TA Instruments’ Post

NEW White Paper | Risk-Based E&L Strategies for Bioprocessing Single-Use Systems. Navigating USP<655>/<1665>, BPOG & other guidance for safe & effective biologics ⬇️ This white paper delves into the risks due to leachables associated with bioprocessing single-use systems and explores risk-based strategies for their mitigation. We will navigate the evolving regulatory landscape and explore best practices for extractables and leachables (E&L) testing. Download our white paper now to get the knowledge you need to ensure the safety and quality of your biopharmaceutical products in the era of single-use technology: https://lnkd.in/ecd_EeX5 #ExtractablesAndLeachables #SingleUseSystems #biologics #biopharmaceuticals

Sterility assessments are critical for ensuring the safety and efficacy of pharmaceutical products. Read the first installment of the Crystal Bio Whitepaper Series to learn about components of the safety evaluation process for drug manufacturing. For more information, visit: https://lnkd.in/eng_Ui-N #CrystalBio #CrystalPharmatech #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO

Safety and efficacy are the 2 major criteria / concerns for agencies like FDA to license a drug for approval as well as for marketing drugs. Among the 2, safety is the #1 concern. Anything out of spec in sterility test will be the major red flag for safety concern. This is a good article to go through the sterility assessments, as a first in the series. Stay tune for more later.

Excited about accelerating the development process of your #biologics from molecule to patient? This e-book discusses the top challenges that emerging biologics face. Discover innovative containment solutions and strategies to drive your product’s journey from lab to patient! https://bit.ly/3AFEkEm #Biopharma #DrugDevelopment

White Paper | Risk-Based E&L Strategies for Bioprocessing Single-Use Systems. Navigating USP<655>/<1665>, BPOG & other guidance for safe & effective biologics ⬇️ This white paper delves into the risks due to leachables associated with bioprocessing single-use systems and explores risk-based strategies for their mitigation. We will navigate the evolving regulatory landscape and explore best practices for extractables and leachables (E&L) testing. Download our white paper now to get the knowledge you need to ensure the safety and quality of your biopharmaceutical products in the era of single-use technology: https://lnkd.in/ecd_EeX5 #extractables #leachables #biologics #biopharmaceuticals #SingleUseSystems

🌟 New ebook from Single Use Support: Filling gaps in managing large volumes of biologics Aseptic aliquotation and cryopreservation of bulk drug substances are crucial process steps in bioprocessing that require an efficient process. Find out more below 👇 #Bioprocessing #Biologics

Are you looking to expedite your drug development process while maintaining the highest standards of data quality and analysis? In our latest blog, we interviewed our Sr. Scientific Leader for Analytical Development, Dr Eric Miller, to learn how our innovative LabZient™ analytical platform is transforming the landscape of data analysis for biopharmaceuticals. From platform benefits to real-world scenarios, he delves deeper into the capabilities and impact of this cutting-edge platform and how it can streamline and de-risk the pathway to IND and beyond. Access the blog here: https://lnkd.in/g-rcUn9p #CDMO #CRO #Biologics #Analyticalmethoddevelopment

Are you interested in intensifying your biologics manufacturing process? 👩🔬 👨🔬 📈 Join us for an exclusive webinar delving into the building of an innovative integrated continuous downstream manufacturing platform in the production of biologics. Discover how next-gen manufacturing is shaping the future with cost-effective solutions and increased productivity. Register now and gain valuable insights from the experts including Irina Ramos, Elizabeth Goodrich, Kurt Boenning and Paul Gillham! 💡 💡 💡 https://lnkd.in/eWGDCjRA #pharma #biologics #webinar #PAT #downstreamprocessing #continuousprocessing #productivity

With a 30-year history in biologics and pharmaceutical services, CRDMO Syngene is now primed to offer integrated drug discovery and development services across modalities. Discover why we are the preferred partner to more than 450 companies around the globe for drug substances, drug products, clinical development, and commercial manufacturing. 👉To book a meeting with our experts, click on the link in the comments. DCAT (Drug, Chemical & Associated Technologies Association) #DCATWeek #smallmolecule #drugsubstance #drugproduct #biologics