We are fully equipped and prepared to handle your pre-filled syringe (PFS) and cartridge filling project using cutting-edge technology and seamless technology transfer. Our advanced, flexible, high-speed filling lines are capable of producing millions of doses of sterile products, including biologics and biosimilars, to support your unique project. Discover more about our state-of-the-art PFS capabilities: https://lnkd.in/eWYDFZHJ #PFS #PFC #Fillfinish #Biologics
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🌐💡Analytics Innovation for Biologics and CGT (NBE, Biosimilars, Cellular and Gene Therapies, RNA, Peptides, etc.) 🚀🔬
𝐁𝐢𝐨𝐥𝐨𝐠𝐢𝐜𝐬 𝐒𝐭𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐒𝐭𝐮𝐝𝐢𝐞𝐬: 𝐊𝐞𝐲 𝐭𝐨 𝐒𝐮𝐜𝐜𝐞𝐬𝐬 Stability studies ensure your biologic maintains its quality, safety, and efficacy. ️ At ProtaGene, we have a proven track record in implementing them for biosimilars & biologics. Let's discuss your development journey! [email protected] #biologics #stabilitystudies #biopharmaceutical
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Meticulous characterization from candidate selection to QC testing is vital for #biopharmaceutical developments. Discover how ProtaGene thoroughly generates all data 📊 needed for your product's characterization: https://bit.ly/3SL5rmK #Biologics #CRO
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Sensitive drug products and #biologics often require specialized processing steps. Lyophilization (freeze-drying) is a proven, comprehensive approach for preserving the long-term stability of many complex formulations. 💉 🧊🥽 In this technically demanding process, customization is key. Learn how we implement, customize, and manage the lyophilization process for vial-based injectable therapies on our website: https://lnkd.in/e4XZbtdz From lab scale to full production, we’re able to deliver fully customized lyophilization solutions at scale. Have a project that could benefit from our lyophilization expertise? Get in touch to discuss how we can support you. #lyophilization #pharmaceuticals #drugdevelopment #stability #CDMO
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Vice President External Affairs, Vetter Pharma / Past Chair, International Board of Directors, ISPE
And this is how automated lyophilizer loading is done, in full accordance with Annex 1.
Sensitive drug products and #biologics often require specialized processing steps. Lyophilization (freeze-drying) is a proven, comprehensive approach for preserving the long-term stability of many complex formulations. 💉 🧊🥽 In this technically demanding process, customization is key. Learn how we implement, customize, and manage the lyophilization process for vial-based injectable therapies on our website: https://lnkd.in/e4XZbtdz From lab scale to full production, we’re able to deliver fully customized lyophilization solutions at scale. Have a project that could benefit from our lyophilization expertise? Get in touch to discuss how we can support you. #lyophilization #pharmaceuticals #drugdevelopment #stability #CDMO
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Sterility assessments are critical for ensuring the safety and efficacy of pharmaceutical products. Read the first installment of the Crystal Bio Whitepaper Series to learn about components of the safety evaluation process for drug manufacturing. For more information, visit: https://lnkd.in/eng_Ui-N #CrystalBio #CrystalPharmatech #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Applying Advanced Analytical Methods to Recombinant Biologics, Cell and Gene Therapies
Looking to get ahead on your QC Timelines with Top Tier characterization? We can get your projects started immediately! Shoot me a quick message and set up a meeting as early as next week with our experts. Enjoy the long weekend 😁 #ProtaGene #QC #Characterization
Meticulous characterization from candidate selection to QC testing is vital for #biopharmaceutical developments. Discover how ProtaGene thoroughly generates all data 📊 needed for your product's characterization: https://bit.ly/3SL5rmK #Biologics #CRO
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Safety and efficacy are the 2 major criteria / concerns for agencies like FDA to license a drug for approval as well as for marketing drugs. Among the 2, safety is the #1 concern. Anything out of spec in sterility test will be the major red flag for safety concern. This is a good article to go through the sterility assessments, as a first in the series. Stay tune for more later.
Sterility assessments are critical for ensuring the safety and efficacy of pharmaceutical products. Read the first installment of the Crystal Bio Whitepaper Series to learn about components of the safety evaluation process for drug manufacturing. For more information, visit: https://lnkd.in/eng_Ui-N #CrystalBio #CrystalPharmatech #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Learn from Cardinal Health Regulatory Sciences experts on biologics license applications (BLA) including designation types, submission best practices, the FDA process, next steps, and more. Visit the link below! 🔗 https://lnkd.in/gku9p4eG #cardinalhealth #lifesciences #biologics #BLA #FDA
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New video! Watch this captivating short video of WuXi Biologics’ expansive drug product development capabilities. Our single-source and state-of-the-art services range from biologics formulation development of liquid, frozen and lyophilized dosage forms through to drug product fill development of multiple container closure systems (CCSs) including vials and combination products like prefilled syringes and autoinjectors. After you view the video – get more information here: https://lnkd.in/eUQJugYB #drugproduct #bioprocess #biologics #biopharma #biopharmaceuticals
New video! Watch this captivating short video of WuXi Biologics’ expansive drug product development capabilities. Our single-source and state-of-the-art services range from biologics formulation development of liquid, frozen and lyophilized dosage forms through to drug product fill development of multiple container closure systems (CCSs) including vials and combination products like prefilled syringes and autoinjectors. After you view the video – get more information here: https://lnkd.in/eUQJugYB #drugproduct #bioprocess #biologics #biopharma #biopharmaceuticals
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Amidst surging demand and global disruptions, it's crucial to ensure resilient supply chains for vital medications. https://lnkd.in/ezzkUJgz Check out our latest blog post to discover how innovative manufacturing approaches are addressing these challenges head-on. Click the link to read more and stay ahead in the pharmaceutical industry! #Biologics #Medications #SupplyChain #Innovation
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