Gerresheimer’s Post

Searchable database for biological products - FDA Purple Book. https://lnkd.in/gZY3x3Zh The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products. The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER). #fdaapproval #purplebook #biologics #cder #cber #biosimilars #genetherapy #vaccines #interchangeable

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The tenth edition of AscellaHealth’s digital newsletter, Specialty Pharmaceutical Pulse™ is out!   This issue features essential approaches to overcoming the challenges of clinical trials for specialty drugs & cell and gene therapies and clinical advancements being made in the treatment for Psoriasis.   To read the latest issue and subscribe to future editions, see below or link in comments.   Read more: https://lnkd.in/ehtGi73H   #specialtypharmacy #raredisease #pharmaceutical #genetherapy #psoriasis

🔬 Navigating the intricate landscape of cellular and gene therapy products consists of many challenges. The FDA's latest guidance offers new considerations for sponsors of INDs and applicants of BLAs in the realm of CGT products. 🧬 ✨ With a comprehensive approach to product comparability and manufacturing change management, this guidance sparks a new chapter in the evolution of CGT products. 💡 Let's explore the key highlights: - 🔄 Adopting a lifecycle-based strategy for managing manufacturing changes - 📊 Conducting comparability studies to ensure product quality remains consistent Read the draft guidance on the FDA website: https://lnkd.in/gXrvumQx #CellularTherapy #GeneTherapy #FDAInsights #Biologics #ProductComparability #ManufacturingExcellence #LifeSciences #Innovation #MedicalAdvancements #Healthcare #Biotech #ResearchMatters #FDAGuidance #RegulatoryCompliance #QualityAssurance

How can we improve clinical trial methods for the advancements in cell and gene therapy? Find answers to these questions and more by joining Matthew Spear, M.D. and others in a roundtable discussion at our Immuno-Oncology Roundtable Xchange happening in #SanDiego February 27th 2024. For more information, agendas and to register, please visit https://lnkd.in/eF5AHSKD Please note: Registration is only open to Senior Scientists and above actively working in the #pharmaceutical / #biotech industry. Each roundtable is limited to 8 participants. #hubXchangeNotAConference #pharma #biotech #bigdata #datasciences #lifesciences #drugdevelopment #pharmacology #genomics #pharmaceutical #immunotherapy #immunooncology #therapies #oncology #biomarkers #celltherapies #immune #biochemistry

https://bit.ly/44Rv7Ec - Read the Article here Effect of Enterococin – Zinc Oxide Nanoparticles on Gene Expression of rsbA Swarming Genes in Proteus mirabilis isolation Catheter urine. University of Diyala #BLIS #Pmirabilis #rpoA #rsbA #ZnONPs #Biomedical #Pharmacology #Medicines #Pharmaceuticals #medicalresearch #biopharma #health #ospcjournals #peerreview #openaccessjournal

Silicone-oil-free Syringe Systems: Addressing the needs of next generation drug molecules - With the rise of new and sophisticated therapeutics drug technologies such as RNAi or AAV-based gene therapies silicone-oil can be an issue and cause unwanted interactions of drug molecules, carrier/vector molecules and the prefilled syringe. To minimize risks related to silicone-oil in ready-to-fill syringes made of glass or polymer and support those new approaches along their journey to market approval, we are proud to announce our new silicone-oil-free syringe systems ensuring excellent container closure integrity, also during deep-cold storage, as well as superb break-loose and gliding forces over shelf-life. -Available in Polymer (COP) & Glass, 1.0 ml long and 0.5 ml -Luer Lock configurations available as complete silicone-oil-free options, excluding silicone-oil within all used components -Our syringe systems can be configurated with two stopper variants (PFAS-free option available) -Suitable for ophthalmics, RNAi, mRNA, gene therapies and sensitive molecules Comprehensive testing data regarding performance and functionality available. Learn more about: https://lnkd.in/eVfJ6UQS #innovatingforabetterlife #ophthalmic #syringes #pharma #biotech

How can we improve clinical trial methods for the advancements in cell and gene therapy? Find answers to these questions and more by joining Matthew Spear, M.D. and others in a roundtable discussion at our Immuno-Oncology Roundtable Xchange happening in #SanDiego February 27th 2024. For more information, agendas and to register, please visit https://lnkd.in/ej3wRkkv Please note: Registration is only open to Senior Scientists and above actively working in the #pharmaceutical / #biotech industry. Each roundtable is limited to 8 participants. #hubXchangeNotAConference #pharma #biotech #bigdata #datasciences #lifesciences #drugdevelopment #pharmacology #genomics #pharmaceutical #immunotherapy #immunooncology #therapies #oncology #biomarkers #celltherapies #immune #biochemistry

On 1st April 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene Therapy Products. The updates mainly involved the Risk Management Plans (RMP), Safety Notification to HSA and submission of Periodic Benefit-Risk Evaluation Report (PBRER). More details can be found in the link in the first comment. #pharma #pharmacovigilance #pharmaceuticalindustry #HSA

How can we improve clinical trial methods for the advancements in cell and gene therapy? Find answers to these questions and more by joining Matthew Spear, M.D. and others in a roundtable discussion at our Immuno-Oncology Roundtable Xchange happening in #SanDiego February 27th 2024. For more information, agendas and to register, please visit https://lnkd.in/eRab_BEE Please note: Registration is only open to Senior Scientists and above actively working in the #pharmaceutical / #biotech industry. Each roundtable is limited to 8 participants. #hubXchangeNotAConference #pharma #biotech #bigdata #datasciences #lifesciences #drugdevelopment #pharmacology #genomics #pharmaceutical #immunotherapy #immunooncology #therapies #oncology #biomarkers #celltherapies #immune #biochemistry