(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
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Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
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Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
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Promising broader patient access to critical medicines, biosimilars offer a more cost-effective alternative therapeutic option compared with originator products. With
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BioAgilytix adds New VP of Business Development in Europe Hamburg, Germany 01 March 2023 – BioAgilytix, a leading global bioanalytical
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78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
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(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
Share This Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
Share This Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
Share This Promising broader patient access to critical medicines, biosimilars offer a more cost-effective alternative therapeutic option compared with originator products. With
Share This BioAgilytix adds New VP of Business Development in Europe Hamburg, Germany 01 March 2023 – BioAgilytix, a leading global bioanalytical
Share This 78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
Share This Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
Share This 3 key challenges facing the biosimilars space in 2023 In 2010, the biopharma industry saw an abrupt patent cliff: a
Share This As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
Share This
BioAgilytix is singularly committed to providing you with the scientific and regulatory expertise needed to overcome bioanalytical complexities and avoid quality pitfalls in every phase of development. Put your small and large molecule therapeutics in our expert hands, and we will give you the confidence of the most accurate, precise, and comprehensive high-quality scientific processes and data – with results that are delivered right on time, and right the first time.
BioAgilytix provides integrated science, technologies, information, and services. We achieve this through a sustainable Quality Management System (QMS) built upon four key pillars:
Customer Understanding
BioAgilytix fosters deep insights into the working environment of our customers and identifies what they need to make their work simpler and safer.
Performance and Reliability
BioAgilytix employs principles of design excellence to provide services that consistently address the needs of customers and other stakeholders. We develop and deliver services of superior quality and reliability that create high levels of customer loyalty.
Regulatory Compliance
BioAgilytix is committed to the highest levels of regulatory compliance and maintains a QMS that demands superior performance in everything we do.
Ownership and Accountability
BioAgilytix takes ownership and accountability for a QMS.
Robust implementation and continuous education ensure the effectiveness of our quality system. Each day, we work to establish and monitor measurable quality objectives in order to deliver successful results for our sponsors.
“BioAgilytix Labs (BAL) is a contract laboratory registered with the FDA (FEI#3007929739) and has an established reputation of complying with the relevant national and international regulations and guidelines of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). BAL has a robust Quality Management System (QMS) detailed in a Quality Manual that details the BAL quality policy and a set of quality procedures that outline the necessary documented controls and compliance measures to ensure continual quality monitoring and improvement.”
While standards like Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) are essential, they are not necessarily sufficient in defining the kind of advanced quality commitment that is demanded in the most complex bioanalytical projects and applications. Advanced quality in bioanalytical services means more than strictly adhering to standards. In order for a quality commitment to be truly advanced, quality must permeate every aspect of operations, spanning data integrity, as well as safety, responsibility, and innovation. To that end, BioAgilytix maintains a quality manual that is strictly adhered to.
The Quality Manual documents are the organizational responsibilities, operations / systems, activities, quality policy, and procedures established for effective operation of BioAgilytix’s QMS. Encompassed within the manual are identifiable processes and systems that demonstrate adherence to applicable GxP (GLP, GCP, and GMP) regulatory requirements and standards.
BioAgilytix’s labs operate in accordance with 21 CFR Part 58 and our European lab is GLP certified. Our labs in Boston, MA and Durham, NC are also CLIA certified to perform lab-developed tests that are subject to CLIA oversight. Our Durham laboratory is additionally able to offer services under GMP.
BioAgilytix’s Quality team is responsible for providing an effective and efficient system and regulatory counsel for our operational units, addressing QA aspects related to our science, technologies, information, and services in a cohesive manner. Quality operates independently from these operational units and regularly performs quality review activities (e.g. in phase inspections, process / facility inspections, and vendor audits) to ensure compliance with appropriate regulatory regulations.
BioAgilytix ensures quality with the employment of a highly experienced team devoted to compliance with appropriate regulations, policies, and operations. Averaging over 20 years of experience in bioanalytical quality assurance, our knowledgeable Quality team has extensive experience working in quality assurance and regulated environments. Their proven ability to uphold advanced quality is what helps BioAgilytix lead the industry standard for excellence in small and large molecule bioanalysis and related operations.
Our Quality team consists of leaders in Quality organizations, who have veteran experience supporting quality initiatives across a number of therapeutic areas. They are particularly experienced in upholding compliance to relevant GLP, GCP, GMP, and CLIA regulations and guidances, as well as in developing procedures and processes that support continual quality improvement.
Discover how Angela supports the premium science that we deliver each day in a Q&A session where she tells us about her expanding role at BioAgilytix.
In addition to scientific rigor and technological advancement, quality is among the most critical indicators of bioanalytical CRO capability and performance. In order to ensure the integrity of results and the ability to meet pressing turnaround times, quality must not simply be a check in a box – but instead an integral pillar of sustained excellence.
By adopting an advanced quality mindset in every aspect of our daily work, we live out the dimensions of our quality commitment each day.
Process is foundational to quality excellence. Our cohesive and collaborative quality team consistently upholds the highest quality and delivers on our commitment to provide superior science.
Integrity is an essential element of our advanced quality commitment. In a bioanalytical facility, integrity is upholding reliability, communication and transparency at every point in the client engagement. When it comes to quality, integrity means strict adherence to GxPs.
As an advanced quality facility, we are continually looking for quality improvements. We offer an array of advanced bioanalytical platforms, applying the same level of quality across each of these technologies – whether long-leveraged or newly emerging.
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
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
617-456-0700
Fax 617-456-0701
1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
85 Commercial Road, Melbourne
Victoria, 3004, Australia
+61 3 9282 2184
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
85 Commercial Road, Melbourne
Victoria, 3004, Australia
+61 3 9282 2184
Copyright © 2023 BioAgilytix Labs.
All rights reserved.
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
5927 S. Miami Blvd. Suite 100
Morrisville, NC 27703
919-381-6097
Fax 919-381-6099
1320 Soldiers Field Road
Boston, MA, 02135
Office 617-456-0700
Fax 617-456-0701
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
37 Kent St, Woolloongabba
Queensland, 4102, Australia
85 Commercial Road, Melbourne
Victoria, 3004, Australia
03 9282 2184
Copyright © 2023 BioAgilytix Labs.
All rights reserved.
Terms of Use | Privacy Notice
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
5927 S. Miami Blvd. Suite 100
Morrisville, NC 27703
919-381-6097
Fax 919-381-6099
1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
37 Kent St,Woolloongabba
Queensland, 4102, Australia
85 Commercial Road, Melbourne
Victoria, 3004, Australia
03 9282 2184
Copyright © 2023 BioAgilytix Labs.
All rights reserved.
