Yokogawa Fluence Analytics’ Post

The implementation of continuous processing in the biopharmaceutical industry is hindered by the scarcity of process analytical technologies (PAT). To monitor and control a continuous process, PAT tools will be crucial to measure real-time product quality attributes such as protein aggregation. Marcel Ottens and other co-authors at Delft University of Technology in The Netherlands implemented the micromixer in a lab-scale integrated system for the purification of mAbs, established in an ÄKTA™ unit. A viral inactivation and two polishing steps were reproduced, sending a sample of the product pool after each phase directly to the microfluidic sensor for aggregate detection. An additional UV sensor was connected after the micromixer and an increase in its signal would indicate that aggregates were present in the sample. The at-line miniaturized PAT tool provides a fast aggregation measurement, under 10 min, enabling better process understanding and control. #biologics #antibody #antibodies #antibodytherapeutics #mab #mabs #cmc #continuousmanufacturing #processdevelopment #processanalytics

An interesting concept to improve the downstream process development

Check out our newest blog post!

GEM FORLAB S.r.L. wants to share another #CaseStudy 📝 👨🔬 This time we will talk about #IVD (In vitro diagnostic). If you want to know more, scroll through the slides! #gemforlab #ablebiosciences #medtech #pharmaceutical #research #healthcare #proteomics #GLP #molecularbiology #chemistry #biotechnology #ivdr #medicaldevice #medicaldevices #IVDRvalidation #testfacility #dispositivimedici Find out more on gemforlab.com

#XTT and #MTT assays for cell viability are colorimetric-based assays that function to evaluate cell #proliferation and #viability on microplate readers. GEM FORLAB S.r.L. is performing this test following GLP and ISO 10993-5 guidelines. Find out more on gemforlab.com #gemforlab #medtech #pharmaceutical #research #healthcare #proteomics #molecularbiology #chemistry #GLP

Innovations in Prefilled Biologics, full article here:https://lnkd.in/eh8cAUir Prefilled products, particularly prefilled biologics, are a growing sector in the pharmaceutical industry. “Prefilled syringes and pens offer precise dosing, reducing the risk of errors during administration. They also eliminate the need for reconstitution, making them more convenient for patients and healthcare professionals,” explains Ward Smith, director of marketing and business development at Keystone Folding Box Company, a manufacturer of paperboard packaging. Prefilling also improves product/patient safety because less handling means less chance of contamination. Primary packaging developments include ready-to-use (RTU) containers and designs to address higher viscosity products, larger syringe volumes to meet the dosing requirements of longer-acting biologics, cryogenic storage and distribution, greater focus on self-administration and patient comfort, and container enhancements that minimize the risk of product/package interactions. “This minimized interaction risk ensures that the biologics maintain their efficacy and safety profiles,” says Van Ginneken. With sensitive substances and challenging environmental requirements, biologics place special demands on primary and secondary packaging. Many APIs are light-sensitive, and the large, complex molecules in many new molecular entities are sensitive to oxygen. Cell and gene therapies as well as messenger RNA (mRNA) substances must be stored and transported at extremely low temperatures. Thus, syringe development has focused on designs capable of withstanding low-temperature conditions without losing functionality or container closure integrity. One example, the TOPPAC freeze prefilled syringe from SCHOTT Pharma, is designed for drugs that require storage and transport at temperatures approaching -100 °C. Another option from SCHOTT Pharma, EVERIC freeze vials, are available in sizes from 2–30 mL and can be supplied RTU. Strength-optimized geometry, designed into the structure of the vials, reduces the risk of breakage (2). Thanks to Ward Smith Tom Van Ginneken Daniel Martinez Zubieta Corinna Endres Justin Schroeder Deborah Smook Keystone Folding Box Co. SCHOTT Pharma Stevanato Group Schreiner MediPharm L.P. PCI Pharma Services TurboFil Packaging Machines thanks also to Hallie Forcinio and Pharmaceutical Technology #pharmamanufacturing #aseptic #syringe #drugpackaging #biologics #bioprecessing #biopharmaceutical #ampoule #sut

Paras Biopharma Fc-Fusion scale-up development, including Biologics & Biosimilar (Fc-Fusion for ITP), is mainly facilitated by advanced Paras Biopharma technologies, including Cytofold StructQuant®, (to facilitate disulphide and folded active product) & cell line engineering knowledge.    Paras Biopharma’s Technology Development of Cytofold StructQuant®, Biomultifold®, NobelCleav® enables to achieve high expression production clone, highest titres and production, resulting into low cost of goods (COG). We accomplish scale-up production in an efficient and consistent manner.   The Paras Biopharma team looks forward to successfully providing scale-up production services for your Biologics scFv / Fab / Nanobodies and medicinal and for other Enzymes and complex Fusion Protein projects.   #technologies #ITP #biologics #scFv #Fab #Nanobodies #Enzymes #fusionprotein #development #production #biosimilar

𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐨𝐟 𝐂𝐨𝐧𝐜𝐞𝐧𝐭𝐫𝐚𝐭𝐢𝐧𝐠 𝐚𝐧𝐝 𝐔𝐥𝐭𝐫𝐚-𝐇𝐢𝐠𝐡 𝐂𝐨𝐧𝐜𝐞𝐧𝐭𝐫𝐚𝐭𝐢𝐧𝐠 𝐏𝐫𝐨𝐭𝐞𝐢𝐧 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐭𝐨 𝐈𝐦𝐩𝐫𝐨𝐯𝐞 𝐭𝐡𝐞 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐄𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞 𝐚𝐧𝐝 𝐑𝐞𝐝𝐮𝐜𝐞 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐂𝐨𝐬𝐭 By investing in formulation development and novel approaches, manufacturers can unlock the benefits of high concentration protein therapeutics, ultimately improving the patient experience and reducing manufacturing costs. Read the full article by Anthony Stewart, Process Engineer at Kymanox, here: https://lnkd.in/ed2NfaQf Learn more about how we can support you. Follow Kymanox: https://lnkd.in/e35y_dQq #proteintherapeutics

Nanocrystals and nanosuspensions: an exploration from classic formulations to advanced drug delivery systems Nanocrystals and nanosuspensions have become realistic approaches to overcome the formulation challenges of poorly water-soluble drugs. They also represent a less-known but versatile platform for multiple therapeutic applications. They can be integrated into a broad spectrum of drug delivery systems including tablets, hydrogels, microneedles, microparticles, or even functionalized liposomes. The recent progresses, challenges, and opportunities in this field are gathered originally together with an informative case study concerning an itraconazole nanosuspension-in-hydrogel formulation.  #Nanocrystals #Nanosuspensions #Pharmaceutical #Formulation

Empower early assets’ development in a scientific way.