ourStudies

A split image of a woman with aging and youthful sides, encapsulating the science of anti-aging.
Jan 5, 2024

Staying Young

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Photorealistic image showing ADC molecules binding to a cancer cell, illustrating the precision of cell-based assays in cancer treatment
Nov 20, 2023

Revolutionizing Cancer Treatment: How Potency Assays Make ADCs More Effective

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Illustration of Potency Assay in Bispecific Antibodies for Cancer Treatment - Cell-Based Assay Expertise
Oct 24, 2023

Potency Assay for Bispecific Antibody Constructs

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Aug 6, 2023

Novel High Sensitivity Bispecific Antibody ELISA

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May 31, 2023

Implementing cGMP Potency Assays in PROTAC Drug Development

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May 22, 2023

Expanding the Toolbox of PROTAC Degraders with Covalent Ligands for Genetically Validated Targets

Explore the potential of Proteolysis Targeting Chimeric (PROTAC) drugs in therapeutic applications. Uncover how they use the ubiquitin-proteasome system to degrade specific harmful proteins.

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Apr 13, 2023

Expanding the Eligibility for AAV Gene Therapy with Monoclonal Antibodies

Gene therapy has emerged as a promising approach to treating rare genetic disorders and unmet medical needs. Adeno-associated virus (AAV)-based gene therapy is the leading platform for gene delivery; however, the natural prevalence of humoral immunity against AAV in humans limits the population of patients who can benefit from this therapy.

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Mar 11, 2023

Capsid engineering of adeno-associated virus (AAV) vectors

Invention: The researchers from Adverum Biotechnologies. (Redwood City, CA) have developed a method for generating eukaryotic cell libraries for screening mutant AAV capsid proteins.

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Feb 20, 2023

Single-dose immunogene therapy – A universal alternative for CAR-T cell therapy

Immunogene therapy is a combination of two different treatment methods: gene therapy and immunotherapy. In immunogene therapy, a protein/antibody, gene, or nucleic acid molecule is delivered to patients by gene therapy methods with the intention of inducing targeted immunomodulatory effects.

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Nov 7, 2022

Immunogenicity assays for adeno-associated virus (AAV)-based gene therapy

Immunogenicity assays are designed to determine the immune response to biotherapeutics such as protein, peptide, antibody, oligonucleotide or DNA/RNA-based drugs and its clinical impact.

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QUICK READS

From the beginning and ongoing, your assay is a critical component of the life cycle of your current or eventual product. That is precisely why you want experience and expertise at the earliest possible stage of your development.

In order to determine shelf life for a particular drug substance, stability tests are performed at pre-determined calendar intervals. Our project coordinators communicate closely with you to anticipate the arrival of samples so as to have our staff and resources available for timely analysis and submittal of data and Certificates of Testing.

Knowing the importance to the FDA of lot release potency testing, our scientific team tests every manufacturing lot with your assay providing Certificates of Testing in a timely manner, under GMP Condition.

Whether patient samples or drug product samples we will map out a timeline and follow through with sample receipts, meeting your regulatory needs at all points. We perform your assay as developed, qualified or validated, and promptly communicate the results and/or Certificate of Testing for any or all of your preclinical or clinical phases.

To validate an assay is to measure precision, linearity, accuracy, robustness, system suitability and repeatability. To achieve these results, we conduct multiple experiments in a pre-validation phase with the assay. This phase is a series of 2-4 experiments that specifically look at these capabilities. Once we have advanced an assay, we perform the assay 2 more times for a total of 3 identical repeats. At that point, your assay meets the FDA GLP or GMP requirements.

Many companies planning an IND submission or in Phase I/II may only require a well-qualified assay rather than a fully validated assay. You may or may not need GLP/GMP stringency and auditability yet. Our scientific team works with your scientists to qualify your assay for reproducibility, appropriate precision and accuracy.

We are firm believers in kits. The analytical portion of the assay itself is only a single component of what it takes to perform a successful experiment. It is all the other skills, experience and GLP/GMP conditions that we do day in and day out that will save you time getting to the results you actually want yesterday. We can create and distribute kits, too.

When you need an assay to prove your science and there is no commercial kit available, you need a custom assay. Our extensive expertise will quickly and methodically develop your assay to prepare it for eventual validation. Typically an assay can be developed from scratch in 5 or less experiments while minimizing any matrix effects.