Search our Resource Library to view our publications covering biologics, gene, and cell analytics.
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White Paper
Content and Degradation of Polysorbates in Biopharmaceutical Formulations
Quality Control of AAV Capsid Loading
Publications
Restoration of T and B Cell Differentiation after RAG1 Gene Transfer in Human RAG1 Defective Hematopoietic Stem Cells
LC-MS Approach to Decipher a Light Chain Chromatographic Peak Splitting of a Monoclonal Antibody
Articles
10 Key Studies to Secure a Successful BLA Submission
Empowering Innovation: ProtaGene's Analytical Solutions Amid Market Flux
Spotlight
mRNA-based Therapeutic Products: CMC Solutions for Enabling Development
Risk Mitigation of Your Host Cell Protein Control Strategy
5 Reasons Antibody Therapeutic Developers Are Turning to ProtaGene
Podcast
BioInsights Interview: Navigating the Complexities of Biodistribution, Transgene Expression & Vector Shedding in Gene Therapy Development with Paul Byrne
Video
Inside Our Lab Video: Molecular Bioanalysis
PharmaVoice: 3 Pressing Molecular Bioanalysis Factors Confronting Gene Therapy Developers
Solution Brief
Antibody-Based Therapeutic Development Made Easy
Vector Shedding Analysis for Clinical Assessment of Viral Vector Gene Therapies and Safety Risk in Preclinical Development
Biodistribution & Transgene Expression of Viral Vector Gene Therapies: Assessing Risk and Therapeutic Effectiveness in Preclinical Development
Molecule to Market Podcast: The Iterative Nature of Emerging Therapeutics with Jennifer Chadwick, PhD
Host Cell Protein Detection and Analysis—4 Things You Need to Know
Innovation Spotlight: Advanced AAV Capsid Analysis
How Sound is Your Data? Sound Support for Your Program At Every Stage
Development of Protein-Specific Analytical Methodologies to Evaluate Compatibility of Recombinant Human (rh)IGF-1/rhIGFBP-3 with Intravenous Medications Co-Administered to Neonates
Fact Sheet
Corporate Overview: Advanced Analytical Solutions
Host Cell Protein Detection Gap Risk Mitigation: Quantitative IAC-MS For ELISA Antibody Reagent Coverage Determination
Can Phase III Biosimilar Studies be Eliminated?
Integration Site Analysis: S-EPTS/LM-PCR
Opportunity Abounds as the Biosimilars Market Prepares for the Next Biologics Patent Cliff
ProtaGene Weighs in on the Future of the Biosimilars Market
Brochure
Analytics for Biologics: Stability Studies
Infographic
Your Guide to Host Cell Protein Analysis
The 5 Advantages of LC-MS-based Host Cell Profiling
5 Benefits to Outsourcing Your Stability Studies to a Trusted CRO
Application Note
Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies
Evaluating the State of the Science for Adeno-Associated Virus (AAV) Integration: An Integrated Perspective
6 Analytical Strategies to Consider Before Submitting Your Cell and Gene Therapy Application
Intact Mass Analysis for Accelerated Development and Approval of Biologics
Mass Spectrometry-based Host Cell Protein Analysis in Biologics Development
Presentation
Rapid Analysis of Oligonucleotides by High-Resolution Accurate Mass CE-MS
HIV- 1 Lentivirus Tethering to the Genome is Associated with Transcription Factor Binding Sites Found in Genes That Favour Virus Survival
Analytical Solutions for Residual Nucleic Acid Detection in Gene Therapy Vectors
Long-term Outcomes of Lentiviral Gene Therapy for the β-hemoglobinopathies: the HGB-205 Trial
Overcoming Analytical Challenges for Gene Therapies
Betibeglogene Autotemcel Gene Therapy for Non-β 0/β 0 Genotype β-Thalassemia
Common Clonal Origin of Conventional T cells and Induced Regulatory T Cells in Breast Cancer Patients
New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study
Spatial–Temporal Variations in Atmospheric Factors Contribute to SARS-CoV-2 Outbreak
VSeq-Toolkit: Comprehensive Computational Analysis of Viral Vectors in Gene Therapy
Analytical Artifacts in Characterization of Recombinant Monoclonal Antibody Therapeutics
Impact of Glycosylation on the Comparability of the Higher-Order Structures by Hydrogen-Deuterium Exchange Mass Spectrometry
Spatially Clustered Loci With Multiple Enhancers Are Frequent Targets of HIV-1 Integration
Mass Spectrometric Evaluation of Upstream and Downstream Process Influences on Host Cell Protein Patterns in Biopharmaceutical Products
Systematic Comparative Study of Computational Methods for T-Cell Receptor Sequencing Data Analysis
Comparative Next-Generation Sequencing of Adeno-Associated Virus Inverted Terminal Repeats
Structure, Heterogeneity and Developability Assessment of Therapeutic Antibodies
On-Demand Manufacturing of Clinical-Quality Biopharmaceuticals
Analytical Comparability Study of Recombinant Monoclonal Antibody Therapeutics
AAV Vector-Mediated In Vivo Reprogramming into Pluripotency
Mapping Active Gene-Regulatory Regions in Human Repopulating Long-Term HSCs
Genetic Subclone Architecture of Tumor Clone-initiating Cells in Colorectal Cancer
GENE-IS: Time-Efficient and Accurate Analysis of Viral Integration Events in Large-Scale Gene Therapy Data
Lentiviral Vector Promoter is Decisive for Aberrant Transcript Formation
Identification of Low Abundant Isomeric Glycan Structures in Biological Therapeutics by LC/MS
Assessing In Vivo Dynamics of Multiple Quality Attributes from a Therapeutic Monoclonal Antibody Circulating in Cynomolgus Monkey
Tracking Genetically Engineered Lymphocytes Long-Term Reveals the Dynamics of T-Cell Immunological Memory
A Graph Based Framework to Model Virus Integration Sites
Generation of Lentivirus-induced Dendritic Cells Under GMP-compliant Conditions for Adaptive Immune Reconstitution Against Cytomegalovirus After Stem Cell Transplantation
Presence of a trs-Like Motif Promotes Rep-Mediated Wild-Type Adeno-Associated Virus Type 2 Integration
High-Resolution Analysis of the Human T-Cell Receptor Repertoire
High-Throughput Monitoring of Integration Site Clonality in Preclinical and Clinical Gene Therapy Studies
Preclinical Evaluation of Efficacy and Safety of an Improved Lentiviral Vector for the Treatment of β-Thalassemia and Sickle Cell Disease
Gene Therapy for Wiskott-Aldrich Syndrome–Long-Term Efficacy and Genotoxicity
Linear Amplification Mediated PCR–Localization of Genetic Elements and Characterization of Unknown Flanking DNA
From Bench to Bedside: Preclinical Evaluation of a Self-Inactivating Gammaretroviral Vector for the Gene Therapy of X-linked Chronic Granulomatous Disease
Comparability Analysis of Anti-CD20 Commercial and RNAi-mediated Fucosylated Antibodies by Two LC-MS Approaches
Identification of Potential Glycan Cancer Markers with Sialic Acid Attached to Sialic Acid and Up-regulated Fucosylated Galactose Structures in Epidermal Growth Factor Receptor Secreted from A431 Cell Line
A Largely Random AAV Integration Profile after LPLD Gene Therapy
Lentiviral Hematopoietic Stem Cell Gene Therapy Benefits Metachromatic Leukodystrophy
Lentiviral Hematopoietic Stem Cell Gene Therapy in Patients with Wiskott-Aldrich Syndrome
Parallel Assessment of Globin Lentiviral Transfer in Induced Pluripotent Stem Cells and Adult Hematopoietic Stem Cells Derived from the Same Transplanted β-Thalassemia Patient
Integrase-Deficient Lentiviral Vectors Mediate Efficient Gene Transfer to Human Vascular Smooth Muscle Cells with Minimal Genotoxic Risk
LC-MS Analysis of Polyclonal Human Anti-Neu5Gc xeno-autoantibodies Immunoglobulin G Subclass and Partial Sequence Using Multistep Intravenous Immunoglobulin Affinity Purification and Multienzymatic Digestion
Complete Mapping of a Cystine Knot and Nested Disulfides of Recombinant Human Arylsulfatase A by Multi-Enzyme Digestion and LC-MS Analysis Using CID and ETD
Bioinformatic Clonality Analysis of Next-Generation Sequencing-Derived Viral Vector Integration Sites
An Unbiased Genome-Wide Analysis of Zinc-Finger Nuclease Specificity
Analyzing the Number of Common Integration Sites of Viral Vectors – New Methods and Computer Programs
Insertion Sites in Engrafted Cells Cluster within a Limited Repertoire of Genomic Areas after Gammaretroviral Vector Gene Therapy
Genome-Wide High-Throughput Integrome Analyses by NRLAM-PCR and Next-Generation Sequencing
Comprehensive Genomic Access to Vector Integration in Clinical Gene Therapy
Hematopoietic Stem Cell Gene Therapy with a Lentiviral Vector in X-Linked Adrenoleukodystrophy
Gammaretrovirus-Mediated Correction of SCID-x1 Is Associated with Skewed Vector Integration Site Distribution In Vivo
High-resolution Insertion-site Analysis by Linear Amplification-mediated PCR (LAM-PCR)
Real-Time Definition of Non-Randomness in the Distribution of Genomic Events
Correction of X-linked Chronic Granulomatous Disease by Gene Therapy, Augmented by Insertional Activation of MDS1-EVI1, PRDM16 or SETBP1
Detection and Direct Genomic Sequencing of Multiple Rare Unknown Flanking DNA in Highly Complex Samples
Clonality Analysis After Retroviral-mediated Gene Transfer to CD34+ Cells from the Cord Blood of ADA-deficient SCID Neonates
LMO2-associated Clonal T Cell Proliferation in Two Patients After Gene Therapy for SCID-X1
