gum in her mouth

Chew on This: How Chewing Gum Could Fight the Flu

Cold and flu medicine likely isn’t your idea of a tasty treat. But what…
cat with rabies

Silent Infection: The Rare Risk of Rabies Transmission from Organ Transplantation

A routine kidney transplant took a tragic turn when a Michigan resident died as…
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Drug Development

Runners in a marathon, cropped to show shoulders down

Got a Case of “Marathon Brain?” Research Explains Why

Running 26.2 miles may not be everyone’s idea of a good time — but…
Young woman talking on phone while sitting on couch

Less Sitting, More Living: How Activity Reduces Risk for Heart Attack Survivors

Sitting down might seem harmless, but for heart attack survivors, prolonged sedentary time could…
Blue eye

Sight Concerns: Investigating the Link Between GLP-1 RA Medications and Eye Health

Glucagon-like peptide (GLP-1) receptor agonists (GLP-1 RAs) are transformative medications for millions of people…
Model of human brain surrounded by pills on yellow background

Non-Opioid Painkiller Blocks Pain at Its Source

Synthetic and semi-synthetic opioids offer powerful pain relief. Unfortunately, these drugs are also associated…
Pregnant woman holding ultrasound photo

Injecting Hope: Early Steps Toward Prenatal Treatment for Genetic Disorders

The potential to treat severe genetic disorders before birth has taken a promising step…
Digital illustration of human brain, one section highlighted pink indicating tumor

Unanswered Questions: Mysterious Cluster of Brain Tumors Investigated at Massachusetts Hospital

Six nurses working on the fifth-floor maternity unit at Newton-Wellesley Hospital in Massachusetts have…
Cow resting in field

Creutzfeldt-Jakob Disease Outbreak Sparks Concern

Prion diseases are rapidly progressive, neurodegenerative disorders caused by infectious protein particles called prions….
Pile of pills on blue background

A Double-Edged Cure: Antibiotics Linked to Childhood Asthma and Allergies

Antibiotics, revered as critical defenders against bacterial infections, might harbor an unexpected threat, particularly…
Woman putting chewing gum in her mouth

Chew on This: How Chewing Gum Could Fight the Flu

Cold and flu medicine likely isn’t your idea of a tasty treat. But what…
cat with rabies

Silent Infection: The Rare Risk of Rabies Transmission from Organ Transplantation

A routine kidney transplant took a tragic turn when a Michigan resident died as…
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Gene Mapping

Runners in a marathon, cropped to show shoulders down

Got a Case of “Marathon Brain?” Research Explains Why

Running 26.2 miles may not be everyone’s idea of a good time — but…
Young woman talking on phone while sitting on couch

Less Sitting, More Living: How Activity Reduces Risk for Heart Attack Survivors

Sitting down might seem harmless, but for heart attack survivors, prolonged sedentary time could…
Blue eye

Sight Concerns: Investigating the Link Between GLP-1 RA Medications and Eye Health

Glucagon-like peptide (GLP-1) receptor agonists (GLP-1 RAs) are transformative medications for millions of people…
Model of human brain surrounded by pills on yellow background

Non-Opioid Painkiller Blocks Pain at Its Source

Synthetic and semi-synthetic opioids offer powerful pain relief. Unfortunately, these drugs are also associated…
Pregnant woman holding ultrasound photo

Injecting Hope: Early Steps Toward Prenatal Treatment for Genetic Disorders

The potential to treat severe genetic disorders before birth has taken a promising step…
Digital illustration of human brain, one section highlighted pink indicating tumor

Unanswered Questions: Mysterious Cluster of Brain Tumors Investigated at Massachusetts Hospital

Six nurses working on the fifth-floor maternity unit at Newton-Wellesley Hospital in Massachusetts have…
Cow resting in field

Creutzfeldt-Jakob Disease Outbreak Sparks Concern

Prion diseases are rapidly progressive, neurodegenerative disorders caused by infectious protein particles called prions….
Pile of pills on blue background

A Double-Edged Cure: Antibiotics Linked to Childhood Asthma and Allergies

Antibiotics, revered as critical defenders against bacterial infections, might harbor an unexpected threat, particularly…
Woman putting chewing gum in her mouth

Chew on This: How Chewing Gum Could Fight the Flu

Cold and flu medicine likely isn’t your idea of a tasty treat. But what…
cat with rabies

Silent Infection: The Rare Risk of Rabies Transmission from Organ Transplantation

A routine kidney transplant took a tragic turn when a Michigan resident died as…
Load More

Obesity

Runners in a marathon, cropped to show shoulders down

Got a Case of “Marathon Brain?” Research Explains Why

Running 26.2 miles may not be everyone’s idea of a good time — but…
Blue eye

Sight Concerns: Investigating the Link Between GLP-1 RA Medications and Eye Health

Glucagon-like peptide (GLP-1) receptor agonists (GLP-1 RAs) are transformative medications for millions of people…
close-up of vial and syringe on blue background

Pharma Strikes Back at Compounding Pharmacies

Skim the pharma news outlet of your choice, and it’s clear that compounding pharmacies…
close-up of an eye

Eyeing Potential Risks: Investigating Vision Changes Linked to GLP-1 Drugs

Millions of people take glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide and tirzepatide to…
Small bat resting on a human hand

Tiny Treadmills: Vampire Bats on the Go

In most mammals, the act of running is fueled primarily by the oxidization of…
Digital illustration of human liver

Rezdiffra Gains Approval, Marks a New Chapter in Treating NASH (MASH) with Liver Scarring

The US Food and Drug Administration (FDA) has approved Rezdiffra™ (resmetirom), the first medication…
Three vials and a syringe

Weight Loss Drug Prescriptions Become More Accessible With Single-Dose Option

Eli Lilly has launched a new way for patients to access its popular weight…
Pharmacist assisting senior man with medication

Sizing Up Potential Medicare Costs of Covering Weight Loss Drugs for Heart Health

Medicare may soon face steeply increased prescription drug costs as it considers covering the…
Turkeys in the snow

Going Cold Turkey — How a Week-Long Fast Affects Your Health

Advocates of fasting point to the potential health and longevity benefits, often citing results…
Needle beneath red no symbol

Weight Loss Rebounding: The Challenges of Stopping Obesity Drugs

Semaglutide, under the brand names Wegovy® and Ozempic®, has surged in popularity for its…
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Viruses

Runners in a marathon, cropped to show shoulders down

Got a Case of “Marathon Brain?” Research Explains Why

Running 26.2 miles may not be everyone’s idea of a good time — but…
Young woman talking on phone while sitting on couch

Less Sitting, More Living: How Activity Reduces Risk for Heart Attack Survivors

Sitting down might seem harmless, but for heart attack survivors, prolonged sedentary time could…
Blue eye

Sight Concerns: Investigating the Link Between GLP-1 RA Medications and Eye Health

Glucagon-like peptide (GLP-1) receptor agonists (GLP-1 RAs) are transformative medications for millions of people…
Model of human brain surrounded by pills on yellow background

Non-Opioid Painkiller Blocks Pain at Its Source

Synthetic and semi-synthetic opioids offer powerful pain relief. Unfortunately, these drugs are also associated…
Pregnant woman holding ultrasound photo

Injecting Hope: Early Steps Toward Prenatal Treatment for Genetic Disorders

The potential to treat severe genetic disorders before birth has taken a promising step…
Digital illustration of human brain, one section highlighted pink indicating tumor

Unanswered Questions: Mysterious Cluster of Brain Tumors Investigated at Massachusetts Hospital

Six nurses working on the fifth-floor maternity unit at Newton-Wellesley Hospital in Massachusetts have…
Cow resting in field

Creutzfeldt-Jakob Disease Outbreak Sparks Concern

Prion diseases are rapidly progressive, neurodegenerative disorders caused by infectious protein particles called prions….
Pile of pills on blue background

A Double-Edged Cure: Antibiotics Linked to Childhood Asthma and Allergies

Antibiotics, revered as critical defenders against bacterial infections, might harbor an unexpected threat, particularly…
Woman putting chewing gum in her mouth

Chew on This: How Chewing Gum Could Fight the Flu

Cold and flu medicine likely isn’t your idea of a tasty treat. But what…
cat with rabies

Silent Infection: The Rare Risk of Rabies Transmission from Organ Transplantation

A routine kidney transplant took a tragic turn when a Michigan resident died as…
Load More
← Previous Guide

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