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BioAgilytix Demonstrates Expanded GMP Analytical Capacity One Year After Strategic Investment in Morrisville
As advanced therapeutics continue to accelerate toward the clinic, the demand for robust, GMP-ready analytical testing support has intensified. The Morrisville and Hamburg expansions were designed to help sponsors address increasing complexity in testing, in order to provide manufacturing support and regulatory readiness.
The expansion established dedicated GMP QC laboratory infrastructure and strengthened BioAgilytix’s ability to support GMP analytical testing programs. Today, that investment is enabling clients to advance programs with greater confidence, consistency and readiness across all phases and commercialization.
Over the past year, BioAgilytix has continued to support clients across a range of modalities, where analytical rigor and regulatory expectations are rapidly evolving. By aligning GMP testing activities with validation, lot release and stability requirements, the company is helping reduce variability, support compliant decision-making during tech transfer and improve overall program readiness.
“The pace of innovation in advanced therapeutics is creating new pressure on analytical strategies,” said Paul Blalock, who recently joined BioAgilytix to lead the continued growth of its GMP testing services. “Our focus is on helping sponsors move forward with confidence, ensuring their analytical methods are not only scientifically sound, but also ready to withstand regulatory scrutiny as they progress.”
The Morrisville facility provides a range of GMP testing services; including a state-of-the-art biochemistry lab supporting product characterization testing and expanded bioassay capability, within a globally aligned infrastructure that enables consistency across BioAgilytix’ s U.S., and European laboratories.
This continued expansion reflects the growing need for scalable, integrated GMP testing solutions that can keep pace with increasingly clinical pipeline and evolving regulatory expectations.
“Analytical readiness is no longer a downstream consideration. It’s a critical component of overall program success,” Blalock added. “We’re continuing to invest in the infrastructure and expertise needed to support that shift.”
BioAgilytix remains focused on advancing its GMP testing capabilities to meet the evolving needs of its global client base, with ongoing investments in technology, capacity, and scientific leadership.
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About BioAgilytix
BioAgilytix is a leading global bioanalytical laboratory providing established and innovative bioanalytical services to pharmaceutical and biotechnology companies. With laboratories in North America, Europe, and Australia, BioAgilytix supports programs from discovery through late-stage clinical development with expertise in pharmacokinetics (PK), immunogenicity, biomarkers, GMP testing and Analytical services.
Noelle Brawner
BioAgilytix LLC
+1 2026746190
email us here
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