Join us at the AAPS Summer Scientific Forum in Kansas City, MO & attend our session, “Practical Approaches to Characterizing Charged Variants”. Connect with our analytical experts at booth #5 during the event. See you there! #analyticaltesting #GMP #biologics https://ow.ly/YR2W50St8Yl
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20 year's experience has generated strong scientific support for interchangeability of biosimilars approved according to standards set by major regulatory authorities such as #FDA and #ema. This statement from US-FDA is fully aligned with our statement from April 2023 (https://lnkd.in/d9Fkqmk5) underpinning that biosimilars offers an alternative that are equally safe and effective as their reference counterparts
CDER’s recent research takes the Spotlight! 🌟 Check out the latest Spotlight on CDER Science, which highlights research that examined the safety aspects of switching between reference #biologics and #biosimilars: https://lnkd.in/d2s2EtHU
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CDER’s recent research takes the Spotlight! 🌟 Check out the latest Spotlight on CDER Science, which highlights research that examined the safety aspects of switching between reference #biologics and #biosimilars: https://lnkd.in/d2s2EtHU
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We thoroughly enjoyed the #biologics 2024 Panel Discussion on industry trends in oligonucleotide discovery & development. Some interesting discussions around dealing with published patent applications. Thank you to everyone involved! Oxford Global
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CDER’s recent research takes the Spotlight! 🌟 Check out the latest Spotlight on CDER Science, which highlights research that examined the safety aspects of switching between reference #biologics and #biosimilars: https://lnkd.in/d2s2EtHU
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Want to find out how to achieve a more uniform drug antibody ratio (DAR) profile and stable attachment for your #ADC? Attend our live webinar this Wednesday, March 27th, to learn how from our #bioconjugation experts Petra Dieterich, DPhil, MBA, and Nicolas Camper. They will share insights into design and development strategies for bioconjugates & ADCs and delve into the impactful role of linker technologies in accelerating and de-risking the development process to IND and beyond. Register here: https://lnkd.in/g6W_cUiK #CDMO #CRO #biologics #drugdevelopment #drugsubstance
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We're heading to Barcelona in a few weeks for CHPI and can't wait to meet with you! Schedule a meeting with our team of experts or find us at Stand 3H20 to discover how BIOVECTRA can best support your upcoming projects. Our team is available to discuss your most complex challenges including: - Biologics and available capacity at our microbial fermentation suites - Our pDNA, mRNA, and LNP manufacturing capabilities and state-of-the-art process development and biomanufacturing facilities - Synthetic small molecules - Bioreagents - Highly potent APIs Our unique, custom systems are designed to deliver solutions quickly and efficiently and our extensive regulatory expertise is backed by long-standing relationships with major regulatory bodies. Schedule time with us today! https://ow.ly/KLzA50PGyFm #CPHIBarcelona #CPHI #CPhIWorldwide #CDMO #HPAPIs #biologics #pDNA #mRNA #fermentation #syntheticsmallmolecules #bioreagents #MPEGs #synthesis #complexchemistry #biomanufacturing #lifesciences #biosciences #therapeutics #fillfinish
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Scale up your industry knowledge at the European Biomanufacturing Summit on 10-11 September 2024 in Berlin, Germany. Immerse yourself with over 120 biomanufacturing experts in lively discussions on biomanufacturing #cellandgene #biologics and #biosimilars, along with many other core discussions in the industry. Stay at the forefront of industry trends and connect with top innovators in the #biomanufacturing industry https://hubs.ly/Q02C1N8k0 #BioEU24 #GenerisBIOEU
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Ready to revolutionize your #biosafety protocols with #NGS-based assays? Detecting adventitious agents (AAs) in #biologics can be challenging. Traditional methods can take days to months, but with Next-Generation Sequencing (NGS), the nucleic acid content of various AAs can be rapidly identified. The challenge? Analyzing the vast amount of data produced. Enter Genedata, an end-to-end enterprise software that provides a full solution, from analyzing raw reads to creating standardized and comprehensive assay reports. Our platform is 21 CFR Part 11 compliant and supports Computerized System Validation (#CSV) for NGS systems within #GMP environments. Discover how Genedata simplifies the process of analyzing NGS data while ensuring compliance with regulatory standards! https://buff.ly/4c3ZLNP #DigitalizingBiopharma #GenedataSelector #drugdevelopment #Bioinformatics
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It’s good to see the analytical approaches to assess CQA under regulatory guidance.
Assessment of CQA in mRNA-LNP modality is essential to ensure product quality. They can influence: 🔹 Potency 🔹 Stability 🔹 Toxicity 🔹 Risk assessment relevant to mRNA-LNP modality This white paper is the first of a 3-part series written in partnership with CATUG. Stay tuned to learn more about ADC’s and mAb’s later in this series. For more information, visit: https://lnkd.in/eeg42_hj #CrystalBio #CATUGCrystal #CrystalPharmatech #CATUG #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Recently, we announced our big news: Tentamus Pharma UK acquired MALDI-TOF technology. Since then, we have received lots of inquiries about Pharmaceutical Microbial Identification testing and how our service using MALDI-TOF technology can help you comply with the updates to Annex 1 in 2023. Here are some frequently asked questions (FAQs) along with their responses: 🟢 What is MALDI-TOF technology? MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight) is a powerful analytical technique used for the rapid and accurate identification of microorganisms. It uses an ultraviolet laser to irradiate samples embedded in a matrix, inducing the acceleration of proteins and peptides. This acceleration enables them to travel towards the detector at a speed dependent on their mass. Subsequently, this speed is translated into an exact molecular mass, which is then compared with an internal database of microorganisms. 🟢 What are the benefits of using MALDI-TOF for microbial identification? Our in-house MALDI-TOF equipment allows us to provide our clients with several advantages, including rapid results and fast turnaround times, high accuracy and broad applicability across different types of microorganisms. 🟢 Can the MALDI-TOF service help us comply with the new updates to Annex 1 in 2023? Yes. With this service, there are flexible options for results to be delivered within a span of a few days, with high accuracy on a wide range of microorganisms. This particularly meets the latest update to EudraLex Annex 1, stating that enumeration is no longer enough; organisms need to be identified. Please feel free to message us at HelloUK@tentamus.com to learn more about it! #MicrobialIdentification #MALDITOF #Pharmaceutical #Testing #Annex1 #Tentamus
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