
[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)
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CRO
Immunoassay
Mass Spectrometry
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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
Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
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
BioAgilytix adds New VP of Business Development in Europe Hamburg, Germany 01 March 2023 – BioAgilytix, a leading global bioanalytical
78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
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
(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
Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
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
BioAgilytix adds New VP of Business Development in Europe Hamburg, Germany 01 March 2023 – BioAgilytix, a leading global bioanalytical
78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
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
Rely on the combined power of BioAgilytix’s veteran scientists, advanced platforms, and validated techniques to quickly progress the development of your promising biosimilars. Our scientists have experience supporting biosimilar studies with a number of assays for generics, including ligand binding assays, characterization, and stability testing on multiple platforms.
A biosimilar is a biological product that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. Biosimilars are not to be confused with generic chemical medicines, which use identical active ingredients. It is critical to demonstrate the comparability of a biosimilar to its originator product not only to ensure safety and efficacy but also to allow for drug substitution and exchangeability.
The Biosimilars Council reports that by 2020, brand biologic medicines worth an estimated $81 billion in global annual sales will lose their patents. This provides a significant opportunity for the development of lower cost biosimilar alternatives, and the biosimilars market is expected to expand more than 20-fold in the next 5 years.
For more information on why it is critical to establish analytical and bioanalytical equivalency between biosimilars and originators – and the unique challenges this presents.
The rise of biosimilars brings with it the promise of broader patient access to important medicines for serious diseases. BioAgilytix is committed to supporting this area of innovation by bringing together the best scientists, technologies, and processes needed to develop and deliver reliable, high-quality biosimilars for a wide range of disease states.
Our scientists have experience supporting biosimilar studies with ligand binding assays, characterization, and stability testing on multiple platforms. We also possess robust expertise in analyzing samples from rodents, humans, and non-human primates under non-GLP, GLP, and in performing analyses under GMP regulations.
BioAgilytix is highly knowledgeable in the sensitivities of biologics development, and understands the challenges that biosimilar developers face. We have leading experience using the following platforms from our extensive technology suite to conduct immunogenicity and PK studies, biomarker studies, cell-based assays, ADA analyis, and NAb assays supporting biosimilars development.
Learn more about the most recent best practices for biosimilar assessment with this article from The American Association of Pharmaceutical Scientists (AAPS) biosimilar focus group.
The surge of upcoming patent expiries has driven demand for biosimilars – but without access to the originator’s molecular clone and cell bank, the exact fermentation and purification process, or the active drug substance, mimicking the performance of the branded original is extremely complex. Averaging over 15 years of bench experience, our veteran team of BPMs have world-leading expertise in biosimilars development, and will apply that knowledge to optimally support your project. We are able to offer services under GLP, GMP, and GCP to meet your distinct regulatory requirements.
The rise of biosimilars brings with it the promise of broader patient access to important medicines for serious diseases. BioAgilytix is committed to supporting this area of innovation by bringing together the best science, technologies, and processes needed to develop and deliver reliable, high-quality biosimilars for a wide range of disease states. Let our specialized scientists help you identify the optimal method and platform for your pharmacokinetic assay needs today.
Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment.
Gouty D, Cai CC, Cai XY, Kasinath A, Kumar V, Alvandkouhi S, Yang J, Pederson S, Babbitt B, Peritt D, Rudy A, Koppenburg V, Dasilva A, Ullmann M, Liu S, Satterwhite C. AAPS J. 2017 Dec 28;20(1):25. doi: 10.1208/s12248-017-0181-6.
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Meeting the Rigorous Demands of Biosimilar Pharmacokinetics
Mansouri S, Zemo J, Alligood K. International Journal of Pharmacokinetics 2017 Jan; DOI 10.4155/ipk-2016-0024.
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Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.
Cai XY, Wake A, Gouty D. Bioanalysis. 2013 Mar; 5(5):517-20. doi: 10.4155/bio.13.1.
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Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development.
Cai XY, Gouty D, Baughman S, Ramakrishnan M, Cullen C. Bioanalysis. 2011 Mar; 3(5):535-40. doi: 10.4155/bio.11.24. Review.
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