
[EPISODE 20] Dr. David Johnson Talks Frosted Flakes, Small Molecules, and Pharmacokinetics!
On this episode of Molecular Moments, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
(Automated Immunoassays)
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(Western Blot Imager)
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(Low Volume Automated ELISA)
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Virology
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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, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
Cell-based assays are an important tool in drug development. One of the biggest challenges when developing a drug is mimicking the
Summary In an article published by Pharmaceutical Technology Europe, BioAgilytix BioAgilytix supplies its assay expertise to describe the appropriate analytical
Summary In an Expert Opinion article published by Contract Pharma, PD Dr. Arno Kromminga of BioAgilytix discusses testing challenges and
Durham, NC, July 21, 2022 – BioAgilytix Labs, LLC (BioAgilytix) has secured a valuable seal of approval for the safety of
Durham, NC, June 30, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading global contract research organization focused on supporting pharmaceutical
Cell-based assays are an important tool in drug development. One of the biggest challenges when developing a drug is mimicking the
ADCC Antibody dependent cellular cytotoxicity (ADCC) is a mechanism in host immune defense where antibodies bind to an antigen on
Gene editing isn’t a new concept and has been around for decades. In its infancy, gene editing was time-consuming, inaccurate
(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 Square Feet
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
78,685 Square Feet
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
26,453 Square Feet
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
2,777 Square Meters
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, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
Cell-based assays are an important tool in drug development. One of the biggest challenges when developing a drug is mimicking the
Summary In an article published by Pharmaceutical Technology Europe, BioAgilytix BioAgilytix supplies its assay expertise to describe the appropriate analytical
Summary In an Expert Opinion article published by Contract Pharma, PD Dr. Arno Kromminga of BioAgilytix discusses testing challenges and
Durham, NC, July 21, 2022 – BioAgilytix Labs, LLC (BioAgilytix) has secured a valuable seal of approval for the safety of
Durham, NC, June 30, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading global contract research organization focused on supporting pharmaceutical
Cell-based assays are an important tool in drug development. One of the biggest challenges when developing a drug is mimicking the
ADCC Antibody dependent cellular cytotoxicity (ADCC) is a mechanism in host immune defense where antibodies bind to an antigen on
Gene editing isn’t a new concept and has been around for decades. In its infancy, gene editing was time-consuming, inaccurate
A partnership with BioAgilytix is a partnership with proven scientific excellence, rooted in a commitment to the most stringent GLP principles and processes.
As a GLP laboratory, we hold ourselves to the highest procedural standards, ensuring that our clients need not worry about compromises in the quality and integrity of results.
As defined by The Medicines and Healthcare Products Regulatory Agency (MHRA), “Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which studies are planned, performed, monitored, recorded, reported and archived… this helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.” First developed in 1978 by the FDA, the principles of Good Laboratory Practice (GLP) are promoted for international use by the Organization for Economic Co-operation and Development (OECD). A Good Laboratory Practice (GLP) is inherently designed to provide a verifiable testing record to the EPA or FDA.
GLP laboratories are laboratories that adhere to GLP standards, recognizing the necessity of dependable, repeatable practices in non-clinical testing.
These principles span a vast gamut of topics, from guidelines on project management responsibilities and personnel, to quality assurance, facilities, equipment, platforms, standard operating procedures (SOPs), data management, and results reporting. These principles are put forth by a number of standards bodies, including the OECD, FDA, WHO and EMA, which must be adhered to for Good Laboratory Practice compliance.
Both Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations are integrally related to laboratory testing. However, the two categories of regulation are significantly different. Their primary difference is seen in their purpose. Where GMPs are focused on demonstrating adherence to manufacturing criteria, safeguarding the integrity of scientific data, GLP refers to a quality system to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of the data.
As a GMP and GLP laboratory that adheres to Good Laboratory Practice quality controls and procedures, BioAgilytix is centrally focused on preserving the consistency, dependability, reproducibility and integrity of all non-clinical safety testing practices.
At BioAgilytix, our GLP-compliant bioanalytical lifecycle services support clinical and preclinical studies for biologics, anti-drug conjugates, fusion protein, bispecific antibodies, biosimilars, and biobetters.
Our commitment to leveraging Good Laboratory Practices is about far more than regulatory compliance. Good Laboratory Practice is the cornerstone of our promise to uphold the highest levels of quality and integrity in everything we do.
Afshin Safavi, Ph.D., Founder & CSO of BioAgilytix, shares his expert perspectives with Bioanalysis Zone
See how we apply our specialized large molecule expertise to help solve your bioanalytical challenges.
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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 617-456-0700
37 Kent St,Woolloongabba
Queensland, 4102, Australia
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