Analytical Testing
Analytical Testing
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
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
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
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
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
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
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
Protocol
Skin Freezing Technique for Living Cell Bank
Cell banks are especially important sources of studies for which living cells are needed, as well as a repository of genetic diversity in natural populations. We propose a simple protocol for field research that can maintain viable skin cells for in vitro replication and production of fibroblast lin... More
Protocol
Protein Aggregate Identification with FMM: Rapidly Distinguish Protein from Non-Protein Particles in Biologic Formulations
Don’t rely on unreliable morphology characteristics or refractive index to determine if particles in your formulation are protein or non-protein. Aura systems are the only particle analyzer that combines fluorescence membrane microscopy (FMM) with backgrounded membrane image (BMI) to give you defini... More
Protocol
High-Throughput Detection of Degraded Polysorbate in Biological Formulations with FMM
Excipients like polysorbate are used in the majority of biologic products to improve stability. However, the polysorbate itself can degrade, impairing the stability of the API and contributing an additional aggregate source that can elicit an immunogenic response. Traditionally, monitoring only poly... More
Protocol
Skin Freezing Technique for Living Cell Bank
Cell banks are especially important sources of studies for which living cells are needed, as well as a repository of genetic diversity in natural populations. We propose a simple protocol for field research that can maintain viable skin cells for in vitro replication and production of fibroblast lin... More
Protocol
Protein Aggregate Identification with FMM: Rapidly Distinguish Protein from Non-Protein Particles in Biologic Formulations
Don’t rely on unreliable morphology characteristics or refractive index to determine if particles in your formulation are protein or non-protein. Aura systems are the only particle analyzer that combines fluorescence membrane microscopy (FMM) with backgrounded membrane image (BMI) to give you defini... More
Protocol
High-Throughput Detection of Degraded Polysorbate in Biological Formulations with FMM
Excipients like polysorbate are used in the majority of biologic products to improve stability. However, the polysorbate itself can degrade, impairing the stability of the API and contributing an additional aggregate source that can elicit an immunogenic response. Traditionally, monitoring only poly... More
Protocol
AAV Aggregate Quantitation and Identification with the Aura System
Adeno-associated viruses (AAVs) have made the promise of gene therapy a reality by enabling safe, targeted delivery of curative genetic payloads. The formation of aggregated viral vector is an important critical quality attribute to measure because they lead to adverse immunogenic events and are an ... More
Protocol
Detect Specific Protein Aggregates in Biologic Formulations with the Aura Immunoassay
Biologic co-formulations target multiple pharmacologically active sites to increase therapy efficacy. However, either biologic can be a source of protein aggregation that can negatively influence the product’s safety, efficacy, and therapy. Aura systems are the only particle analyzer that can pinpoi... More
Protocol
Evaluate Cell Therapy Product Purity with Aura CL
The CAR-T development workflow is a multi-step process that includes transfection of T cells with a viral vector to express a chimeric antigen and activation/expansion of the CAR-T using a molecule like a Dynabead conjugated to CD3/CD28. Each of these steps is a potential source of contamination tha... More
Protocol
USP Particle Count Standards with Aura and Particle Vue 3.1
All membrane microscopy methods must generate accurate and reproducible counts for bead counting standards. We present a validated methodology for accurately counting United States Pharmacopeia (USP) microsphere count standards on Aura systems by seamlessly calculating the cumulative area of all the... More
Protocol
USP Compendial Particle Measurements with the Aura System
The Aura platform provides a rapid and robust USP 788 compendial method for subvisible particle analysis, a critical quality attribute. It can handle a wide range of sample types and can analyze anywhere from 5 µL to 10 mL of sample, enabling continuity of method from developability assessment to lo... More
Protocol
Removal of rare undifferentiated induced pluripotent stem cells (iPSCs) by multi-step negative sorting
In the field of regenerative medicine involving ES or iPS cells, differentiated cells are often cultured to tissues and implanted to patients. However, there is an unneglectable problem that some remaining undifferentiated cells in the implanted tissue may cause tumors. Therefore, a complete removal... More
Protocol
Cell culture CO2 incubator decontamination process using hydrogen peroxide vapor for highly regulated and general cell culture protocols
The value of the laboratory cell culture incubator used in highly regulated research and clinical protocols is directly related to the proportion of incubator uptime vs. downtime in applications where frequent interior chamber decontamination is required or desired. The need for interior decontamina... 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
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
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
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
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
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: 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
Featured Content
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Primer
Techniques to Detect Unusual Nucleic Acid Structures -
Protocol
Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines -
Protocol
Preparing a Brain-Mimetic 3D Matrix for Culturing Human Pluripotent Stem Cells -
Protocol
Radiolabelling Nucleic Acids with [γ-32P] ATP for Analytical Assays -
Protocol
USP Compendial Particle Measurements with the Aura System - More