Recorded Webinars

Adeno-associated viruses (AAV) can be engineered to deliver DNA to target cells. It is used extensively for the development of viral vector-based gene therapies in the pipeline. However, researchers encounter challenges with producing sufficient quantities of AAVs for gene therapy products, and they struggle to get delivery vehicles and their genetic payloads into the brain across the blood-brain barrier. 

In this panel discussion, Bernardo Cordovez, founder and chief science officer of Halo Labs, discusses such challenges and their mitigating factors with Nicole Faust, general manager of cell line development at Cytiva’s Cevec, Jacinthe Gingras, head of the discovery biology unit at Homology Medici

Aura+ is the latest instrument designed specifically to detect, count, and characterize subvisible aggregates and extrinsic materials for product quality measurements in both AAV and lentiviral gene therapy applications. Aura+ outputs images, count, size, particle identification and morphological information with 100% sampling efficiency requiring as little as five microliters of sample volume through Backgrounded Membrane Imaging and Fluorescence Membrane Microscopy (FMM). FMM identifies aggregates as cellular, protein, or extrinsic so you can quickly know what is in your sample. Specifically, Aura+ has the capability to detect SYBR® Gold stain, which is used to detect the presence of DNA in AAV or lentiviral aggregation to understand the role of leaky capsids in subvisible particle formation often leading to reduced AAV transduction efficiency and adverse patient responses. Aura+ can also use protein- or lipid-specific fluorescent stains to provide further insight into particle characterization.

In this GEN webinar, Dr. Bernardo Cordovez will discuss Aura® GT and how to characterize gene therapies for stability and CQAs using a minuscule amount of sample. With this novel platform, drug products and particles can be quantitated for size and count, imaged by microscopy for morphological features, and identified via labeled fluorescence by fluorescence membrane microscopy, using a fraction of the sample requirement compared to other methods. Dr. Cordovez will also discuss the technique of fluorescently labeling DNA payloads to understand its impact on subvisible aggregate formation for AAV product stability and shelf life. As a result, gene therapy developers finally have the cutting-edge tools required to develop advanced science and medicine.

Antibody-producing Chinese hamster ovary (CHO) cell lines have been long used to produce antibodies without aggregation in mind. Aura+® is the first instrument designed to characterize antibody stability as early as cell line development (CLD).

Polysorbates 20 and 80 are excipients used in >70% of marketed parenteral biological drugs to improve product stability and shelf life. However, unwanted visible and subvisible particles are formed when formulations containing these excipients are stored for long periods of time at low temperatures.

In this webinar, Dr. Bernardo Cordovez, will give us more insight into a novel platform technology that delivers low volume, high-throughput subvisible particle imaging counting, sizing, and identification.

In this talk, we overview the ability to perform subvisible particle analysis from cell line development through developability assessment, into product development and release as it is USP 1788 Method 2 compliant.

Presented in-person at the 3rd annual Cell Therapy Analytical Development Summit in Boston, MA, CSO and co-founder Bernardo Cordovez, Ph.D. discussed new tools required to fully characterize cell and gene therapies for product purity, stability, and viability across all stages of biologic development.

Presented live at Oxford Global’s Biotherapeutics US conference held in Boston, MA, Dr. Bernardo Cordovez presented how to identify protein aggregates and distinguish them from degraded polysorbate components, determine subvisible particle content of AAV formulations at low volumes under different stress conditions, and demonstrate thorough particle characterization of cellular therapy products including cell aggregation, viability, and product impurities.

Measuring cell viability is an incredibly important step across all applied cell biology, including cell line development for biotherapeutics and cell immunotherapy. However, traditional tools such as flow cytometry and hemocytometry struggle to differentiate between live cells and cell debris and other contaminants due to their workflows.

In this webinar, Dr. Bernardo Cordovez will show how high-throughput, backgrounded membrane imaging and fluorescence membrane microscopy enables the measurement of cell viability and foreign particle impurities quickly and accurately, in a single workflow. In addition, he details how these techniques can be used to find residual particulate contaminants such as expansion beads, cellular aggregates, and others in concentrated cell therapy solutions. Lastly, Dr. Cordovez will look at how these techniques can be deployed in cell line development of therapeutic proteins to identify protein and cell aggregation quickly and accurately.

Do you currently chug along check boxing regulatory mandates described by USP? If so, you may be putting patients, and your company, at risk. Simple and proper due diligence measures performed on drug products, such as identifying sub-visible particles and aggregates, would not only prevent product recalls but, more importantly, avert patient deaths—due to early detection before lot release.

In this GEN webinar, Halo Labs CSO and Co-founder Bernardo Cordovez, PhD, will help us understand the nature of sub-visible particles and if it is your drug product that is aggregating or some other potentially unsafe material. Moreover, Dr. Cordovez will tell us how to determine if the aggregates are intrinsic, inherent, or extrinsic. Finally, he will take us through numerous examples and scenarios where using the Aura™ systems can help organizations identify problems early in production streams so that drug products can be safely released, allowing patients and clinicians to focus more on the therapeutic value of the final material.

Years of research and innovation within the cell and gene therapy space are rapidly showing signs of success, as an ever-increasing list of therapeutics have either already been approved for clinical use or are set to burst on the scene. Biomanufacturers have developed cutting-edge processes to create these life-saving compounds. Still, safety is always a paramount concern, and companies are constantly looking for new ways to improve their product and pipelines. Subvisible particle contamination is the leading cause of drug product recalls and a critical quality attribute, and improved modalities to easily detect and identify these particles are crucial.

In some of the newest cell and gene therapies, the drug itself is subvisible in nature. So, how do you tell a good particle (like a cell) that should go into a patient from a harmful particle that should not? In this GEN webinar, we are going to hear about a new way to determine the good and the bad from our distinguished presenter Dr. Bernardo Cordovez. We will learn about case studies measuring stability and purity of CAR-T cell therapies and AAV gene therapy products using the Aura CL™—an instrument designed specifically to detect, count, size, and identify subvisible biological aggregates and extrinsic materials for product quality measurements in cell and gene therapy applications.

Polysorbates 20 and 80 are excipients used in >70% of marketed parenteral biological drugs to improve product stability and shelf life. However, when formulations containing these excipients are stored for long periods of time at low temperatures, visible and subvisible particles are formed. There exists a need to distinguish degraded polysorbate from other particle types but high-throughput, sensitive, and specific analysis of polysorbate particles has been difficult due to their complex chemistry, their low concentrations, and the fact that they appear like other particle types when using optical imaging techniques.

Halo Labs has solved this perennial needle in a haystack problem. Using the Aura™ polysorbate can be quickly identified and distinguished from other particle types. Using the Aura’s high throughput, low volume format, months of development time can be saved by knowing the source of particles in your formulation and distinguishing aggregated drug product from degraded excipients.

In this webinar, we present at the virtual Biomolecular Interaction Technologies Center (BITC) symposium demonstrating the expansive capabilities of the Aura platform. Many thanks to University of Delaware for the privilege to speak to an esteemed audience.

Introducing the Aura CL, the first subvisible particle detection platform specifically designed for cell and gene therapy applications. In as little as 5 µL, the Aura CL can quantify subvisible particles and ID them as cellular, protein, viral capsid, or extrinsic material in a matter of minutes. The Aura CL uses a direct and specific fluorescent labeling approach so there is no need to rely on inaccurate morphological characteristics. Based on USP 788, the Aura CL is easy to validate and incorporate into all particle testing workflows.

Introducing the Aura CL, the first subvisible particle detection platform specifically designed for cell and gene therapy applications. In as little as 5 µL, the Aura CL can quantify subvisible particles and ID them as cellular, protein, viral capsid, or extrinsic material in a matter of minutes. The Aura CL uses a direct and specific fluorescent labeling approach so there is no need to rely on inaccurate morphological characteristics. Based on USP 788, the Aura CL is easy to validate and incorporate into all particle testing workflows.

In this webinar, we introduce the Aura system, a 96-well low-volume aggregate and particle imaging system that can rapidly size, count, and characterize particles and identify them as proteins, non-proteins, hydrophobic, or other types of molecules. Learn how to characterize aggregates that are not detected by other methods, identify the source of particles to develop the right mitigation approaches, classify particles as inherent, intrinsic, or extrinsic, characterize critical quality attributes early in development, and use a USP compendial method to characterize stability throughout development

Learn how the Aura system can be a complete tool for your lab’s stability testing and quality control measurements. With the ability to quantify aggregates and particles, identify them as inherent, intrinsic, or extrinsic, and perform analysis with any volume you choose, Aura offers continuity of method like no other instrument can. Perform early stage analysis with very little volume and use the same instrument to perform large volume particle counts in your entire container.

In this webinar we explore early-phase development strategies, covering both fundamentals (successful approaches such as platforms) and specialized considerations (what to consider when faced with novel constructs).

The Aura™ system, with its ability to count, size, and ID particles, is a powerful tool for biologics and gene therapy. It can be used for early stage aggregate analysis in developability and formulations as well as late stage subvisible particle analysis in QC and lot release. In this webinar, you will learn how Aura is easy to validate for counting and sizing with it’s powerful software and 100% sample imaging, making Aura a perfect fit for those seeking a continuous method.

In this webinar, we introduce Aura^™, a 96-well low-volume aggregate and particle imaging system that can rapidly size, count, and characterize particles and identify them as proteins, non-proteins, hydrophobic, or other types of molecules.

In this webinar, we introduce Aura^™, a 96-well low-volume aggregate and particle imaging system that can rapidly size, count, and characterize particles and identify them as proteins, non-proteins, hydrophobic, or other types of molecules.

In this webinar, we introduce Backgrounded Membrane Imaging (BMI), a fully automated form of USP <788> membrane microscopy available on the Horizon^® instrument from Halo Labs. BMI utilizes disposable 96-well membrane plates and automated image processing to rapidly generate accurate particle counts and sizing in low volume, high throughput format. With BMI, subvisible aggregate analysis can be incorporated at any stage of biologic development – from candidate selection to formulation screening, process development, and analytical – providing key insights that reduce drug development risk and time to market.

This seminar introduces automated Backgrounded Membrane Imaging (BMI) as a solution for detecting and quantifying subvisible AAV aggregates in low volume, high throughput format. BMI is fully automated, fluidics-free, and uses only 25 μL per sample. Learn how BMI’s high-resolution images and comprehensive data analysis can reveal particle issues that may be missed by other methods like DLS and SEC – providing a more complete picture of your viral vector stability

Subvisible particle analysis is a key predictor of protein drug stability and an essential drug product quality metric. However, current subvisible methods require large volumes of precious samples and are labor- and time-intensive, making it challenging to obtain this vital information during late-stage candidate screening and early development — especially with high concentration protein formulations. The Horizon^® system from Halo Labs is the industry’s first analytical system to address the need for rapid, comprehensive subvisible particle analysis even when limited sample material is available.

In this webinar, you will learn how about Backgrounded Membrane Imaging (BMI) on the HORIZON system can accelerate discovery and early ADME workflows as an easy and sensitive method for compound solubility measurement. In addition, highly resolved images and shape distribution data provide valuable information on morphology of precipitated solids for more comprehensive solubility characterization.

In this webinar, Fujifilm Diosynth Biotechnologies presents comparative analytical data spanning across several different research programs and also  present a more detailed story about a particular monoclonal antibody for which they have recently completed accelerated and real-time stability studies.