National Center for Therapeutics Manufacturing (NCTM)’s Post

Amazing video of our new state-of-the-art GMP facility!! In the world of biotech, Good Manufacturing Practices (GMP) are the unsung heroes making sure our latest innovations are not just cool, but also safe and reliable. As we dive into new tech and discoveries, GMP keeps everything on point, from consistency to compliance. Our R&D team is always hard at work bringing new GMP proteins to life. We recently launched our latest additions: IL-12 and IL-18! But that’s not all, we’ve also rolled out GMP Laminin 521 designed for your iPSCs. Whether you’re tackling cutting-edge research or advancing cell therapies, our GMP proteins are here to support your breakthroughs. Stay tuned for more updates and innovations! #Biotech #GMP #proteins #science

Let us help you to optimize your AAV production efficacy with advanced aggregation analysis using TEM. #AAV #TEM #aggregation #QuTEM

Microfluidizer technology is ideal for cell disruption. It utilises lower pressures than other Cell Disruptors on the market, meaning: ✅ less wear ✅ less servicing ✅ more reliability What's more, it achieves better flow rates, less foaming and more effective cooling. Want to know how? Watch the video in the link below ⬇️

I look forward to a productive, insightful discussion with Dr. Peter Marks

Optimize Production Efficacy with Advanced Aggregation Analysis Using TEM  At QuTEM (formerly Vironova BioAnalytics), we provide cutting-edge analytical tools for monitoring particle clusters and aggregates in your samples over time. By leveraging Transmission Electron Microscopy (TEM), we offer precise quantification of individual particles and aggregates, expressed either by total particle count or as a percentage ratio of the sample. This detailed analysis is vital for enhancing the stability and efficacy of virus-based vaccines and gene therapy products. Our expertise in nanoparticle TEM (nsTEM) enables us to visually and quantitatively assess aggregation—a key factor in product performance. Our team employs proprietary software for semi-automated detection and classification of viral particles and aggregates in TEM images. This approach delivers robust, quantitative insights into particle aggregation, supporting the optimization of your biopharmaceutical production processes. Contact us today and learn more about aggregation analysis! #AAV #TEM #QuTEM #aggregation #technology

#Oligonucleotide drugs, as a new class of biomolecular therapeutics, demonstrate significant potential in gene expression regulation through precise targeting of #mRNA. However, the complexity of these drugs presents a series of challenges for preclinical bioanalysis, including demands for detection sensitivity, specificity, and stability.

Whether it’s called cell lysis, cell rupture or cell disruption, it means the same thing. Cell Disruption is a key process for many scientific breakthroughs including gene therapy, diagnostic testing, pharmaceutical development and vaccine production. Cell disruption is the process of breaking cells to recover and maintain the intracellular content integrity with high efficiency. So what role does Microfluidics play in this key process of cell rupture? How does Microfluidizer® Technology compare to other cell disruption methods? Watch our video for an overall understanding of cell disruption, Microfluidics' key role, and how we compare to our competition. https://hubs.la/Q011LCHr0 #celllyse #celldisruption #cellrupture #Microfluidics #Microfluidizerprocessor #Microfluidizertechnology #diagnostictesting #genetherapy #vaccineproduction #celldisruptionmethods

Abzena has announced the launch of its enhanced #bioassay platform EpiScreen® 2.0, a comprehensive suite of assays that predict and evaluate potential risks of preclinical #immunogenicity in protein, antibody, and gene therapy therapeutics. The next generation tool provides a better immunogenic assessment that is highly sensitive, multi-parametric, and data-rich, which ultimately improves candidate selection and de-risks early phase development. Our CSO, Campbell Bunce PhD MBA shares, “We developed EpiScreen® 2.0 because we understand that there are many factors that contribute to the immunogenicity risk of a drug, especially with the next-generation therapeutics being developed like antibody-drug conjugates (#ADCs).  I’m not aware of any other service provider that offers such an extensive set of immunogenicity assessment capabilities covering bioinformatics, proteomics, and ex vivo human immune cell assays underpinned by a high-throughput, high-quality infrastructure for blood processing and storage." Access the press release: https://lnkd.in/gVg_Gmcy #CDMO #CRO #drugdevelopment #biologics #bioconjugates

Only 1 day left to register for our in-person Biologics seminar in Boston where our experts Riya Binil PhD, Mahdi Roohnikan, PhD, Bryant Darnay PhD, and Joe Ehardt will give 5 insightful presentations about the journey of a biologic drug from pre-clinical stages to commercial release. 🔑 Key Takeaways from the event will include: 🔹 Why high-order characterization & cell-based assays are crucial for Phase I & II testing of biologics like cell & gene therapies, ADCs, and mAbs. 🔹 How to tackle structural complexity, stability, and reproducibility challenges for regulatory success. 🔹 Insights from real-world case studies and best practices to help you navigate compliance and commercialization. Click here to view the event details and secure your place: https://bit.ly/3Nz3Dv3 #biologicstesting #biopharmatesting #SGSNorthAmerica

Tomorrow the 27th American Society of Gene & Cell Therapy Annual Meeting starts in #Baltimore. Be sure to visit the Exothera booth #1827 and have a chat with my colleagues Hanna P. Lesch, Emilie Gateau, Patrick Thiaville, Darren Leva, Gavin Allsop, Drew Ward, Andrew Klauk, and Manuel Valdés, PhD and learn more about our process development and cGMP viral vector manufacturing and continuous (no process development required) mRNA manufacturing. You can also view our posters: - Poster #1845: Navigating Pitfalls in the Adenovirus Development: From Drug Discovery to Clinics and Beyond, in collaboration with Cytiva and Valo Therapeutics Ltd - Poster #1355: Revolutionizing mRNA Production: The Paradigm-Breaking Nfinty Continuous RNA system, in collaboration with UNIVERCELLS - Poster #571: Tackling AAV Manufacturing Process Industrialization Challenges Using a Standard Platform Approach.