Aerosolized Vaccine and Gene Therapy Testing and Development

Aerosol Vaccine and Gene Therapy Testing at ARE Labs

Aerosolized Vaccine and Gene Therapy Testing and Development

Aerosol Vaccine and Gene Therapy Testing at ARE Labs

Aerosolized Vaccine and Gene Therapy Testing and Development

Aerosol Vaccine and Gene Therapy Testing at ARE Labs

At the forefront of potential applications of aerosols to deliver medical treatments is the development of new vaccines and gene therapies. Administering gene therapies and vaccines via aerosols is an area of significant interest and development in medical science. This method, often referred to as pulmonary or inhalation delivery, offers a non-invasive and potentially efficient way to deliver treatments directly to the respiratory system. ARE Labs can assist in evaluating your vaccine or gene therapy treatment and delivery device to ensure proper deposition in the lungs and nasal mucosal regions.

At the forefront of potential applications of aerosols to deliver medical treatments is the development of new vaccines and gene therapies. Administering gene therapies and vaccines via aerosols is an area of significant interest and development in medical science. This method, often referred to as pulmonary or inhalation delivery, offers a non-invasive and potentially efficient way to deliver treatments directly to the respiratory system. ARE Labs can assist in evaluating your vaccine or gene therapy treatment and delivery device to ensure proper deposition in the lungs and nasal mucosal regions.

At the forefront of potential applications of aerosols to deliver medical treatments is the development of new vaccines and gene therapies. Administering gene therapies and vaccines via aerosols is an area of significant interest and development in medical science. This method, often referred to as pulmonary or inhalation delivery, offers a non-invasive and potentially efficient way to deliver treatments directly to the respiratory system. ARE Labs can assist in evaluating your vaccine or gene therapy treatment and delivery device to ensure proper deposition in the lungs and nasal mucosal regions.

Prospective Vaccines and Gene Therapies in Development

Prospective Vaccines and Gene Therapies in Development

Prospective Vaccines and Gene Therapies in Development

  • Cystic Fibrosis Gene Therapy: One of the most researched areas for aerosol gene therapy is in the treatment of cystic fibrosis. Researchers have been investigating the use of aerosolized vectors, like adenoviruses or adeno-associated viruses, to deliver a functional copy of the CFTR gene directly to the patient's lung cells.

  • Respiratory Syncytial Virus (RSV) Vaccine: Aerosol vaccines for RSV are being explored as a way to directly immunize the respiratory tract. This method could potentially provide more effective protection against respiratory viruses compared to traditional injections.

  • Tuberculosis (TB) Vaccine: Aerosolized forms of TB vaccines, such as modified BCG vaccines, are under investigation. Delivering the vaccine directly to the lungs may enhance the immune response against TB, which primarily affects the lungs.

  • COVID-19 Vaccines: With the global impact of COVID-19, there has been interest in developing aerosolized versions of COVID-19 vaccines to provide direct protection to the respiratory system, where the virus commonly enters and infects the body.

  • Influenza Vaccine: Aerosolized influenza vaccines, like FluMist, are already in use. This nasal spray vaccine is a form of live attenuated influenza vaccine (LAIV) and is designed to induce an immune response in the mucosal lining of the respiratory tract.

  • Gene Therapy for Lung Cancer: Experimental studies have explored the use of aerosolized gene therapy for lung cancer, where genes that can trigger cancer cell death or boost immune response against cancer cells are delivered directly to the lung tissue.

  • Aerosolized Vaccines for Allergic Asthma: There’s ongoing research into using aerosolized vaccines to modify the immune response in allergic asthma. The goal is to induce tolerance against common allergens by delivering modified allergen genes directly to the lungs.

  • Gene Therapy for Pulmonary Arterial Hypertension (PAH): Research includes the development of gene therapies targeting the lungs to treat PAH, a severe lung disease, through aerosol delivery of therapeutic genes.

It's important to note that while aerosol delivery of gene therapies and vaccines holds great promise due to its potential for targeted and efficient treatment, many of these therapies are still in the experimental or clinical trial stages. The effectiveness and safety of these methods continue to be key areas of research and development. ARE Labs can assist in the development and characterization of these emerging delivery methods.

Our Advanced Testing Capabilities

Our Advanced Testing Capabilities

Our Advanced Testing Capabilities

  • Particle Size Distribution Analysis: Using sophisticated methods, we measure the particle size distribution of aerosolized vaccines or gene therapy drugs as well as analyze the methods by which they are delivered including nebulizers, meter dose inhalers (MDI), dry powder inhalers (DPI) and others. This analysis is crucial for ensuring optimal drug deposition in the lungs and effective treatment or vaccine administration.

  • Droplet Aerosol Testing: We evaluate the particle size and distribution to understand the drugs performance in creating a breathable aerosol that can reach targeted areas in the respiratory tract as well as the efficacy of the delivery method itself.

  • Drug Delivery Efficiency: Our tests assess the efficiency of drug delivery, ensuring the precise amount of medication is delivered to the patient with minimal wastage.

  • Customized Testing Protocols: Tailoring our services to your specific needs, we develop customized testing protocols that align with industry standards and regulatory requirements.

Testing Services Offered

Testing Services Offered

Testing Services Offered

We offer a wide array of testing services to help ensure that your vaccine or gene therapy formulation as well as its’ intended delivery device is effective and compliant with regulatory requirements. Some of our testing services include:

  • Delivered Dose Testing: In order to deliver API to the lungs, the product must produce particles or droplets that are less than 5μm.  By measuring the drug particle size distribution, we are able to approximate how much drug is delivered and where it will be deposited in the lung.  Working to pharmacopeia methods we determine aerodynamic particle size distribution (APSD) by cascade impaction methods as well as laser diffraction measurements. We utilize two instruments that are commonly used to characterize the particle size distribution including the Anderson Cascade Impactor (ACI) and the Next Generation Impactor (NGI). The APSD is a critical quality attribute in the development and testing of inhaled and nasal products. Utilizing HPLC analysis we can determine the concentration of the API throughout the particle size distribution ensuring your device is producing particle sizes optimized for inhalation.

  • Laser Diffraction Particle Size Analysis: Particle size testing by laser diffraction provides a rapid screening tool and can provide valuable performance data which is particularly useful in early-stage formulation development. We utilize several different advanced laser diffraction instruments to characterize the native particle size distribution output of the drug formulation and the device which is meant to administer it. However, this method does not discriminate between multiple components in a formulation and so must be used alongside aerodynamic cascade impaction tests later in development. Laser diffraction produces results for Mass Median Aerodynamic particle size (MMAD), Geometric Standard Deviation (GSD) and overall particle size distribution. ARE Labs utilizes the latest laser diffraction technology such as Malvern Spraytec Laser Particle and Droplet Sizing as well as TSI Aerodynamic Particle Sizers. We also have the capabilities to measure nanoparticles (<500nm) using a TSI Fast Mobility Particle Sizer.

  • Spray Pattern/Plume Geometry: Spray pattern and plume geometry characterization during development is a regulatory requirement for drugs designed for respiratory delivery aimed at the US market (with many European developers also including this information in their submissions). Spray pattern data is also required for release testing. Spray pattern and plume geometry testing in this case for vaccine and gene therapies may only be needed if the intended delivery device was a nasal delivery device or meter dose inhaler. The shape, angle and duration of plume is highly influential in the uniform delivery and bioavailability of the product, and therefore product efficacy. For a meter dose inhaler, for example, the shape of the plume and how it disperses will affect where the drug product is deposited in the lungs or nasal regions and this in turn affects absorbance and bioavailability. Our scientists use automated actuation and analysis by instruments such as the Proveris SprayView which incorporates actuation and high-speed imaging to obtain accurate and robust data that enables you to calculate various parameters. 

Why Choose ARE Labs for Vaccine and Gene Therapy Aerosol Testing?

Why Choose ARE Labs for Vaccine and Gene Therapy Aerosol Testing?

Why Choose ARE Labs for Vaccine and Gene Therapy Aerosol Testing?

  • Industry Expertise: With years of experience in aerosol science, our team brings an in-depth understanding of respiratory drug delivery and the devices used to administer these drugs.

  • Cutting-Edge Technology: We employ the latest in aerosol testing equipment, ensuring precise and accurate results.

  • Regulatory Compliance: Our testing services are designed to help you navigate the regulatory landscape, ensuring your products comply with FDA, ISO, and other relevant standards.

  • Client-Centric Approach: We work closely with our clients, offering personalized service and expert guidance throughout the testing process.

Contact Us Today

To learn more about our vaccine and gene therapy aerosol testing services or to discuss your specific testing needs, contact us. Let ARE Labs be your partner in achieving excellence in respiratory treatment solutions.

Contact Us Today

To learn more about our vaccine and gene therapy aerosol testing services or to discuss your specific testing needs, contact us. Let ARE Labs be your partner in achieving excellence in respiratory treatment solutions.

Contact Us Today

To learn more about our vaccine and gene therapy aerosol testing services or to discuss your specific testing needs, contact us. Let ARE Labs be your partner in achieving excellence in respiratory treatment solutions.

At ARE Labs, we pride ourselves on adhering to the highest standards of regulatory compliance. All our testing services are conducted in strict accordance with FDA guidelines and cGLP (current Good Laboratory Practice) regulations, ensuring our clients receive results that are both reliable and recognized by regulatory bodies.

At ARE Labs, we pride ourselves on adhering to the highest standards of regulatory compliance. All our testing services are conducted in strict accordance with FDA guidelines and cGLP (current Good Laboratory Practice) regulations, ensuring our clients receive results that are both reliable and recognized by regulatory bodies.

At ARE Labs, we pride ourselves on adhering to the highest standards of regulatory compliance. All our testing services are conducted in strict accordance with FDA guidelines and cGLP (current Good Laboratory Practice) regulations, ensuring our clients receive results that are both reliable and recognized by regulatory bodies.