Lonza’s Post

Is your team developing a biologic or vaccine that needs an agile partner? Lets meet, stop by booth 736 or connect with me within the BPI ConnectMe system! #BPICONF #Resilience #biomanufacturing #biologics #vaccines

#Webinar now available on demand! Integrated plasmid engineering and manufacturing process: a unified approach from lab to clinic Pauline Vieugué (Plasmid Engineering Team Leader, Polyplus now part of Sartorius) and Philippe Ledent (Scientific Manager, Xpress Biologics now part of Sartorius) explore an integrated approach for #plasmidengineering and manufacturing, ensuring the integrity of the therapeutic product from lab research to clinical phases Watch this webinar at your convenience to learn about: • A robust plasmid engineering platform to propel gene therapy projects forward with confidence • Methods to eliminate common industry challenges faced when transitioning from discovery grade to higher-quality production • How to de-risk processes and make them cost-effective

For more than 20 years, we’ve paired exceptional scientific integrity with the practical regulatory insights you need to successfully develop and market your #biotherapeutic. 🥼🧪 Whether you have an oncolytic virus, vaccine, gene therapy, immunotherapy, or other drug, our commitment to you is the same. Discover why #CustomBiologics is your trusted large molecule bioanalytical CRO: https://buff.ly/47pxJtb #bioanalysis #bioanalyticaltesting #CRO #cellbasedbioassay #bioassay #bioanalytical #lab #biologics

And here are the 3 models, showing scale up from the benchtop UF Mini, through to the U2K designed for larger scale processes.

Explore analytical approaches to innovative cell and gene therapies at the annual US Pharmacopeia Biologics Stakeholder Forum. Each year, industry, regulatory, and scientific experts gather to discuss pressing challenges at the interface of biotherapeutic quality and innovation. This year’s forum will focus on the analytical challenges associated with cell and gene therapy products, including shortened development timelines due to accelerated regulatory review, small production batches, and in some cases, short shelf lives. Sessions will explore analytical innovations that efficiently and cost-effectively support process and product understanding, process validation, and product release. For more info and to register, visit: https://ow.ly/IUKQ50QhYrF. #CellTherapies #GeneTherapies #Analytical #NGS #Biologics #USPScience

I was excited to welcome Rajiv Gangurde, Ph.D., the Vice President of Technical Operations, Cell & Gene Therapy at Parexel to the Shurig Solutions, Inc. SSI Executive Conversations Podcast. In Part 1 of our conversation Rajiv and I discuss some important topics relevant to the C&GT industry. With over 1500 clinical trials in progress last February and the recent announcement of the first CRISPR FDA approval, we discuss the current state of C&GT FDA approvals, the challenges around CMC, and the specifics of AAV-based gene therapy. https://lnkd.in/ePmHsRk8 #cellandgenetherapy #innovation #clinicaltrials #cmc #regulatorypathway #biotechnology #pharmaceutical

Recently, I had an engaging and informative conversation with Neil Templeton. We delved into the intricacies of the biotech industry, discussing the variety of modalities and the specific challenges of process development and scaling up. Neil's commitment to making gene therapy more accessible and his strategic approach to reducing development and manufacturing costs inspired me. This conversation: 1. Challenged me to consider the shared and contrasting elements of process development across biologics, vaccines, and cell and gene therapy manufacturing. 2. I learned a lot about how harnessing expertise from the biologics sector can have far-reaching benefits in other areas. 3. Reminded me of the importance of Design of Experiment (DOE) and its role in understanding critical process parameters. ❓What have you enjoyed most in this Smart Biotech Scientist episode? #cellculture #processdevelopment #bioprocessing #cgt #biotech

Integrated plasmid engineering and manufacturing process: a unified approach from lab to clinic This month, join Pauline Vieugué (Plasmid Engineering Team Leader, Polyplus) and Philippe Ledent (Scientific Manager, Xpress Biologics) as they explore an integrated approach for #plasmidengineering and manufacturing, ensuring the integrity of the therapeutic product from lab research to clinical phases Attend to learn about: • A robust plasmid engineering platform to propel gene therapy projects forward with confidence • Methods to eliminate common industry challenges faced when transitioning from discovery grade to higher-quality production • How to de-risk processes and make them cost-effective Register for this upcoming #webinar below:

#QuadplexdPCR as a tool to analyze #genomeintegrity and heterogeneity in gene therapy drug products The rapid growth of the #genetherapy field necessitates product-specific analytics, as critical quality attributes do not consistently correlate with drug potency or safety. It is hypothesized that the heterogeneity of packaged genomes contributes to this inconsistency. Next month, Ryan Massopust (Scientist II, Analytical Development, Asklepios BioPharmaceutical, Inc. (AskBio)) will explore a quadplex digital PCR (#dPCR) assay, employing four primer probe sets that span the genome from promoter to poly(A) signal sequence, that was developed to investigate this hypothesis. Register for this upcoming #webinar below:

🎥 Exciting times ahead as we unveil another insightful video in our Advanced Therapies Week 20-year anniversary series! Dive into the wisdom of Miguel Forte, President-Elect of the International ISCT, International Society for Cell & Gene Therapy and a seasoned pharmaceutical industry executive with over 20 years of experience. From R&D to Manufacturing and Medical, Miguel's journey is a testament to dedication and innovation in the field. 👉 Watch below #AdvancedTherapiesWeek #CellGeneTherapy #MiguelForteInsights