
[EPISODE 25] Adam Stasio Talks, Large Data Sets, Breaking Down Problems, and Tech-Driven Solutions
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
~34,000 sq. ft.
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
~265,000 sq. ft.
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
~22,000 sq. ft.
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
~2,900 m2 (31,000 sq. ft.)
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, have
BioAgilytix Commits to United Nations Global Compact Leading bioanalytical services provider pledges to act in support of human rights
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive
An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of
(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
~34,000 sq. ft.
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
~265,000 sq. ft.
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
~22,000 sq. ft.
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
~2,900 m2 (31,000 sq. ft.)
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, have
BioAgilytix Commits to United Nations Global Compact Leading bioanalytical services provider pledges to act in support of human rights
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive
An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of
Gene therapy uses sections of DNA to introduce genetic material into a patient’s cells to treat or prevent disease. The new DNA contains a functioning gene to correct the effects of a disease-causing mutation. Genes are delivered to a cell using carriers called ‘vectors’, which are most commonly viruses that have been altered to make them safe. The adeno-associated virus (AAV) is the most popular viral vector used for gene therapy work today, because of its current lack of pathogenicity and ability to infect both dividing and quiescent cells and persist in an extrachromosomal state without integrating into the genome of the host cell. Lentivirus, due to their flexible genome and potential of transducing many forms of nondividing cells, have also become one of the most widely used vectors for gene transfer.
Due to its targeted nature, gene therapy offers much promise for treatment of numerous diseases, from cancer to Parkinson’s, Alzheimer’s, heart disease, diabetes, and more. According to a recent report on global trends in gene therapy, this area has seen such promising success that the number of gene therapy products in development doubled between 2012 and 2015. In fact, as of 2016 a total of 201 cancer gene therapy products (and 102 for monogenic diseases) were in commercial development. But there are also complexities that make gene therapy development challenging. It is crucial the new gene reaches the correct cell without causing an immune response or disrupting the function of other genes. All this requires deep scientific skill and expertise in the development of appropriate vectors.
Find valuable resources from our scientists who share their expert perspectives on evolving methods and trends in cell & gene therapy bioanalysis.
BioAgilytix boasts extensive experience analyzing gene therapy solutions across viral vectors, leveraging NAb assays to test for neutralizing activity against the vector of gene therapy. Specifically, we test for neutralizing activity against the viral vector of interest. Our assays are based on positive sera from human subjects that is used at the positive control, purchased at a vendor and tested in our lab, so we do not simply test for neutralizing antibodies, but any neutralizing activity.
For those customers interested in determining antibody neutralizing activity specifically, we do so by using a surrogate / purified antibody. The viral vectors with a marker are convenient tools to monitor how their infectivity on cells in culture is affected by positive neutralizing control serum.
BioAgilytix is committed to supporting our customers’ gene therapy innovations by investing in state-of-the-art instrumentation that delivers the high levels of sensitivity and reliability neutralizing activity analysis demands. We have leading experience using the following platforms from our extensive technology suite to conduct gene detection, gene expression analysis, genetic variation analysis, and array data validation supporting gene therapy development.
BioAgilytix is highly knowledgeable in the sensitivities and changing landscape of gene therapy development, and we understand both the scientific and regulatory challenges that gene therapy developers face. As an advanced bioanalytical laboratory, we comply with all GLP, GMP, and GCP guidelines, and maintain a Quality Management System (QMS) that demands superior performance in everything we do. We employ principles of design excellence to provide gene therapy-related services that consistently address customer needs throughout every phase of development.
Our veteran team of scientists has had extensive hands-on experience supporting gene therapy development efforts for many disease states, and will apply that knowledge to lead bioanalytical testing of your promising gene therapy products
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2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
37 Kent St,Woolloongabba
Queensland, 4102, Australia
1320 Soldiers Field Road
Boston, MA, 02135
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1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
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