PPD™ Laboratory Services’ Post

Polymerase chain reaction (PCR)-based bioanalytical testing is the cornerstone of evaluating delivery, safety and efficacy of cell and gene therapies. Learn more about reducing regulatory risks in this evolving field. » https://bit.ly/41bblBt #bioanalyticaltesting #cellandgenetherapies #PCRassays

Through fortunate and often dramatic and heartbreaking encounters in my life I learned first hand the life saving value of the cell & gene therapies. This is the reason I am sharing the link to the amazing course run by the talented Melody Janssen. Share this, forward to the people you know who work in this field. It may help them to arrive sooner to the place where more puzzles will be solved and more lives saved. #cell #genetherapy #life #learning #bioanalytics

As advancements of life-saving therapies like cell and gene progress, new approvals could be on the horizon. Our experts, Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line and Cori Gorman of Biopharma Excellence chatted about navigating the different and sometimes contradictory regulatory requirements in the US and EU. Read the piece: https://ow.ly/I0bH50QwzwA

Interesting read on the future of CGT!

Demand for #advancedtherapies, such as cell and gene therapies, is growing and won’t stop anytime soon. To get these innovative treatments to patients as quickly as possible, it is critical for #CDMOs to evolve to meet the needs of #pharma and #biotech customers as they work to move medicines from #clinicaltrials to commercialization.   I recently had the opportunity to sit down with [@Clinical Trials Arena] to discuss how our newly opened cold and ultra-cold facility in the #Netherlands will enable our partners in the EU to advance medicines.    Read more from our conversation here: https://lnkd.in/e9j3Rs2e

𝑭𝑫𝑨 𝑮𝒓𝒂𝒏𝒕𝒔 𝑭𝒂𝒔𝒕 𝑻𝒓𝒂𝒄𝒌 𝑫𝒆𝒔𝒊𝒈𝒏𝒂𝒕𝒊𝒐𝒏 𝒕𝒐 𝑩𝒂𝒚𝒆𝒓 𝒂𝒏𝒅 𝑨𝒔𝒌𝑩𝒊𝒐'𝒔 𝑮𝒆𝒏𝒆 𝑻𝒉𝒆𝒓𝒂𝒑𝒚 𝒇𝒐𝒓 𝑷𝒂𝒓𝒌𝒊𝒏𝒔𝒐𝒏’𝒔 𝑫𝒊𝒔𝒆𝒂𝒔𝒆  Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio) announceD that the FDA has granted Fast Track Designation for AB-1005, a promising gene therapy for moderate Parkinson’s disease. AB-1005 also received the Innovation Passport from the UK MHRA. 🌍 AB-1005, an investigational AAV2-GDNF neurorestorative gene therapy, is making strides in treating moderate Parkinson’s disease. Earlier this year, AskBio shared positive 18-month Phase Ib clinical trial results, achieving the primary goal of evaluating the safety of a one-time bilateral delivery directly to the putamen.💡 https://lnkd.in/dvya45vz AskBio is hiring for a Clinical Trial Manager (Remote) https://lnkd.in/d74TtC8D #GeneTherapy #ParkinsonsDisease #Innovation

📝🎓(Bio) Analytics of Cell and Gene Therapies | 20 & 21 May 2024 | Short Online Course |£316 when you register before 24 April (20% saving) This training course will provide you with a deep-dive insight into how cell and gene therapy products are clinically developed and manufactured. Once completed you will be aware of the types of assays needed to assess pharmacokinetics, immunogenicity and potency. You will also examine the regulatory expectations around assay validation. Learn more about the course - https://buff.ly/3UyEKnQ #educolifesciences #cellandgene #CGT #ATMP #bioanalytics #PK #immunogenicity #celltherapy #training

𝐂𝐞𝐥𝐥 𝐚𝐧𝐝 𝐠𝐞𝐧𝐞 𝐭𝐡𝐞𝐫𝐚𝐩𝐲 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐭𝐨𝐩 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐭𝐫𝐞𝐧𝐝 𝐟𝐨𝐫 𝐩𝐡𝐚𝐫𝐦𝐚 𝐢𝐧 𝟐𝟎𝟐𝟒 Healthcare industry professionals scored cell and gene therapy (CGT) as the industry trend to have the greatest impact on the pharmaceutical industry in 2024, in a recent survey launched by GlobalData, a data and analytics company. The survey data presented in “The State of the Biopharmaceutical Industry 2024” report reveals that N=21 (18%) of industry professionals were convinced that CGT will dominate as the most important trend in pharma next year. This was followed by personalized/precision medicine (N=18 respondents; 16%). Source Info: https://lnkd.in/dHp3AdkX

Are you working in Cell and Gene Therapy, using CRISPR, AAV vectors, and mRNA Therapeutics? These innovations require rigorous molecular analyses and adherence to regulated guidelines for bioanalysis and safety testing, including biodistribution, pharmacokinetics, transgene expression, and shedding throughout the developmental stages of therapies so a #GLP accredited #CRO is what you need! #research #aav #cellandgenetherapy #medicine #lifesciences

Plasmid DNA (#pDNA) is used in #genetherapies, vaccines, and #RNAtherapeutics. Along each step of development, we need to evaluate potential impurities. In this new Cell & Gene article, Brian Glass of Pharmatech Associates, a USP company delves into potential testing methods for pDNA to evaluate its suitability for therapeutic applications. https://lnkd.in/edA7JPsk #DNA #drugdevelopment #drugmanufacturing #cellandgenetherapies