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Protocol

Cartilage Assessment Requires a Surface Characterization Protocol: Roughness, Friction, and Function

The surface of articular cartilage is integral to smooth, low-friction joint articulation. However, the majority of cartilage literature rarely includes measurements of surface characteristics and function. This may, in part, be due to a shortage of or unfamiliarity with fast, nondestructive, and, p... More


Protocol

Optimized Protocol for Accurate Titration of Adeno-Associated Virus Vectors

Adeno-associated virus (AAV) is currently the most popular gene delivery vector for in vivo gene therapy. However, variability in titration methods between different laboratories affects the reproducibility of experiments and evaluation of safety and efficacy in clinical trials. We describe an optim... More


Protocol

Single-Use Capture Purification of Adeno-Associated Viral Gene Transfer Vectors by Membrane-Based Steric Exclusion Chromatography

We present membrane-based steric exclusion chromatography (SXC) as a universal capture step for purification of adeno-associated virus (AAV) gene transfer vectors independent of their serotype and surface characteristics. SXC is performed by mixing an unpurified cell culture supernatant containing A... More


Protocol

Development and Validation of an Anion Exchange High-Performance Liquid Chromatography Method for Analysis of Empty Capsids and Capsids Encapsidating Genetic Material in a Purified Preparation of Recombinant Adeno-Associated Virus Serotype 5

The development of various manufacturing platforms and analytical technologies has substantially contributed to successfully translating the recombinant adeno-associated viral vector from the laboratory to the clinic. The active deployment of these analytical technologies for process and product cha... More


Protocol

Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines

Current guidelines recommend 15–20 g of carbohydrate (CHO) for treatment of mild to moderate hypoglycemia. However, these guidelines do not account for reduced insulin during suspensions with predictive low-glucose suspend (PLGS). We assessed insulin suspensions, hypoglycemic events, and CHO treatme... More


Protocol

Insulin Metrics: Need for Development of Consensus Standards for Reporting of Insulin Dosing Data

The advent of connected insulin pens will generate an avalanche of digital insulin data, especially in the context of prandial- and multiple daily injection-insulin regimens. There is a need for the diabetes community to develop standards for such data, analogous to what has been achieved using the ... More


Protocol

Continuous Glucose Monitoring Time-in-Range and HbA1c Targets in Pregnant Women with Type 1 Diabetes

The CONCEPTT trial compared real-time Continuous Glucose Monitoring (RT-CGM) to capillary glucose monitoring in pregnant women with type 1 diabetes. We analyzed CGM and glycated hemoglobin (HbA1c) measures in first (n = 221), second (n = 197), and third (n = 172) trimesters, aiming to examine target... More


Protocol

Correlates of Continuous Glucose Monitoring Use Trajectories in Children and Adolescents with Type 1 Diabetes

The goal of this study was to characterize trajectories of continuous glucose monitoring (CGM) use in youth 5–12 weeks after starting CGM and examine what factors differentiate between the trajectory groups. Parent–youth dyads completed assessments before starting CGM. Days of CGM use between weeks ... More


Protocol

Sustainable Use of a Real-Time Continuous Glucose Monitoring System from 2018 to 2020

We aimed to describe patterns of continuous glucose monitoring (CGM) system use and glycemic outcomes from 2018 to 2020 in a large real-world cohort by analyzing anonymized data from US-based CGM users who transitioned from the G5 to the G6 System (Dexcom) in 2018. The main end points were persisten... More


Protocol

School Nurse Perspectives on Do-It-Yourself Automated Pancreas Systems in the School Setting

Do-it-yourself (DIY) artificial pancreas systems (APSs) are gaining popularity among children with type 1 diabetes. Little is known about how school systems provide care for children who use DIY APSs, and available guidance for schools is limited. This study explored school staff perspectives on DIY... More


Protocol

High-Throughput In Vitro, Ex Vivo, and In Vivo Screen of Adeno-Associated Virus Vectors Based on Physical and Functional Transduction

Adeno-associated virus (AAV) vectors are quickly becoming the vectors of choice for therapeutic gene delivery. To date, hundreds of natural isolates and bioengineered variants have been reported. While factors such as high production titer and low immunoreactivity are important to consider, the abil... More


Protocol

Effective Targeting of Multiple B-Cell Maturation Antigen–Expressing Hematological Malignances by Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor T Cells

B-cell maturation antigen (BCMA) expression has been proposed as a marker for the identification of malignant plasma cells in patients with multiple myeloma (MM). Nearly all MM tumor cells express BCMA, while normal tissue expression is restricted to plasma cells and a subset of mature B cells. Cons... More


Protocol

Gene Therapy of the β-Hemoglobinopathies by Lentiviral Transfer of the βA(T87Q)-Globin Gene

β-globin gene disorders are the most prevalent inherited diseases worldwide and result from abnormal β-globin synthesis or structure. Novel therapeutic approaches are being developed in an effort to move beyond palliative management. Gene therapy, by ex vivo lentiviral transfer of a therapeutic β-gl... More


Protocol

Gene Therapy for X-Linked Severe Combined Immunodeficiency: Where Do We Stand?

More than 20 years ago, X-linked severe combined immunodeficiency (SCID-X1) appeared to be the best condition to test the feasibility of hematopoietic stem cell gene therapy. The seminal SCID-X1 clinical studies, based on first-generation gammaretroviral vectors, demonstrated good long-term immune r... More


Protocol

Adeno-Associated Virus-Based Gene Therapy for CNS Diseases

Gene therapy is at the cusp of a revolution for treating a large spectrum of CNS disorders by providing a durable therapeutic protein via a single administration. Adeno-associated virus (AAV)-mediated gene transfer is of particular interest as a therapeutic tool because of its safety profile and eff... More


Protocol

Adeno-Associated Virus Gene Therapy for Liver Disease

The field of adeno-associated virus (AAV) gene therapy has progressed rapidly over the past decade, with the advent of novel capsid serotype and organ-specific promoters, and an increasing understanding of the immune response to AAV administration. In particular, liver-directed therapy has made rema... More


Protocol

Gene Therapy in a Mouse Model of Niemann–Pick Disease Type C1

Niemann–Pick disease type C1 (NPC1) is a fatal congenital neurodegenerative disorder caused by mutations in the NPC1 gene, which is involved in cholesterol transport in lysosomes. Broad clinical manifestations of NPC1 include liver failure, pulmonary disorder, neurological deficits, and psychiatric ... More


Protocol

Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan

The development of genome-editing technology could lead to breakthrough gene therapy. Genome editing has made it possible to easily knock out or modify a target gene, while current gene therapy using a virus vector or plasmid hampering modification with respect to gene replacement therapies. Clinica... More


Protocol

Advances in Gene Therapy for Diseases of the Eye

Over the last few years, huge progress has been made with regard to the understanding of molecular mechanisms underlying the pathogenesis of neurodegenerative diseases of the eye. Such knowledge has led to the development of gene therapy approaches to treat these devastating disorders. Challenges re... More


Protocol

Gene Therapy for Hemoglobinopathies

Gene therapy for β-thalassemia and sickle-cell disease is based on transplantation of genetically corrected, autologous hematopoietic stem cells. Preclinical and clinical studies have shown the safety and efficacy of this therapeutic approach, currently based on lentiviral vectors to transfer a β-gl... More


Application

A Fast and High Precision Influenza Vaccine Potency Assay

Fast and accurate determination of vaccine titre during influenza vaccine manufacture is important in understanding process performance and correctly scaling each process step. Traditionally assays such as Single Radial Immunodiffusion (SRID) and ELISA have their limitations; SRID, though the ‘gold ... More


Application

A Fast and High Precision Influenza Vaccine Potency Assay

Fast and accurate determination of vaccine titre during influenza vaccine manufacture is important in understanding process performance and correctly scaling each process step. Traditionally assays such as Single Radial Immunodiffusion (SRID) and ELISA have their limitations; SRID, though the ‘gold ... More


Application

Strategies for the Development of a High Throughput Octet® Bio-Layer Interferometry Method to Measure Pharmacokinetics of Monoclonal Antibodies in Preclinical Animal Models

Therapeutic antibodies are developed to treat various diseases, including cancers, immunological disorders, and infectious diseases. The safety and efficacy of these therapeutic molecules may be influenced by the way they interact with the body. Therefore, it is vital to understand how a body reacts... More


Application

Strategies for the Development of a High Throughput Octet® Bio-Layer Interferometry Method to Measure Pharmacokinetics of Monoclonal Antibodies in Preclinical Animal Models

Therapeutic antibodies are developed to treat various diseases, including cancers, immunological disorders, and infectious diseases. The safety and efficacy of these therapeutic molecules may be influenced by the way they interact with the body. Therefore, it is vital to understand how a body reacts... More


Application

Knock-out cell lines and their use in signaling pathways

Knock-out (KO) cell lines are powerful tools to study disease mechanisms, such as the effect of gene disruption on downstream pathways. In this application note, we highlight the effectiveness of Abcam KO cell lines that can be used to investigate signaling pathways, in this case, the TRAIL pathway.... More


Application

Knock-out cell lines and their use in signaling pathways

Knock-out (KO) cell lines are powerful tools to study disease mechanisms, such as the effect of gene disruption on downstream pathways. In this application note, we highlight the effectiveness of Abcam KO cell lines that can be used to investigate signaling pathways, in this case, the TRAIL pathway.... More


Application

Recombinant RabMAb®: Reliable antibodies for reproducible results

Poorly characterized antibodies often fail to provide consistent, reproducible results, thereby wasting materials, researcher time, and money. Compared to traditional polyclonal and monoclonal antibodies, recombinant antibodies exhibit very little batch-to-batch variability, providing scientists wit... More


Application

Recombinant RabMAb®: Reliable antibodies for reproducible results

Poorly characterized antibodies often fail to provide consistent, reproducible results, thereby wasting materials, researcher time, and money. Compared to traditional polyclonal and monoclonal antibodies, recombinant antibodies exhibit very little batch-to-batch variability, providing scientists wit... More


Application

Antibody conjugation guide

Antibody conjugation, also known as antibody labeling, is the process of chemically linking an antibody to a specific tag. There are many common methods used to conjugate antibodies, although they can have complex protocols and usually require a certain level of skill and expertise. In this guide, w... More


Application

Antibody conjugation guide

Antibody conjugation, also known as antibody labeling, is the process of chemically linking an antibody to a specific tag. There are many common methods used to conjugate antibodies, although they can have complex protocols and usually require a certain level of skill and expertise. In this guide, w... More


Primer

Analytical Weights and Balances: Minimizing Errors

Pharma companies that use balances for analytical purposes must check them regularly to ensure they meet required standards and to prevent human errors. The European Directorate for the Quality of Medicines Healthcare (EDQM) has recently published updated guidelines1 for analytical balancing that d... More


Primer

Nanomembrane Technology Rapidly Isolates Exosomes from Tears

Our tears reflect not only our emotions, but they also bear signatures of health and disease.Tears containnanoscale extracellular vesicles called exosomes that carryproteins and nucleic acids released from living cells. However, collecting exosomes from tears is restricted by low recovery, long proc... More


Primer

Fluorination Increases Bioavailability and Stability of Natural Therapeutics

A novel chemoenzymatic method can add fluorine atoms to natural compounds. The method uses an enzyme that acts as a gatekeeper for precursors and designs a pinch of precursor tolerance to create a more promiscuous bacterial enzyme that accepts fluorine-containing reactants.Fluorination of therapeuti... More


Primer

Orthogonal Validation in Genome Editing Discovery Work

Simply put, orthogonal validation uses additional methods that provide very different selectivity to the primary method to confirm or refute a finding. All methods are independent approaches that can answer the same question and are used to evaluate and verify the findings. According toClarence Mill... More


Primer

Solvent Precipitation Method Increases Protein Recovery for Proteomics

Study designs in proteomics aim for inclusivity—to characterize every protein in a sample. However, extracting proteins from complex biological samples involves the use of harsh buffers containing detergents and salts that are incompatible with the proteomics workflow. More proteins are lost in atte... More


Primer

Nanotip Stabilization Enables Prolonged Nanoscale Imaging of Large Samples

An innovation that stabilizes the nanotip used in tip-enhanced Raman spectroscopy (TERS) prolongs the imaging time window well beyond the current 30 minute limit. Scientists have demonstrated that the enhanced system is capable of imaging nanoscale defects over six hours in a micrometer-sized, two-d... More


Primer

Behavior of Metal Bearing Nanomaterials in Biosystems

Nanomaterials are being engineered to facilitate a range of applications in diagnosing diseases and delivering drugs. The widespread adoption of nanotechnological applications in medicine rests on the ability to safely target nanomaterials and understand how they behave in biological tissue environs... More


Primer

Cloning Mice From Freeze Dried Somatic Cells

As species continue to face massive extinction, preserving genetic material through judicious biobanking to enable cloning is key to promoting the survival of species and maintaining biodiversity.Embryos and germ cells are commonly stored at ultra-low temperatures in liquid nitrogen. But storing rep... More


Primer

Rapid Detection of Diverse Infectious Agents in Skin Interstitial Fluid

A rapid and reliable skin-patch test1 can now detect the COVID-19 virus, and potentially other infectious agents in under three minutes, without the need to draw blood. This convenience overcomes a current challenge in identifying infected individuals who are averse to blood tests and could help res... More


Primer

Techniques to Detect Unusual Nucleic Acid Structures

Guanine quadruplexes (G-quadruplexes or G4s) are unusual nucleic acid structures with distinct biological and chemical functions. They have occupied significant attention in the nucleic acid world since they were first identified in 1962 as the basis for the aggregation of 5’-guanosine monophosphate... More


Mixer

Spatial Biology Tools and Techniques

Single-cell spatial phenotyping is transforming biomedical research in fields ranging from oncology to neuroscience. This GEN Protocols Mixer focuses on technological developments and protocols that have enabled spatial approaches in biology. We will explore novel applications of the technology in d... More


Mixer

Soft Skills Needed in the Biotech Workforce

Being a professional in a successful life science company--be it a CRO, a CDMO, a startup, a mid- to medium-sized biotech firm, or an established company with a track record of popular products--requires much more than academic credentials, research expertise and technical knowhow. Soft skills are t... More


Mixer

Organoids for Airway and Alveolar Disease Modeling

In this Mixer, we discussed the development of respiratory airway and alveolar organoids derived from human iPSCs and how these are used in modeling respiratory diseases such as cystic fibrosis. Airway organoid models can be used for testing the therapeutic efficacy of candidate drugs for respirator... More


Mixer

Cell Therapy: Autologous vs Allogeneic Cell Expansion

This Mixer discusses culture systems, integrated consumables, and technical considerations for cell expansion processes in the production of autologous and allogeneic cell therapy products. Our expert panelists will discuss the implementation of scalable, cost-efficient technologies and process opti... More


Mixer

Mapping Tissue Carbohydrates Using Mass Spectrometry

This mixer will be relevant for all interested in methods used in glycoproteomics research that aims to understand the pivotal role of carbohydrate motifs that modify the proteome.Glycoproteomics, a dynamic area of frontier research, provides a systems biology approach to understanding the biologica... More


Mixer

Viral Titer Assays and Interpretations

In this Mixer we will discuss some common methods used to measure viral titers and considerations one should bear in mind when interpreting the results from different assays used to quantify virus particles.Along with all things virology, the recent pandemic has led to focused interest in the accura... More


Mixer

Cell Therapy Development: Tackling Analytic Challenges

Cell therapy products are an exciting new class of medicinal products that offer opportunities to treat and cure diseases that cannot be treated using conventional therapeutic options. The development and manufacturing of cell therapy products pose several challenges compared to other biologics. Yet... More


Video

GEN Protocols Expert Exchanges: Single-Cell RNA Sequencing--Challenges and Solutions

Biological resolution at the level of individual cells is the only route to understanding biological organisms that are a heterogenous composite of different cell types. Single-cell technology is powering the next phase of basic research in biology, translational enquiries, and strategies for person... More


Video

GEN Protocols Expert Exchanges: Nanoparticles in Precision Medicine Diagnostics and Delivery

Particles in the size-range of one to 100 nanometres called nanoparticles exhibit significantly different physical and chemical properties owing to their large surface area to volume ratio. Nanoparticles are finding new applications in medicine. They can combine diagnosis and delivery into one devic... More


Video

GEN Protocols Expert Exchanges: Critical ALS Biomarkers of Neuroinflammation & Oxidative Stress

Biomarkers are essential tools for the development of therapeutics, clinical trial design and patient stratification. Biomarkers also help evaluate the efficacy of therapeutic intervention on disease progression or relapse. Yet, biomarker driven patient stratification, a hallmark in oncology trials,... More


Video

GEN Protocols Expert Exchanges: Patient-Derived Pancreatic Cancer Organoids Predict Response to Therapy

Pancreatic cancer accounts for three percent of all cancers in the United States and is responsible for seven percent of all cancer deaths. Miniature organoids cloned from pancreatic tumors in patients are being grown in laboratories to conduct assays that can predict the effectiveness of chemother... More


Video

GEN Protocols Expert Exchanges: COVID-19 Immunodiagnostic Test Identifies Antibody Source

Need another COVID-19 booster?A new immunodiagnostic test called PictArray helps you decide. The test tells you exactly where your antibodies to the virus are coming from - whether your antibodies are from vaccines or SARS-CoV-2 infections, or both. The test detects SARS-CoV-2 antigens--both spike p... More


Audio

GEN Protocols Expert Exchanges: Next Generation Techniques to Develop Genetic Medicines

The past decade has seen a shift in drug discovery to include targeting the root cause of genetic diseases: loss-of-function, gain-of-function, and change-of-function mutations in the genome. Although first generation genetic medicines like gene therapies heralded a new approach to treating previous... More


Video

GEN Protocols Expert Exchanges: Tools and Techniques to Develop Therapies for Neurological Disorders

The human brain is an exquisitely complex organ, consisting of nearly one hundred billion neurons, an equivalent number of non-neuronal cells and trillions of synapses. Understanding the factors that play a role in the development of the structure and function of the brain is an essential step to de... More


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