Attending the American Association of Pharmaceutical Scientists (AAPS) | aapscomms Summer Scientific Forum in Kansas City? Don’t miss the Rapid-Fire presentation by BioAgilytix’s Manoj Kumar Baskaran where Manoj will discuss the potential impact of the draft FDA guidance on potency assay strategies for cell and gene therapies. BioAgilytix has supported over 150 GMP validations/qualifications of potency assays in nearly every biologic modality since 2018. Visit our team of experts onsite at booth 8 to discuss your biologic and ATMP CMC testing questions or needs. https://bit.ly/3We9g72 #immunogenicity #celltherapy #genetherapy #cellandgenetherapy #CMC #PCR #flowcytometry #ASOs #biotherapeutics #biopharma
BioAgilytix
Biotechnology Research
Durham, NC 28,406 followers
Enabling the breakthroughs of tomorrow, today.
About us
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory. BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
- Website
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http://www.BioAgilytix.com
External link for BioAgilytix
- Industry
- Biotechnology Research
- Company size
- 1,001-5,000 employees
- Headquarters
- Durham, NC
- Type
- Privately Held
- Founded
- 2008
- Specialties
- Immunoassays, Cell-Based Assays, Immunogenicity, Pharmacokinetics, Biomarkers, Large molecule bioanalysis, Bioanalytical testing, Assay Development & Validation, Bioassays, Biosimilars, Gene Therapy, and Immuno-oncology
Locations
Employees at BioAgilytix
Updates
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We are gearing up for another exciting annual American Association of Pharmaceutical Scientists (AAPS) | aapscomms Summer Scientific Forum in Kansas City. On July 24th Bryan M. Gullick, Ph.D. will present “Validation Best Practices: PCR Case Studies in Shedding” at 2:35 pm. Our scientific team has a deep level of experience with developing, optimizing, and validating complex molecular assays using qPCR or ddPCR. We take a collaborative approach, leveraging our molecular expertise to ensure your project is a success. Visit our website to learn more and schedule a meeting onsite at booth 8 with our team of experts to discuss your PCR project needs. https://bit.ly/3We9g72 #immunogenicity #celltherapy #genetherapy #cellandgenetherapy #CMC #PCR #flowcytometry #ASOs #biotherapeutics #biopharma
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Manoj Kumar Baskaran will present at the upcoming American Association of Pharmaceutical Scientists (AAPS) | aapscomms Summer Scientific Forum on the transfer and validation of a flow cytometry assay across platforms and labs. Did you know BioAgilytix can support flow cytometry readouts for assays under non-regulated or regulated (GCLP, CLIA, and GMP) conditions, utilizing a variety of flow cytometry platforms? Our flow cytometry laboratories are staffed with experienced scientific teams that routinely develop assays to support drug development programs across a range of endpoints and applications. Visit our website to learn more about our flow cytometry assay experience and schedule a meeting with our experts onsite at booth 8 in Kansas City. https://bit.ly/3We9g72 #immunogenicity #celltherapy #genetherapy #cellandgenetherapy #CMC #PCR #flowcytometry #ASOs #biotherapeutics #biopharma
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We are getting excited for the American Association of Pharmaceutical Scientists (AAPS) | aapscomms! Don’t miss @AmandaHays's presentation, where she will highlight the potential challenges associated with bioanalytical method transfers and provide case studies with strategies for overcoming these potential hurdles during the method transfer phase. As a CRO with extensive experience in this space, BioAgilytix has implemented procedures and practices to mitigate these risks and to support successful transfers both internally and externally. Learn more about our strategies for successful method transfers by scheduling a meeting with our team of experts onsite at booth 8. https://bit.ly/3We9g72 #immunogenicity #celltherapy #genetherapy #cellandgenetherapy #CMC #PCR #flowcytometry #ASOs #biotherapeutics #biopharma
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Andrea Sequeira will present “Bioanalytical Strategies for Immunogenicity Assessment of ASOs” during the American Association of Pharmaceutical Scientists (AAPS) | @aapscomms Summer Scientific Forum. Her presentation will outline the challenges in measuring anti-drug antibody (ADA) responses to ASOs and provide strategies that can be used to ensure the ADA assays meet regulatory expectations. Visit our website to schedule a meeting at booth 8 with our experts to discuss your immunogenicity project. https://bit.ly/3We9g72 #immunogenicity #celltherapy #genetherapy #cellandgenetherapy #CMC #PCR #flowcytometry #ASOs #biotherapeutics #biopharma
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BioAgilytix is hiring a Lab System Support Specialist in Durham! This role involves providing both remote and on-site IT support for lab systems, configuring lab systems, troubleshooting IT issues, and supporting corporate infrastructure projects and validated computerized systems. As a Specialist III we are looking for someone with a minimum of 5+ years of IT experience in a GxP environment. The ideal candidate will be proficient with computing hardware, software, data cabling, networking protocols, and desktop support, and have experience with a variety of laboratory systems and platforms. Apply now and be part of our innovative IT team! https://bit.ly/3XKs3In #BioAgilytix #Hiring #ITcareers
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We are looking forward to American Association of Pharmaceutical Scientists (AAPS) | aapscomms Summer Scientific Forum in Kansas City. Visit booth 8 to speak with our experts about your PK, immunogenicity, biomarker, and CMC assay requirements so we can provide you with the clear results you need to progress your project. Be sure to attend the presentations by our team of experts. Amanda Hays, PhD Hays- Strategies for Overcoming Challenges with Bioanalytical Method Transfers Andrea Sequeira - Bioanalytical Strategies for Immunogenicity Assessment of ASOs Manoj Kumar Baskaran- Implications of Draft FDA Guidance on Potency Assays for G&CT Bryan M. Gullick, Ph.D.-Validation Best Practices: PCR Case Studies in Shedding Manoj Kumar Baskaran- Transfer and Validation of Flow Cytometry Assay Across Platforms and Labs Visit our website to schedule a meeting with our team onsite: https://bit.ly/3We9g72 #immunogenicity #celltherapy #genetherapy #cellandgenetherapy #CMC #PCR #flowcytometry #ASOs #biotherapeutics #biopharma
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Are you attending the #ACROConnect ACRO Workshop to learn more about CMC development? Don’t miss Gopit Shah, PhD's presentation, where he will explore ligand binding assay applications for protein analysis across the drug development pathway, from early phase to late phase programs. Learn more about BioAgilytix CMC bioanalytical services:https://bit.ly/4a0eV5G #LigandBindingAssay #CMC #immunogenicity #biomarker #pharmacokinetics #PK #cmcanalyticaldevelopment
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Don't miss the newest episode of the Molecular Moments podcast! In this episode, our Chief Scientific Officer, Jim McNally speaks with our new CEO, Davide Molho DVM, to discuss his first 100 days at #BioAgilytix, the current state of the biotech and pharma industry, and the need for innovation and prioritization in drug development. https://bit.ly/4c6KqeJ #bioanalysis #drugdevelopment#biotherapeutics #LifeSciences #Pharma#Podcast #clinicalresearch
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Our team was recently onsite at the Medicon Valley Alliance Good Morning Meeting in Copenhagen, Denmark presenting on the topic of addressing the complexities of immunogenicity testing. We were honored to be joined by Director, Clinical Pharmacology & Bioanalysis of Ascendis Pharma, Susanne Pihl on stage during the session. We had a lot of insightful discussions about recent developments in immunogenicity testing including ADA domain specificity assessments along with experimental and regulatory requirements. We always enjoy opportunities to meet face-to-face with clients and share our learnings in the field. Learn more about our immunogenicity services here: https://bit.ly/4b6hbHY #immunogenicity #biotherapeutics #biopharma #InnovationInScience