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Author: Scientific Office

Answers to Your Questions on Immunogenicity Testing for Biosimilars: Part 2

BioAgilytix’s Todd Lester answers additional questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.

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Questions on Immunogenicity Testing for Biosimilars Answered: Part 1

BioAgilytix’s Todd Lester answers questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.

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Bioanalytical Testing Under GMP: Assuring Biologic Safety & Efficacy via Impurities Assays

We discuss the need to put phase-appropriate methods in place to identify and quantify both process- and host-cell related impurities throughout the drug development process.

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Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices

BioAgilytix has been fortunate enough to have several of our team members participate as co-authors on all three AAPS white papers in the series on…

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A Dose of Pharma and Biotech News: December 12, 2019

With innovative research driving pharmaceutical and biotech breakthroughs, industry progress is accelerating at a rapid pace. We've compiled some recent industry articles on the latest…

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Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

Cell-based bioassays are expected by health agencies as one of the release specification methods for potency assessments in the drug development process. We take a…

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BioAgilytix Team Q&A: Meet Tatjana Ackermann, Quality Assurance Auditor

We strive to foster an environment where our team members can continually grow within their role and within the company – not only upwards, but…

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CRISPR-Cas9 Milestones: The First In Vivo Clinical Trial Is Now Underway in Boston

The first in-human in vivo clinical trial using CRISPR-Cas9 is now open for enrollment; we take a closer look at this genome editing technology to…

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BioAgilytix Team Q&A: Meet Janett Schwarz, Principal Investigator at BioAgilytix

In our latest Team Q&A, we talk to Janett Schwarz, Principal Investigator at BioAgilytix’s European headquarters, about how her role has evolved since joining our…

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Event Line-Up: The Bioanalytical Industry Forums We’ll Be at This Fall

We're looking forward to participating in several upcoming bioanalytical conferences and events this fall, ranging from small-circle workshops to global, world-renowned industry forums.

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