Insider News
Sep 9, 2024
Sep 23, 2024
BioProcess Insider Daily - Biotech Week Boston
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Smaller innovators are more likely to be upended by US legislation aimed at restricting working with China-based CDMOs like WuXi Biologics, according to Latham Biopharm.
Vertex says finding the sweet spot in manufacturing capacity is key to ensuring the successful rollout of sickle cell gene therapy Casgevy (exagamglogene autotemcel).
A President Biden Executive Order supporting homegrown biomanufacturing will remain in place whoever wins in November, White House OSTP assistant director Sarah Glaven told Biotech Week Boston delegates.
CDMO Resilience hosted visitors at its Boston manufacturing site during Biotech Week Boston.
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From Pipettes to Infusion Pumps: Volume Accuracy in Regulated Industries and Its Critical Impact
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Special Reports
As the monoclonal-antibody (mAb) market continues to grow, it is becoming increasingly important for pharmaceutical and biotech companies to accelerate process development and establish a scalable manufacturing process capable of achieving high titers and consistent product quality. Central to this is a cell culture media and feed system that can provide the required nutrients for optimal cell growth, viability, and function, as well as facilitate a seamless transition from development to clinical and commercial manufacturing. However, choosing an appropriate system can be a complex and time-consuming process, often requiring the evaluation of multiple medium and feed options. Platform systems, consisting of a medium and complementary feed developed for a specific cell line and application, have emerged as a valuable option for developers to help simplify selection and increase scale-up efficiency. To meet the need for high-performance platform mAb manufacturing solutions, Thermo Fisher Scientific has dev...
Precision in volume delivery is critically important for both the biopharmaceutical and medical device industries. This special report discusses how accurate volume measurement affects patient safety, product quality, and regulatory compliance. Sartorius emphasizes the roles that infusion pumps, laboratory pipettes, and quality control (QC) measures play in ensuring reliable and reproducible results. Register or Login and hit Download Now to get the full Special Report.
Ask the Expert Webcasts
This webcast features: Adam Nelson, Chromatography Product Manager, Repligen. Pre-packed chromatography columns have emerged as a valuable tool in process development, clinical manufacturing, and commercial production, offering significant advantages over self-packed columns. The adoption of pre-packed columns aligns with lean manufacturing best practices, which emphasize the reduction of non-value-adding activities. This study evaluates the benefits of using pre-packed columns in biopharmaceutical production. Pre-packed columns are pre-validated and ready-to-use, eliminating the time-consuming and labor-intensive steps associated with self-packing. This results in substantial time savings and improved operational efficiency. By reducing the risk of human error delays during column packing, pre-packed columns enhance process consistency and reliability, leading to improved product quality. Key takeaways: In conclusion, pre-packed chromatography columns offer a strategic advantage in biopharmaceutical m...
This webcast features: Roland Pach, PhD, Global Analytical Expert, CMC, CGT, & Alternative Formats, Roche. Gene therapy based therapeutics offer revolutionary ways of treating and curing genetic disorders. CMC plays a crucial part, however it is faced with complex manufacturing processes and the intrinsic complexity of the genetic therapeutics themselves. In this webinar, learn about key pre-quality attributes in AAV manufacturing and the cognate landscape of technologies analyzing them. There is a high need for more sophisticated methods for improving and deepening the understanding of the process and product. Key Takeaways: Register or Login and hit Watch on Demand to view the recorded webcast now.
