Richard Wild’s Post

Dive into the phenomenon of Low Endotoxin Recovery (LER) and learn how the ENDO-RS® kit and ENDOLISA® assay play a crucial role in detecting endotoxin interference. 🧪 Download  bioMérieux's  comprehensive case study!

Dive into the phenomenon of Low Endotoxin Recovery (LER) and learn how the ENDO-RS® kit and ENDOLISA® assay play a crucial role in detecting endotoxin interference. 🧪 Download  bioMérieux's  comprehensive case study!

Join us as we dive into the phenomenon of Low Endotoxin Recovery (LER) and learn how the ENDO-RS® kit and ENDOLISA® assay play a crucial role in detecting endotoxin interference. 🧪 Download our comprehensive case study: https://lnkd.in/d95Sh_ih

Like to draw your attention to this webinar where my colleague Alan will review the validation of recombinant methode in #BET testing. #trillium #endotoxin

Equilibrium does not mean equal. When distribution of a drug to a given tissue reaches equilibrium, does it mean that tissue drug concentration (CT) = plasma drug concentration (C)?🤔 No. If tissue binding of a drug is more extensive than plasma protein binding, CT > C, and distribution equilibrium constant Kp > 1 where Kp = CT/C. If the drug crosses the membrane passively with no active transport, do we think its unbound tissue drug concentration (CuT) = unbound plasma drug concentration (Cu)? 🤔 Yes. In this scenario, CuT = Cu, and Kpuu = 1, where Kpuu = CuT/Cu. But what happened to Kpuu if the drug is a substrate of uptake transporter or is a lipophilic basic drug that is sequested within intracellular low pH lysosome? 🤔 Here, CuT > Cu, Kpuu > 1, and at distribution equilibrium, CuT is not equal to Cu! In summary, equilibrium does not mean equal! 😎 I hope you like what I share in this basic #pharmacokinetics #concepts #Season2 #Post29. Do look out for my next posts on PK concepts.   #Pharmacokinetics #Concepts #LearningWithoutBarriers #WeeklyDoseOfPK Unsplash picture by Ouarda Banani.

👋 Are you interested in advanced Oligonucleotide 🧬 Support?! 👋 🔬 Join us in tackling the key challenges faced by oligonucleotide drug developers. With a lack of dedicated regulatory guidelines and varying requirements across regulatory agencies, navigating the CMC landscape can be complex. Additionally, the industry's limited experience in performing complex analytical methods and the need for specialized instrumentation pose further hurdles. At PPD, we offer advanced oligonucleotide support to address these challenges and streamline your development process. ✅ Study Experience 😎: We cover everything from single and double stranded oligonucleotides 🧬 to drug substances and products. Our expertise includes release, stability, method development, validation studies, and dossier submissions. ✅ Method Experience 👨🔬 👩🔬: Our methods cover osmolality, HPLC, assay determination, % nucleic acid encapsulation, sterility, mass ID, particle size analysis, container closure integrity, residual solvent analysis, leachables, elemental impurities, and more. ✅Global Presence 🌎 and Regulatory Expertise 📈 : With two locations including US & Europe, our GMP lab ensures consistent standardized processes, data collection, and quality systems. Our labs meet FDA, EMA (EU) HPRA requirements for commercializing throughout the US and Europe, streamlining the submission process. Our team has extensive regulatory experience, ensuring compliance with global regulations. Message me to learn how we can support your next oligonucleotide program! 📬 #PPD #Oligonucleotide#CMC #AnalyticalScientists #LaboratoryServices #GMPLab

It's not too late to book onto our webinar titled - Endotoxin masking in complex modalities - Wednesday 24th January @2pm-3pm (BST). Led by Callum Dew - AstraZeneca, this informative webinar will cover * Endotoxins, cell wall components of gram-negative bacteria, can represent a problematic contaminant in parenteral formulations * Certain modalities prove to be more problematic than others with regard to establishing a valid endotoxin test * Endotoxin testing must be performed as per pharmacopeia requirement * PDA Technical Report 82 outlines the phenomenon of LER – Low Endotoxin Recovery * LER studies are a requirement of BLA – Biological Licensing Applications * The story so far – troubleshooting endotoxin masking. Describe recent results and observations in complex modalities * Describe future troubleshooting plan Do head to the Pharmig website www.pharmig.org.uk for more information on how to book. You will also see all our other current meetings listed on the left hand side of the home page David Keen Edel Fitzmaurice Anna Lovatt (nee Dinsdale) Tim Sandle, Ph.D., CBiol, FIScT Miriam Guest Mehmet Kerem Davrandi Andy Martin Kim Morwood Alan Moon

Are you looking for reliable detection tools for CAR-T cells? Dextramer® reagents may provide a sensitive solution for direct detection and quantification of CAR-positive cells by flow cytometry, in accordance with the recently updated guidance on CAR-T cell products from the FDA.    Learn more by following the link in the comments!    #CARTTherapy #CellTherapy #Immunotherapy #flowcytometry 

New Application Note A Quick and Efficient Sample Cleanup for Biomolecule Analysis https://lnkd.in/gmFrhsyb A typical example is a monoclonal antibody formulated in histidine as a buffer and containing polysorbate 80 as stabilizer, among other components. We chose to investigate rituximab for this purpose. We looked at how these components interfered with intact protein analysis by liquid chromatography/mass spectrometry (LC/MS), a critical quality attribute. Using LC/MS we observed many of the glycoforms that were present as well as the excipients. But the use of AdvanceBio Spin columns allowed the undesirable components to be eliminated from the analysis. Deglycosylation and subsequent analysis of the released glycans using Gly-X InstantPC labeling enabled a more comprehensive analysis of the glycoforms present. Unfortunately, the histidine buffer contained a primary amine that can also react with the InstantPC reagent. We saw how AdvanceBio Spin columns can be used to perform a simple buffer exchange to an alternative buffer composition that did not interfere with the labeling reaction. 

Thoughts on this? >> Novo Nordisk's oral amycretin could lead to more weight loss beyond 12 weeks, according to early-stage trial >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharma #productmarketing #healthcare #pharmaceutical