Prolytix

We’re beyond excited to introduce our newest member of our QA Team, Lindsey Stinson! Lindsey Stinson is responsible for all things quality assurance as a Quality Assurance Specialist at Prolytix. This includes reviewing and approving QC data prior to release to clients, facilitating CAPA, deviation, and change request processes, and assisting with external and regulatory audits. She is also looking forward to conducting internal audits, providing metrics for management reviews, and assisting in the analysis of trends for opportunities to improve quality processes at Prolytix.   Lindsey has previously worked as a QC Specialist and GMP Application Systems Specialist at Vernal Biosciences. During her time at Vernal, she led the implementation of a LIMS, MES, and ELN and acted as a LIMS administrator. Through this experience, she learned a great deal about project management, data integrity practices, Computer Systems Validation, and the importance of establishing a compliant system from the get-go. Before that, Lindsey worked at Viatris as a Chemist, helping to analyze release, stability, and in-process QC samples. In this role, she developed a solid foundation in GxP regulations, laboratory software, and instrumental analysis techniques.   Lindsey obtained her B.S. in Chemistry at the University of Vermont in 2021. She received the award for Excellence in Analytical Chemistry Award.

We’re pleased to share that our team will be attending the MASSBIO Waltham Regional Mixer at Mighty Squirrel Brewery this Thursday! 🍻   Join us for an evening of great conversations, networking, and of course, fantastic brews. Whether you’re looking to discuss industry trends, explore collaboration opportunities, or just enjoy a pint with us, we’d love to see you there! https://lnkd.in/ePPkmB23 #MASSBIO,#PROLYTIX

🔬 Elevating Quality with Our Lab’s Custom Excipient Testing Services 💊 At Prolytix, we’re passionate about elevating your pharmaceutical products with our cutting-edge excipient testing services! 🚀 Our lab is dedicated to ensuring that every excipient—vital for delivering your active ingredients—meets the highest standards of quality and performance. Here’s how we make a difference: Precision in Physical Properties: From particle size to flowability, we’ve got you covered! Advanced Chemical Analysis: Our chromatography techniques ensure purity and identity are spot on. Dynamic Functional Testing: We assess how excipients impact dissolution and stability to optimize your formulations. Let’s work together to ensure your formulations are not just good, but outstanding! Partner with us for excellence in every test! 🌟   #Pharma #ExcipientTesting #QualityControl #DrugDevelopment #PharmaceuticalLab #ExcellenceInTesting

🎉🎉 Celebrating One Year of Kudos Awards! 🎉🎉   Today marks a fantastic milestone for us as we celebrate one year of recognizing and appreciating the incredible efforts of our team through our Kudos Awards! 🌟👏   Over the past year, we've had the pleasure of witnessing countless acts of excellence, teamwork, and innovation. Our Kudos Awards have become a powerful way to celebrate the hard work and dedication that each of you brings to the table every single day.   A huge thank you to everyone who has participated, nominated, and celebrated with us. Your contributions have made this initiative a success, and we’re excited to continue this journey of recognition and support.   Here’s to many more years of celebrating the outstanding achievements that make our organization shine! 🥂✨ #KudosAwards #EmployeeRecognition #CelebratingSuccess #TeamWork #Anniversary

🎉🎉 Celebrating One Year of Kudos Awards! 🎉🎉   Today marks a fantastic milestone for us as we celebrate one year of recognizing and appreciating the incredible efforts of our team through our Kudos Awards! 🌟👏   Over the past year, we've had the pleasure of witnessing countless acts of excellence, teamwork, and innovation. Our Kudos Awards have become a powerful way to celebrate the hard work and dedication that each of you brings to the table every single day.   A huge thank you to everyone who has participated, nominated, and celebrated with us. Your contributions have made this initiative a success, and we’re excited to continue this journey of recognition and support.   Here’s to many more years of celebrating the outstanding achievements that make our organization shine! 🥂✨ #KudosAwards #EmployeeRecognition #CelebratingSuccess #TeamWork #Anniversary

At Prolytix, our team of scientists excels in tackling our clients' most intricate challenges. We’re excited to share that we’ve recently developed and validated a single method that can simultaneously measure plasma and five distinct tissue matrices. This innovative approach not only streamlines the analysis process but also enhances precision and efficiency. Discover the details behind our latest advancement by reading our new case study: https://lnkd.in/ejUX_nf3 #bioanalysis, #GLP, #Prolytix

We have a new addition to the Prolytix Team: Xin (Cindy) Qi, PhD, CQA, CMQ/OE is joining us as our new Vice President of Quality! Xin (Cindy) Qi is responsible for quality functions as VP of Quality at Prolytix, focusing on providing GxP (GMP, GLP, GCP) analytical testing services to support the development and release of protein therapeutics, as well as the ISO 9001 Quality System supporting Prolytix’s manufacturing activities. Cindy is an accomplished quality professional in Quality Assurance, Quality Control, and Assay Development with a demonstrated history of more than 30 years of experience working in both industrial and academic settings. Cindy brings her extensive experience as an ASQ-certified quality auditor (CQA) and ASQ-certified manager of quality and organizational excellence (CMQOE). Most recently, she served as Senior Director of QC at MassBiologics of UMass Chan Medical School. Before that, Cindy held significant roles of increasing responsibility in different companies, including Beijing Pharmaceutical Company, Abbott, PlateletBio, and Lonza. She has proven track records of directing Quality, Bioanalytical services, and Clinical development, leading to successful partnerships and client retention. Cindy obtained her B.S. in Polymer Chemistry from Peking University and her Ph.D. in Biochemistry, which focused on rewriting the genetic code and RNA/protein engineering, from California Institute of Technology.

We're excited to be launching a new product today: Human D-Dimer! Detectable levels of D-dimer, a fibrin-degradation product, are indicative of significant and on-going blood clotting. We have significant experience measuring D-Dimer in house. Check out D-Dimer: https://lnkd.in/e6B9fCpK To learn more about our analytical capabilities on coagulation testing: https://lnkd.in/eMgzqq-W #ddimer,#Prolytix,#Coagulation,#bioanalytical

Whether your therapy directly treats hemostasis or if you're concerned with off-target coagulation effects, Prolytix has been a trusted provider for evaluating Hemostatic Risk for over 20 years.   In concert with our Thrombin Generation Assay (TGA), we can run additional methods to identify the potential of a drug candidate to negatively impact the coagulation system. Check out all of our assays supporting hemostatic risk here: https://lnkd.in/didu3_vn #Coagulation; #TGA; #Prolytix

GMP stability and release testing for large-molecule biopharmaceuticals and proteinaceous In Vitro Diagnostic (IVD) reagents are challenging due to the complex nature of these products and the stringent requirements for their use in clinical settings. Due to this complexity, it is essential to partner with a bioanalytical CRO like Prolytix that offers sophisticated analytical techniques to fully characterize each molecule and ensure batch-to-batch consistency.   A new blog post delves into GMP stability and release testing challenges for large-molecule drugs and the services Prolytix offers to address these challenges. Read more: https://lnkd.in/ekMCisnN John Moriarity #GMPStabilityTesting #GMPReleaseTesting #BionalyticalCRO