
[EPISODE 24] Dr. David Berkowitz Talks Enzymes, Radiation, And The Lincoln Marathon
On this episode of Molecular Moments, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
(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, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
Promising broader patient access to critical medicines, biosimilars offer a more cost-effective alternative therapeutic option compared with originator products. With
78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
3 key challenges facing the biosimilars space in 2023 In 2010, the biopharma industry saw an abrupt patent cliff: a
As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
(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, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
Promising broader patient access to critical medicines, biosimilars offer a more cost-effective alternative therapeutic option compared with originator products. With
78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
3 key challenges facing the biosimilars space in 2023 In 2010, the biopharma industry saw an abrupt patent cliff: a
As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
BioAgilytix has deep expertise in the bioanalytical support needs of autoimmune drug development. By leveraging our team’s veteran insights in autoimmune diseases, our team is set-up to produce successful results in even the most complex studies.
Autoimmune diseases are chronic and debilitating conditions which are caused by an immune-mediated self-destruction of tissues or organs. The causes are not fully understood but the clinical impact is significant. Diseases and syndromes such as rheumatoid arthritis, Graves’ Disease, or systemic lupus erythematosus are some of the most prominent examples for these pathological findings. Until recently, their symptomatic treatment was mostly based on immune suppressive small drugs. However, novel treatment options are evolving rapidly for this class of diseases. Beyond TNF-alpha inhibition, there are a number of promising biological therapies in the pipeline that are designed to modify the immune response. Moreover, there are drug candidates which may be curative or may prevent the immune hyperreactivity.
Because autoimmune diseases are characterized by polyclonal immune stimulation, these disease entities are more prone to immune responses against biological drugs. Particular care should be taken when assessing the immunogenicity of biological drugs. For instance, anti-drug antibodies may not only lead to a loss or reduction of efficacy, but also to an unobserved clinical latent progression of the autoimmune disease. In addition to measuring ADA and NAb, controlling the PK and the analysis of specific biomarkers are extremely important to monitoring patients. Hence, pharmaceutical and biotechnology companies involved in autoimmune drug development will need an effective CRO partner, that has significant bioanalytical and clinical expertise and knowledge in this complex space, to ensure the highest quality results.
Today’s pharmaceutical and biotechnology organizations need a scientific partner that can help them constantly innovate and evolve to meet novel requirements of developing increasingly effective (but increasingly complex) biotherapeutic innovations.
Autoimmune-related drug development is a true area of expertise for BioAgilytix. This is reflected in the comprehensive services we provide spanning from discovery through Phase I, II, II and IV. Throughout the study, our GLP/GMP lab confirms that assay data supports the requirements of regulated bioanalysis.
Our scientists are constantly expanding their expertise in all autoimmune disease states. However, we have specific expertise analyzing compounds and biotherapeutics that target conditions including in lupus, inflammation discovery, rheumatoid arthritis, and respiratory diseases.
The following services are regularly used in autoimmune-related studies at BioAgilytix:
Our autoimmune-related services are carried out using a specialized selection of state-of-the-art technologies and platforms that are designed to improve the quality of an autoimmune study’s process and data. BioAgilytix is well versed in the bioanalytical support needs of autoimmune drug development. Our expert scientists strategically implement the best-fit technologies to overcome your autoimmune project’s most challenging barriers. A sample of the platforms we typically leverage is featured below:
Explore our array of white papers, articles, and videos to gain deeper insight into our small and large molecule expertise, and to stay updated with the latest news and research coming from the field of bioanalysis.
To continue innovating, we understand that pharmaceutical and biotechnology companies are in need of a CRO partner that can help develop safer, more effective biotherapeutic solutions for inherently complex autoimmune diseases.
BioAgilytix is an experienced provider of autoimmune disease-related bioanalytical services that are supported by deep scientific expertise and advanced technology. Our scientists have decades of experience that have contributed to producing the most accurate and comprehensive scientific results possible in various autoimmune matrices including plasma, serum, BAL, sputum and synovial fluid. In fact, BioAgilytix has more than 30 validated assays for autoimmune conditions.
Look to BioAgilytix for an expert partner to support your autoimmune studies from discovery through to Phase IV.