Science versus Compliance? https://lnkd.in/edHMTx9n "Working in the pharmaceutical industry, you can sometimes hear science and compliance talked about as if they are separate and unrelated." - What do you think? Take a look at this article by Paul Mason and let us know in the comments! #Bioequivalence #Biologics #Biosimilars #Compliance #Generics #RegulatoryAffairs #Validation
Good information. Thanks for sharing.
Host cell proteins (HCP) are impurities present in all therapeutics derived from biological sources, but due to product safety and efficacy risks ⚠️, a drug product's overall quantity of residual and high-risk HCPs is a critical quality attribute (CQA) that must be characterized and controlled 🔍 throughout the manufacturing process. Explore our Innovation Spotlight 💡 for a closer look into how your organization can approach a HCP control strategy with #ProtaGene. 👇 #biopharma #biologics
🧠 How could you deliver your drug product to the brain? 👃 Have you considered the nose as a potential route of administration? "An integral part of developing dry powder biologics for nasal delivery is in the device selection and testing of the delivered dose to ensure maximum delivery of the biologic into the correct areas of the nasal geometry." Discover more about the opportunities and challenges of developing dry powder biologics for nasal delivery in our latest whitepaper by Richard Johnson. Download to learn more 🔽 https://lnkd.in/gUuU2mtb #CDMO #Whitepaper #Biologics
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).
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
🛫𝐄𝐧𝐬𝐮𝐫𝐢𝐧𝐠 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐢𝐧 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐒𝐡𝐢𝐩𝐩𝐢𝐧𝐠 𝐨𝐟 𝐦𝐑𝐍𝐀-𝐋𝐍𝐏🛬 Dear customers, we understand how critical it is to maintain the integrity of mRNA-LNP samples during international shipping, and we are pleased to share recent data from our partner, Crystal Bio, a member of Crystal Pharmatech , which confirms the stability of key quality attributes across three different samples generated at our facilities in China and travelled all the way to the US (New Jersey). 𝐇𝐞𝐫𝐞 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐟𝐢𝐧𝐝𝐢𝐧𝐠𝐬 𝐚𝐟𝐭𝐞𝐫 𝟑 𝐝𝐚𝐲𝐬 𝐨𝐟 𝐭𝐫𝐚𝐧𝐬𝐢𝐭: ✨Purity (%): Remains unaffected by international shipping, ensuring that samples arrive in optimal condition. ✨Size: Only minor changes were observed, with particle size remaining within acceptable range. ✨Encapsulation Efficiency (EE%): Slight variation in EE% was noted, but the overall encapsulation remained consistent. Altogether, these results assure that your mRNA-LNP products will retain their quality, even after a long travel and behave as expected once delivered to you!
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
Check out this practical checklist for emerging biotechs on the importance of selecting packaging components!
Navigating the complexities of packaging systems can make or break your drug launch. At a loss for where to start? Look no further: our article discloses five key factors to consider for your injectable drug product and emphasizes the importance of thoughtful packaging selection. Check it out now: https://bit.ly/3MXwqcg #biopharma #drugdevelopment #Biologics
Principal, Regulatory Affairs, Combination Products at West Pharmaceutical Services
Check out this practical checklist for emerging biotechs on the importance of selecting packaging components!
Navigating the complexities of packaging systems can make or break your drug launch. At a loss for where to start? Look no further: our article discloses five key factors to consider for your injectable drug product and emphasizes the importance of thoughtful packaging selection. Check it out now: https://bit.ly/3MXwqcg #biopharma #drugdevelopment #Biologics
Navigating the regulatory landscape can be one of the most significant hurdles in biologic development, making a robust regulatory strategy essential. At Abzena, our experts can deliver regulatory guidance and packages tailored to you and your molecule. Based on our decades of regulatory experience, we will provide the best strategy for your molecule, regardless of its phase. Learn more about how we can provide regulatory support for your next biologic or bioconjugate project here: https://lnkd.in/dn82MHc3 #Biologics #CDMO #Pharma #regulatory
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
With 40+ clients' products currently in clinical trials, we have extensive experience to optimize your clinical bioconjugation process. We focus on process improvements in： √ higher productivity, lower CoGs √ product quality consistency √ process robustness and scalibility √ security of supply Contact us to discuss your needs: https://lnkd.in/gPPyFxjH #bioconjugation #biomanufacturing #biopharma #biologics #biotherapeutics #ADC #antibodydrugconjugate #ADCs #antibodydrugconjugates #BioconjugationProcessDevelopment #ProcessDevelopment
Protein A is the darling of downstream unit operations for the manufacture of monoclonal antibodies. Its numerous advantages far outweighs its disadvantages and dispite its high cost it has become the resin of choice for the initial capture step in the purification platform for Mabs. Abzena’s platform for Mabs includes Protein A as the capture step. Other affinity resins are now available if the product of interest is not a Mab. Affinity chromatography has come a long way since the introduction of protein A. To find out more take a few minutes to read the article attached. Stay healthy and well Abzena
Abzena's SVP of Science & Technology, Dr Parviz A. Shamlou was recently featured in Pharmaceutical Technology's latest eBook discussing affinity ligands and their role in the future of downstream processing for complex biologic programs. Access the article here: https://lnkd.in/eUZkaV6F #CDMO #ligands #drugdevelopment #biologics #thoughtleadership
President & Principal Consultant - Pharmaceutical Microbiologist, Manufacturing & Lab Compliance Senior Consultant to GMP Regulated Industries at Russo Consulting Group, LLC
2moGreat points. In the world of microbiology control, whether much of the “new” science is “good” or “otherwise” has been being hashed out for decades, and in many cases there are legitimate arguments for two or more “best practices” based upon the existing science. In a regulated industry and at the end of the day, in situations like these, complying with these policies should be paramount to firms while disagreements on what the “best” science is, for a given application and purpose). Some scientific technologies are “superior” than others, but depending on the intended requirements of its use, an alternate technology might be more preferable for one or more reasons.