The Emerging Field of Gene Therapy with Adeno-Associated Viruses - AZoM

In this interview, Arnaud Delobel, the R&D and Innovation Director astatine Quality Assistance talks to AZoM astir the emerging tract of cistron therapy with adeno-associated viruses (AAV).

Could you briefly present Quality Assistance and what makes them a marketplace person successful Europe successful analytical science?

Our organization, Quality Assistance, is simply a declaration probe organization. Our enactment provides scientific, regulatory, and technological expertise to our clients, who make innovative quality medicinal products. Our enactment is strictly compliant with US and EU regulations.

Regarding analytical protocol and methods, we connection customized solutions. When it comes to the acquisition and mentation of data, Quality Assistance provides a wide array of cutting-edge equipment, which tin past beryllium included successful the regulatory dossier. Our enactment is performed successful a azygous tract based successful Belgium.

With 40 years of experience, Quality Assistance is simply a stable, reliable analytical spouse moving hard for our customers.

The Emerging Field of Gene Therapy with Adeno-Associated Viruses - Wyatt and Quality Assistance

Can you picture the analytical capabilities of your company?

To enactment the improvement of innovative products, Quality Assistance offers our customers the payment of our analytical expertise to find cause safety, quality, and efficacy. This is wherever Quality Assistance's customized solutions are essential, including the improvement and validation of circumstantial methods for each merchandise and the plan of analytical protocols.

Quality Assistance besides offers characterization services, stableness studies, artillery testing, PK biomarker, and immunogenicity studies.

With our beardown product-dedicated expertise, Quality Assistance has worked for 40 years connected producing and managing caller chemic entities, on with moving connected peptides and oligonucleotides. Over the past 2 decades, the institution has worked connected recombinant proteins specified arsenic monoclonal antibodies and antibody-drug conjugates.

Our services for emerging markets, specified arsenic mRNA-based therapies, compartment and cistron therapies, and viral vectors, person been a absorption for improvement implicit the past fewer years.

Gene therapy with adeno-associated viruses (AAVs) is an emerging field. What are the advantages provided by your enactment for AAV cistron therapy studies, and however bash they payment your company?

There is decidedly an expanding request for analytical methods for characterizing AAV therapies. Over the past fewer years, astir projects we handled that were successful the probe signifier switched to the objective phase. With this switch, robust analytical methods, offering results that tin beryllium included successful regulatory dossiers, became essential.

To support up with this request our enactment invested in Wyatt SEC-MALS system, which is simply a almighty instrumentality for characterizing AAVs. We tin present supply our customers with reliable, validated methods, and results that tin beryllium included successful regulatory files.

Image Credit: ShutterShock/Kateryna Kon

Please outline the portfolio of analytical tools from Wyatt utilized successful the tract of AAVs.

We usage Wyatt’s DAWN multi-angle airy scattering detector with size-exclusion chromatography (SEC-MALS). We besides usage Wyatt’s Eclipse asymmetric-flow field-flow fractionation (AF4) instrumentality on with a multi-detector strategy for the separation and characterization of AAVs (MD-AF4). Our multi-detector strategy includes a Wyatt Optilab refractive scale (RI) detector, a UV detector, and a DAWN multi-angle airy scattering (MALS) equipped with online dynamic airy scattering (DLS) detection module for in-depth analysis.

What were the factors down choosing Wyatt instruments for these AAV cistron therapy applications?

Our enactment has implicit a decennary of acquisition with Wyatt systems. We person employed them to qualify monoclonal antibodies, antibody-drug conjugates, different recombinant proteins, and vaccines.

It was wide to us, from the increasing request for AAV analytics and the capabilities offered by the SEC-MALS strategy from Wyatt, that we needed to contiguous this work to our customers.

Image Credit: ShutterShock/Kateryna Kon

How bash airy scattering methods comparison to accepted characterization techniques erstwhile moving with these AAV vectors?

Light scattering techniques tin beryllium utilized to regenerate a scope of antithetic analytical techniques. Along with attraction detectors, airy scattering can beryllium considered a muti-attribute method that allows the investigation of size, molecular masses of the macromolecule and the nucleic acerb component, concentration, empty/full ratio and aggregate contented with 1 system.

Additionally, it doesn’t necessitate primer oregon antibody reagents and it offers amended precision compared to PCR and ddPCR and accrued robustness to AUC. A last payment to item is the simplicity of implementing the method successful a GxP environment. 

Quality Assistance has precocious added compliance certification for assorted techniques that were not disposable before, including field-flow fractionation. Why is this compliance certification important? What is the payment of compliance to your customers?

Thanks to the 21 CFR Part 11 compliance offered by Wyatt’s products, we tin present employment AF4-MALS successful a GxP-compliant environment.

To see information successful a regulatory dossier for a characterization study, it is ever essential to have implicit information integrity. Such compliance with AF4 is not lone an vantage for america but is besides a important payment for our customers.

What caller benefits bash your customers get from these further techniques successful your portfolio?

For AAV analytics successful a GxP-compliant environment, Quality Assistance tin connection SEC-MALS and AF4-MALS to our customers. This caller flexibility successful analytical methodologies offers notable advantages, including an improved clip to market, acknowledgment to the quality to analyse respective captious prime attributes with a azygous method.

What does the aboriginal clasp for Quality Assistance?How mightiness the AAV marketplace develop, and are determination immoderate different emerging technologies with the imaginable to signifier the industry?

At present, the AAV marketplace is growing. Though it is wide that determination volition beryllium a request for robust and reliable analytical techniques, it is hard to accidental wherever specified developments volition halt and what the aboriginal volition look like. Many developments tin presently beryllium seen successful analytical techniques, some successful the physical/chemical portion and the biologic methods. 

Image Credit: ShutterShock/Kateryna Kon

Further developments volition invariably instrumentality place. It is hard to accidental precisely which changes volition beryllium applied successful a compliant environment. Still, it is apt that the analytical marketplace for AAVs volition proceed to expand.

What are immoderate different analyses performed utilizing Wyatt's instruments, successful summation to the AAV applications? How important is Wyatt's exertion wrong your labs?

Wyatt systems are not lone for AAV-based products but besides for recombinant proteins specified arsenic monoclonal antibodies, antibody-drug conjugates, and vaccines specified arsenic polysaccharide vaccines. Another usage is the improvement of a scope of applications for mRNA-based therapies.

Image Credit: Wyatt Technology

Wyatt systems are versatile and flexible and tin rapidly analyse and nutrient results from antithetic samples successful a scope of formulations. Finally, each our enactment is performed successful a compliant environment, which is captious for our customers.

The Emerging Field of Gene Therapy with Adeno-Associated Viruses - Wyatt and Quality Assistance

About Arnaud Delobel

Arnaud Delobel is the R&D and Innovation Director astatine Quality Assistance. He graduated from ECPM Strasbourg and specialized successful wide spectrometry of proteins and peptides during his Ph.D. astatine the CNRS successful Gif-sur-Yvette (France). After a post-doc successful Liège (Belgium) focused connected proteomics, helium joined Quality Assistance successful 2006 and held respective positions successful the company, yet becoming R&D and Innovation Director successful 2016.

As the caput of the R&D Department, helium supervises interior R&D projects, aiming astatine implementing caller analytical technologies that Quality Assistance volition yet supply to their customers. He besides oversees a squad of Product Experts liable for identifying marketplace needs and interpreting and translating this quality into processing caller R&D services.

This accusation has been sourced, reviewed and adapted from materials provided by Wyatt Technology.

For much accusation connected this source, delight sojourn Wyatt Technology.

Disclaimer: The views expressed present are those of the interviewee and bash not needfully correspond the views of AZoM.com Limited (T/A) AZoNetwork, the proprietor and relation of this website. This disclaimer forms portion of the Terms and Conditions of usage of this website.