Drew Hope’s Post

Here is a great piece highlighting the crucial role of preservation equipment in CGT research! 👏 Good work Kenan Moss! #PHCbi #weprotectscience #CellAndGeneTherapy #CGT #Biotech #LifeSciences #GeneTherapy #CellTherapy #Biopharma #BiotechResearch #CGTInnovation #ColdChain

Another example of a key player (Editas Medicine) in the ATMP space pivoting toward in vivo gene editing and away from conventional ex vivo gene editing. This is a potential disruptor to conventional gene-engineered cell therapies, particularly considering the implication to costs, accessibilitly and manufacturing times. #geneediting #genetherapy #invivo #exvivo.

In cell and gene therapy, like other biotech areas, meeting strict regulatory standards is crucial. How you manage your cryopreservation process matters. To ensure quality and compliance, it's vital to have solid data management strategies. The FDA requires thorough record-keeping, including maintaining electronic records. Using automation with built-in data management helps maintain these standards, ensuring reliable research outcomes. Effective data management is an important trend in cryopreservation. Interested in staying updated on other cryopreservation trends? Read about them here: https://hubs.ly/Q02ty2BR0 #Cryopreservation #Automation #SampleManagement #CryoTrends

The cell and gene therapy (CGT) market is set to skyrocket, but navigating its challenges, especially in product preservation, is critical. Traditional liquid nitrogen freezers come with significant risks and costs. Mechanical freezers are emerging as a safer, more efficient alternative, crucial for protecting fragile, high-value CGT products and driving innovation. Read the full article written by Kenan Moss, Cell & Gene Therapy Application Specialist with PHC Corporation of North America here: https://lnkd.in/eFnd4jrt #CellAndGeneTherapy #CGT #Biotech #LifeSciences #GeneTherapy #CellTherapy #Biopharma #BiotechResearch #CGTInnovation

The limitations of plasmid DNA in AAV manufacturing are a bottleneck for gene therapy applications. Touchlight's enzymatically synthesised dbDNA™ overcomes these hurdles, offering a high-fidelity, safer, and more efficient alternative. Read one of our newest articles, "Transforming the Economics of AAV Manufacture While Optimizing Quality with dbDNA" to discover how Touchlight is paving the way for safer and more efficient gene therapy manufacturing: Tom Merritt #biotechnology #pharma #biotech #genetherapy #dbDNA

Maintaining paper-based records, although a deeply rooted practice in manufacturing, can negatively impact the overall efficiency of the site, especially in CGT operations where delivery times are short and data accuracy is paramount. Implementing an MES, such as the MODA-ES® Platform, not only eliminates manual errors but also accelerates production timelines. With the added ability to perform open phase parallel processing, the site’s manufacturing capacity expands without any additional overhead costs. To learn more about the MODA-ES® Platform deployment project at our four CGT manufacturing sites, watch our webinar ‘Digitizing Cell and Gene Therapies Manufacturing - A Lonza Case Study ”.

Cell and Gene Therapy (CGT) manufacturing is undeniably complex, with many variables! 💡 Design of Experiments (DoE) unlocks the design space-driving efficiencies through speed, cost-effectiveness, optimization throughput and predictive power. How? Traditional one factor at a time (OFAT) involves adjusting one variable while keeping others fixed. A time-intensive and sequential process until an optimal combination is found. 💡 DoE evaluates multiple variables simultaneously using various statistical techniques. Get to the key parameters that influence your outputs faster ✔ This means evaluating complex interactions between the various manufacturing inputs to optimize for desired outcomes—functional titer, impurity, genomic titer, quality, and even cost reduction—all at once! Now imagine what you can achieve by combining the statistical power of DoE with High-Throughput Virology! At Virica, we do just that! 👉 Check out our latest read on how Virica leverages DoE to optimize CGT manufacturing optimization rapidly and efficiently! Interested in learning more? Reach out to us through our website https://lnkd.in/gD4g8f94 or send us a DM on LinkedIn! #biomanufacturing #DOE #innovation #cgtreads

Our quality-by-design HEK293 Ignition Cells™ and pEMBR™ Ad Helper Plasmid allow us to deliver more efficient services to gene therapy developers. Here's how 👇 Ignition Cells™: • Applicable across a wide variety of indications, serotypes, and stages of development • Well-documented history with regulatory feedback • Fully qualified Master Cell Bank and Working Cell Bank produced at Forge • >90% full capsid post-enrichment with CsCl, with undetectable empty particles • Used by >95% of clients pEMBR™ Ad Helper Plasmid: • Immediately available at research and phase I/II GMP-Pathway grades • Shows equivalent AAV yields as compared to commercially available alternatives • Improved safety profile, engineered to reduce known immunogenic elements • Decreased size increases efficiency in manufacturing • Used by >80% of clients

As the field of gene therapy advances, we're seeing exciting developments but also new hurdles to overcome. This virtual event will dive deep into the latest breakthroughs and challenges in cell and gene therapies, with expert-led discussions on safety, manufacturing, and cost-effectiveness. Register today and don't miss the opportunity to hear from top industry leaders as they address the key issues shaping the future of advanced therapies. #CellandGene #CellandGeneTherapy #GeneTherapy #CGT #Manufacturing #Safety #AdvancedTherapies #CarT #SuppyChain #Reimburesment #PatientsFirst #Technology #Regulatory #Innovation #Biotech #Pharma #CellTherapies #AdvancedTreatments #BiotechInnovation #HealthcareLeadership #MedicalAdvances #Biopharma #FutureOfMedicine #TherapeuticBreakthroughs #PharmaInnovation #PatientCare #HealthcareChallenges #MedicalManufacturing #CostEffectiveness #LifeSciences #FierceLifeSciences #WeAreFierce Fierce Life Sciences Events

🧬 Viral Vector Development Trend?🧬 In recent discussions, including a few at ASGCT, I've observed a growing focus on secondary supply options and #feasibilitystudies for viral vector candidates in the #discovery - #preclinical phases. I suspect this trend underscores the importance of not only ensuring a robust supply chain but also, perhaps more importantly, optimizing the design of new vector candidates. 🥇 At DINAMIQS, we excel in both areas. Our track record of success shows that we are capable and nimble. (kudos, Eduard Ayuso and team!) Our team brings extensive expertise in #vectordesign and #optimization, empowering our clients' projects to move forward with confidence. We are committed to helping our clients navigate the complexities of gene therapy development, from enhancing supply chain resilience to refining vector efficiency and functionality. 📞 If you're exploring secondary supply strategies or seeking to optimize new candidates in your pre-clinical pipeline, let’s connect. #ViralVectors #AAV #Lenti #GeneTherapy #Biotech #Innovation #DINAMIQS #CDMO