Unlocking the Future of Gene and Cell Therapy with Pharmaron’s CGT Safety Assessment Services At Pharmaron, we’re at the forefront of revolutionizing gene and cell therapy (CGT) with our specialized safety assessment services. Our team brings unparalleled expertise and experience, ensuring that our partners’ CGT products meet the highest safety standards. Our comprehensive CGT Safety Assessment includes: - In vitro and in vivo safety evaluations tailored to your project needs - Advanced genetic toxicology and immunogenicity assessments - Customized study designs to support regulatory submissions - End-to-end support from our highly experienced team members With Pharmaron’s state-of-the-art cGMP biomanufacturing facility and our commitment to excellence, we are your trusted partner in bringing innovative therapies to market. Connect with us to learn more about how our CGT Safety Assessment services: https://lnkd.in/eA4WSZrm #GeneTherapy #CellTherapy #CGT #SafetyAssessment #Pharmaron #Biomanufacturing #Biotech
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Prices for the 5th Gene Therapy Immunogenicity Summit increase at midnight tonight, so here are 3 reasons why you should take advantage of discounts of up to $850 today: 👥 4 New Deep-Dive Workshops: providing in-depth discussions into immunoassays, immunosuppression, translational models, and redosing to enhance your end-to-end immunogenicity approach, led by experts at Novartis, AbbVie, Tenaya Therapeutics, and Adolore Biotherapeutics. 📑 6 New Case Studies: Hear from leading pharmaceutical companies on the most pressing immunogenicity challenges, including new data on transgene-specific immunogenicity from Regeneron and Roche to pinpoint the exact causes of adverse immune responses to improve immunogenicity prediction. 🤝 Network with a Highly Curated Audience: Engage in meaningful and in-depth interactions, ask questions, and share your insights with senior experts in bioanalytics, immunosuppression, toxicology, pharmacology, and more. So what are you waiting for? Claim your discount on the official event website today: https://ter.li/mxp3gp
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|| CAR T || Viral vectors || Assay development || Cell line development || cGMP || CAR T analytics || FACS || CGT || CAR T Regulatory ||
The latest FDA guidance on CAR T cell products: a valuable resource for individuals in the field of Cell and Gene Therapy (CGT), offering specific recommendations for manufacturing, control (CMC), toxicology, and clinical study design. This comprehensive document caters to both autologous and allogeneic CAR T cell therapies, providing a solid framework for those involved in the field. The guidance also extend to other genetically modified lymphocytes, such as CAR NK cells or TCR modified T cells, making it a versatile and inclusive resource for the broader spectrum of genetically modified cell therapies. While the guidance lays out a robust framework, it is crucial to acknowledge the differences between the FDA and EMA recommendations, especially regarding regulatory approaches. The EMA places a strong emphasis on risk assessment and safety, requiring comprehensive data on product characterization, toxicology studies, and post-marketing surveillance. In contrast, the FDA may exhibit a more agile approval process but remains equally rigorous in evaluating aspects of CMC and clinical study design. Navigating these distinctions is essential for researchers and practitioners in the CGT field to ensure compliance with both FDA and EMA regulations, contributing to the development and approval of safe and effective cell therapies. #cartcelltherapy #genetherapy #fdaregulations #fdacompliance
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AGC Biologics' Giuliana Vallanti, VP of Global R&D, and Alessandra Gatti, Cell Process Development Director, helped co-author an article about hematopoietic stem cell gene therapy for treating mucopolysaccharidosis type II. The study demonstrated the therapy's efficacy in restoring IDS activity, reducing neurotoxicity, and improving motor skills in mice. The treatment also showed promising results in long-term survival and behavioral assessments. These findings offer a clinically viable solution for multisystemic mucopolysaccharidosis type II. Read the full article to learn how these findings can be applied for future applications in clinical settings. https://lnkd.in/gQBKE4xm #biotech #pharma #Biopharma #pharmaceuticals #LifeScience #Biotechnology #advancedtherapies #Biopharmaceuticals #AGCBio #CDMO
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The OTP was established in March 2023 to deal with the ever-increasing pace of cell and gene therapies. It is the first super office at #CBER, with six sub-offices, 14 divisions and 33 branches. This brings the #FDA’s total number of super offices to three. The creation of such an office brings with it structural changes that should improve discipline alignment, increase review capacity and enhance expertise. #genetherapy #cellandgenetherapy #regulatoryaffairs #weknowregulatory
FDA’s OTP Super Office on Track to Fill 500 Positions | BioSpace
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Philadelphia Cell and Gene Therapy Conference hosts FDA officials - The Philadelphia Inquirer >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharma #competitivemarketing #healthcare #pharmaceutical
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Founder & CEO PharmaPro Consulting ✦ Clinical pharmacology ✦ Pharmacometrics ✦ Regulatory Affairs ✦ Entrepreneur💥
FDA has issued a new guidance that assists sponsors in developing Chimeric Antigen Receptor (CAR) T cell products, a form of human gene therapy. It covers recommendations on chemistry, manufacturing, control (CMC), pharmacology, toxicology, and clinical study design, with specific notes for autologous or allogeneic CAR-T cell products. Analytical comparability studies are also addressed. This guidance, while tailored for CAR-T cell therapy products, offers applicable insights for other genetically modified lymphocyte products like CAR Natural Killer cells or T cell receptor modified T cells. #CAR-T #GeneTherapy #FDAGuidance #cmc #clinicalpharmacology #fda #pharmaproconsulting To learn more use the link below: https://lnkd.in/gJZ3aGBX
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Delivery systems are key components in pharmaceutical product development including new generations of gene therapies, cancer treatments, and vaccines. Microfluidizer® technology achieves a small, uniform particle on the nanoscale. Particle size is a key factor in influencing absorption, content uniformity and shelf-life. Microfluidics differentiates itself from its competition in its unparalleled ability to achieve superior, repeatable results with seamless, linear scale up capabilities. Whether a drug delivery platform is being used for therapeutic or vaccine development, scale up (to commercial distribution with similar results as R&D) is critical. Microfluidizer® technology is centered on achieving identical results no matter the volume – from benchtop to pilot scale to production scale. For an in-depth look at the various drug delivery systems and Microfluidics' role in manufacturing them, read more: https://hubs.la/Q01J6G3f0 #drugdeliverysystems #drugdeliverymanufacturing #drugdeliveryproduction #drugdelivery #nanoemulsions
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Exegenesis Bio to Present 9-Patient Data from a Phase 1/2 Clinical Trial of EXG001-037, a Novel rAAV Gene Therapy ... - Yahoo Finance >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #competitivemarketing #pharmaceutical #biotech #pharma #healthcare
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Thoughts on this? >> Exegenesis Bio to Present 9-Patient Data from a Phase 1/2 Clinical Trial of EXG001-037, a Novel rAAV Gene Therapy ... - Yahoo Finance >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #healthcare #competitivemarketing #biotech
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🧬What are the 5 key differences between developing Cell & Gene Therapies in the United States vs European Union? While 'traditional' drug categories like small molecules have long-standing similarities, for cell and gene therapies (CGTs) and other complex biologics, the regulatory processes in the United States and European Union vary considerably. This ebook from Thermo Fisher Scientific (summarised in the video below by PharmaSource) explains the 5 key differences to be aware of: 1️⃣ Terminology: Biologics in the US vs Advanced Therapy Medicinal Products (ATMPs) in the EU 2️⃣ Guidance documents and governing regulations 3️⃣ Regulatory interaction and approval Pathways 4️⃣ Manufacturing expectations, inspection processes + documentation 5️⃣ Commercialisation requirements with shorter approval timelines Over time, we hope regulators may converge on harmonised expectations. But for now, download this ebook! https://lnkd.in/eNGRNfPQ #cellandgenetherapy #atmp
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