Abzena’s Post

Curious about Abzena's new, high-producing cell line development platforms- AbZelect™ & AbZelectPRO™? Check out our latest blog to find out how our unique CLD platforms are increasing efficiencies while reducing risks and costs for early-phase biologic and bioconjugate drug programs.

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

Calling #Biologics,#biosimilar,#Biotech companies to register for upcoming workshop on Key Trends for #RegulatoryAffairs in #ANVISA by Leandro Lozano Consultant Regstart & Former #Registry Analyst #ANVISA. Learn #Regulatorypathways in #Biological drugs Focus on #biosimilar requirements: #Physicochemical aspects #Nonclinical development #Clinicaldevelopment.

Quantify #protein, measure molecular weight, and detect aggregates by Stunner. Stunner combines UV/Vis, Rotating Angle DLS (RADLS) and Multi-Angle Light Scattering (#MALS) to provide precise results and helps in biologics development. Get rid of sample dilution, cuvette-based methods, costly dyes and standard curves. Achieve high-throughput screening with low sample volumes in no time. Check out the application note for details- #AbsorptionSpectroscopy #quantification #therapeutics #pharmaindustry #biologics #bioanalytical #DynamicLightScattering #lifescience #biologics #mabs #proteomics

Concerned about mRNA-LNP integrity during international shipping? Strategic partners, Crystal Bio and CATUG, combined efforts to evaluate the effects of mRNA-LNP integrity during international shipping to compare data between shipping sites for: 🔹 Size with distribution 🔹 Encapsulation 🔹 Purity For more information, visit: https://lnkd.in/eHEb33rN #CrystalBio #CATUGCrystal #CrystalPharmatech #CATUG #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO

It’s good to dig in the myth regarding international shipping of mRNA-LNP samples, as the sample integrity did not seem to be affected by temperature (within 2 days without cold control) but could be afftected with additional chance of shaking/bumping. A more thorough study will be conducted for better improvement (eg, package the sample with better fixed conditions).

#ICYMI: Our latest blog features a comprehensive exploration by our team of scientific experts into Chemistry, Manufacturing, and Controls (CMC) analytical control strategies. This edition provides insights into the pivotal role of CMC in drug development, along with an in-depth analysis of the diverse analytical testing strategies essential for appropriate manufacturing control of advanced therapeutics. Learn More https://bit.ly/49E9CZ7 #CMC #BioAgilytix #PotencyAssays #PCR #Flowcytometry #lcms #Genetherapy #Biologics #ATMP

Each drug's unique biochemistry calls for a tailored approach. We understand that biotech companies face challenges like stability, aggregation, and interaction with excipients. Paired with a biophysical approach that provides greater accuracy in predictions, the Tanvex platform stands out by predicting potential hurdles and enabling rapid, informed decision-making. Read how Tanvex CDMO is revolutionizing formulation development and contributing to the accelerated timelines of drug development in Pawel Stanczak's article: https://lnkd.in/eVuKyqjH #biologics #cdmo #pharmaindustry #lifesciences

Watch the short video to learn more about how WuXi XDC offers you an unprecedented single-source approach for ADC/Bioconjugate discovery, development and manufacturing.