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Celerion
Pharmaceutical Manufacturing
Lincoln, NE 20,312 followers
Celerion Can Take You from First-In-Human through Proof-of-Concept.
About us
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
- Website
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http://www.celerion.com
External link for Celerion
- Industry
- Pharmaceutical Manufacturing
- Company size
- 1,001-5,000 employees
- Headquarters
- Lincoln, NE
- Type
- Privately Held
- Founded
- 2010
- Specialties
- Applied Translational Medicine, Global Clinical Research (Phase I and II, NDA-enabling clinical pharmacology), Data Management and Biometrics, Global Bioanalytical Services (discovery through late phase), Drug Development Services, and Global Clinical Development
Locations
Employees at Celerion
Updates
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The T wave is an integral component of the QT interval, an important cardiac safety proarrhythmic risk assessment in drug development. Identifying T wave abnormalities and determining their significance can impact critical aspects of a clinical trial, including participant enrollment, dosing decisions, adverse event reporting, and the need for specialist referrals, as well as QT analysis and interpretation. Our comprehensive tutorial summarizes T wave pathophysiology, etiology, and natural history, coupled with specific T wave morphology illustrations and its role in nonclinical and clinical drug development. Read now: https://lnkd.in/eXuS8wRu #TQT #Twave #ECGcorelab
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Learn about our experience, expertise and efficiencies we have put in place to support drug development for novel GLP-1 therapies and weight reduction drugs. Read now: https://lnkd.in/d-aw5b7D Also, don’t miss our recent blog article on obesity drug development: https://lnkd.in/envwd63z #GLP1 #DrugDevelopment #WeightReduction
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Celerion’s Regulatory Affairs experts have extensive IND authorship, submission, and management experience to relieve you of this vital yet complex and labor-intensive process. Check out our full regulatory & scientific affairs support services: https://lnkd.in/e-sCYGCk #RegulatoryExcellence #PharmaRegulations #RegulatoryAffairs #DrugDevelopment
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Radiolabeled “Absorption, Distribution, Metabolism, and Excretion” (ADME) studies help understand how organisms handle a candidate drug. While in most cases, nonclinical ADME data from animal models predict clinical excretion routes, in some cases drug metabolism and excretion routes are substantially different - highlighting the relevance of conducting human ADME studies. Learn more: https://lnkd.in/eKtSQmaR https://lnkd.in/e8Hk8bdE #ADME #ADMEStudies #drugmetabolism
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LC-MS/MS is a mature technology in Bioanalysis and is often referred to as a commodity. This may be true as it is available in many laboratories around the world. However, with today’s complex new modalities, highly challenging small molecules, peptides, and oligonucleotides, the challenges in developing LC-MS/MS assays are greater than ever. At Celerion, we’ve been doing LC-MS/MS analysis in our laboratories since 1992. We have a long history of innovations and experience with challenging projects. For instance, we have performed bioanalysis of peptides and oligonucleotides for over 20 years. The complex small molecules, such as protein degraders and biomarkers, often require close collaboration with our on-site clinics for proper sample collection or our LBA and Flow Cytometry teams for associated biomarker analysis. In the case of ADC’s you get all of your complex bioanalysis under one roof with one set of management. Even the traditional small molecules are smaller, stickier, less stable, and nonpolar. All challenges that a lab with experience must address. Learn more about Celerion's Bioanalytical Services: https://lnkd.in/e94Jchx #Bioanalysis #LCMSMS #Peptides #Oligonucleotides #SmallMolecules #DrugDevelopment #PharmaResearch
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Join Celerion in South San Francisco for our "Summer Sip & Mingle" Networking Event! Connect with industry peers, enjoy cocktails and appetizers, and engage in meaningful conversations with leaders in clinical research and bioanalysis. Date: Wednesday, July 30, 2025 Time: 5:00–7:30 PM Location: The Hangar, Upstairs Camber Terrace, 460 Forbes Blvd, South San Francisco, CA ✨ Featured Conversations: ▪️ AI and automation in early-phase research ▪️ Innovations in combination study design ▪️ Biomarker strategies and FDA guidance ▪️ Integrated clinic and lab approaches …and more! Meet the Experts: Dr. Chad Briscoe, Dr. Michelle Combs, and Amer Nasic will be on-site to share insights and connect with attendees. Space is limited! RSVP by July 22 to: Aricia Pfaff at aricia.pfaff@celerion.com or SUMMER JENSEN at summer.jensen@celerion.com (limited to professionals in biotech/pharma companies) We look forward to seeing you there! #ClinicalResearch #NetworkingEvent #Bioanalysis #ClinicalPharmacology #BayAreaBiotech #PharmaNetworking #EarlyPhaseResearch #CRO
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Automation is transforming the future of bioanalysis. Are you ready? Chad Briscoe, Executive Vice President of Bioanalytical Sciences at Celerion, recently shared how Celerion is leveraging automation to deliver faster, more consistent, and higher-quality data for early clinical research. From 18 fully utilized robots in our Zurich lab to seamless data integration through our proprietary ClinQuik system, automation is no longer a future goal—it’s a standard our clients expect. -2x–6x increase in throughput -Near real-time data delivery -Over 500,000 samples processed annually -Same-day processing for time-sensitive assays like flow cytometry Whether it's LC-MSMS, ligand binding, PCR, or flow cytometry—automation is enabling our teams to focus on what matters most: innovation, quality, and patient impact. Watch the full interview to see how Celerion is redefining bioanalytical CRO operations: https://lnkd.in/ePr_4ASA #Celerion #Automation #BioanalyticalScience #ClinicalResearch #InnovationInBiotech #PharmaLeadership #LabAutomation #EarlyPhaseResearch
Revolutionizing Bioanalytical Labs: Chad Briscoe on Automation at Celerion
https://www.youtube.com/
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Heading to AAPS Summer Scientific Forum in Indianapolis? Join Celerion for an evening of networking, golf, and great conversation at Five Iron Golf – Indianapolis: Tuesday, July 15 | 6:30 – 9:30 PM 421 N. Pennsylvania St. Suite 101, Indianapolis, IN 46204 -Connect with leaders in clinical research and bioanalysis -Learn more about our innovative work -Unwind in a fun, interactive setting RSVP to John Haug at john.haug@celerion.com. Spots are limited—reserve yours today! While you're at AAPS SSF, don’t miss Soumya Mohana Sundaram, Associate Director, Ligand Binding, Bioanalytical Services, at Celeron, sharing insights on advancing ADA assays and adapting to emerging technologies: Wednesday, July 16 at 10:55 AM – Overcoming Drug Interference in Anti-Drug Antibody (ADA) Assay Wednesday, July 16 at 11:10 AM – Building for Change: Technologies, Modalities (Panel Discussion) We can’t wait to connect with you in Indy! Learn more about AAPS SSF: https://www.aaps.org/ssf #AAPS2025 #NetworkingEvent #Bioanalysis #ADA #ClinicalResearch #PharmaEvents #Celerion #FiveIronGolf #ClinicalPharmacology #DrugDevelopment
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Celerion pharmacies co-located in our clinical pharmacology units are USP <795>, <797>, <800>, <1163>, and <1168> compliant, as well as following the FDA Guidance on cGMP for Phase 1. We offer sterile, non-sterile, and ADME compounding. We have experience with all forms of drug preparations, including API in capsules, oral solutions, suspensions, and sprinkles, as well as topical, injectable, and inhaled dosage forms. Learn about the benefits of onsite pharmaceutical compounding: https://lnkd.in/d9nMNTQ #clinical #pharmacology #pharmaceutical
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